Difference between revisions of "Rhabdomyosarcoma, pediatric - historical"
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Warner-admin (talk | contribs) m (Text replacement - "2.2 g/m<sup>2</sup> IV infusion over" to "2200 mg/m<sup>2</sup> IV over") |
Warner-admin (talk | contribs) m (Text replacement - "As a general rule, this includes the inferior arm(s) of a randomized study, unless said regimens continue to be recommended by trustworthy sources such as the [http://www.nccn.org/professionals/physician_gls/f_guidelines.asp NCCN Guidelines]. " to "") |
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[[#top|Back to Top]] | [[#top|Back to Top]] | ||
</div> | </div> | ||
| − | The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only | + | The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. Is there a regimen missing from this list? See the [[Rhabdomyosarcoma, pediatric|pediatric rhabdomyosarcoma page]] for current regimens. |
{| class="wikitable" style="float:right; margin-right: 5px;" | {| class="wikitable" style="float:right; margin-right: 5px;" | ||
|- | |- | ||
| Line 12: | Line 12: | ||
=Unstratified, all lines of therapy= | =Unstratified, all lines of therapy= | ||
==Dactinomycin monotherapy {{#subobject:a9367b|Regimen=1}}== | ==Dactinomycin monotherapy {{#subobject:a9367b|Regimen=1}}== | ||
| − | <div class="toccolours" style="background-color:# | + | <div class="toccolours" style="background-color:#ee6b6e"> |
===Regimen {{#subobject:43c238|Variant=1}}=== | ===Regimen {{#subobject:43c238|Variant=1}}=== | ||
{| class="wikitable" style="width: 40%; text-align:center;" | {| class="wikitable" style="width: 40%; text-align:center;" | ||
| Line 28: | Line 28: | ||
===References=== | ===References=== | ||
# Pinkel D. Actinomycin D in childhood cancer; a preliminary report. Pediatrics. 1959 Feb;23(2):342-7. [https://doi.org/10.1542/peds.23.2.342 link to original article] [https://pubmed.ncbi.nlm.nih.gov/13633349/ PubMed] | # Pinkel D. Actinomycin D in childhood cancer; a preliminary report. Pediatrics. 1959 Feb;23(2):342-7. [https://doi.org/10.1542/peds.23.2.342 link to original article] [https://pubmed.ncbi.nlm.nih.gov/13633349/ PubMed] | ||
| − | =High | + | =High-risk, all lines of therapy= |
==COG D9802 VCPT Alternating with VAC Arm== | ==COG D9802 VCPT Alternating with VAC Arm== | ||
<div class="toccolours" style="background-color:#c8a2c8"> | <div class="toccolours" style="background-color:#c8a2c8"> | ||
| Line 41: | Line 41: | ||
|- | |- | ||
|} | |} | ||
| − | <div class="toccolours" style="background-color:# | + | <div class="toccolours" style="background-color:#ee6b6e"> |
| − | === | + | ===Irinotecan window=== |
<div class="toccolours" style="background-color:#b3e2cd"> | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy, Week 0 (VCPT)==== | ====Chemotherapy, Week 0 (VCPT)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
| − | *[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 | + | *[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 to 5, given after vincristine on day 1 |
| − | |||
====Chemotherapy, Week 1 (VCPT)==== | ====Chemotherapy, Week 1 (VCPT)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
| − | *[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 | + | *[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 to 5, given after vincristine on day 1 |
| − | |||
====Chemotherapy, Week 2 Off Chemo==== | ====Chemotherapy, Week 2 Off Chemo==== | ||
====Chemotherapy, Week 3 (VCPT)==== | ====Chemotherapy, Week 3 (VCPT)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
| − | *[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 | + | *[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 to 5, given after vincristine on day 1 |
| − | |||
====Chemotherapy, Week 4 (VCPT)==== | ====Chemotherapy, Week 4 (VCPT)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
| − | *[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 | + | *[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 to 5, given after vincristine on day 1 |
| − | |||
'''Evaluation during week 5, followed by:''' | '''Evaluation during week 5, followed by:''' | ||
</div></div><br> | </div></div><br> | ||
| − | <div class="toccolours" style="background-color:# | + | <div class="toccolours" style="background-color:#ee6b6e"> |
===Induction=== | ===Induction=== | ||
<div class="toccolours" style="background-color:#b3e2cd"> | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy, Week 6 (VAC)==== | ====Chemotherapy, Week 6 (VAC)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
*[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | *[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | ||
| − | ** | + | **1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1 |
*[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | *[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 2200 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on day 1 |
| − | ** | + | **1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
| − | ** | + | **Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
====Supportive Medications, Week 6==== | ====Supportive Medications, Week 6==== | ||
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 440 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **1 year old or older: 14.6 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **Younger than 1 year old: 7.2 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
====Chemotherapy, Week 7 (Vincristine)==== | ====Chemotherapy, Week 7 (Vincristine)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 8 (Vincristine)==== | ====Chemotherapy, Week 8 (Vincristine)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 9 (VCPT)==== | ====Chemotherapy, Week 9 (VCPT)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
| − | *[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 | + | *[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 to 5, given after vincristine on day 1 |
| − | |||
====Chemotherapy, Week 10 (VCPT)==== | ====Chemotherapy, Week 10 (VCPT)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
| − | *[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 | + | *[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 to 5, given after vincristine on day 1 |
| − | |||
====Chemotherapy, Week 11 (Vincristine)==== | ====Chemotherapy, Week 11 (Vincristine)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 12 (VAC)==== | ====Chemotherapy, Week 12 (VAC)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
*[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | *[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | ||
| − | ** | + | **1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1 |
*[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | *[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 2200 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on day 1 |
| − | ** | + | **1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
| − | ** | + | **Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
====Supportive Medications, Week 12==== | ====Supportive Medications, Week 12==== | ||
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 440 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **1 year old or older: 14.6 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **Younger than 1 year old: 7.2 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
====Chemotherapy, Week 13 (Vincristine)==== | ====Chemotherapy, Week 13 (Vincristine)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
'''Evaluation during week 14, followed by:''' | '''Evaluation during week 14, followed by:''' | ||
====Chemotherapy, Week 15 (Vincristine)==== | ====Chemotherapy, Week 15 (Vincristine)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 16 (VC)==== | ====Chemotherapy, Week 16 (VC)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
*[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | *[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 2200 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on day 1 |
| − | ** | + | **1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
| − | ** | + | **Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
====Supportive Medications, Week 16==== | ====Supportive Medications, Week 16==== | ||
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 440 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **1 year old or older: 14.6 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **Younger than 1 year old: 7.2 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
====Chemotherapy, Week 17 (Vincristine)==== | ====Chemotherapy, Week 17 (Vincristine)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 18 (Vincristine)==== | ====Chemotherapy, Week 18 (Vincristine)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 19 (VC)==== | ====Chemotherapy, Week 19 (VC)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
*[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | *[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 2200 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on day 1 |
| − | ** | + | **1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
| − | ** | + | **Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
====Supportive Medications, Week 19==== | ====Supportive Medications, Week 19==== | ||
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 440 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **1 year old or older: 14.6 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **Younger than 1 year old: 7.2 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
====Chemotherapy, Week 20 through 22 Off Chemo==== | ====Chemotherapy, Week 20 through 22 Off Chemo==== | ||
====Chemotherapy, Week 23 (VAC)==== | ====Chemotherapy, Week 23 (VAC)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
*[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | *[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | ||
| − | ** | + | **1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1 |
*[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | *[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 2200 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on day 1 |
| − | ** | + | **1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
| − | ** | + | **Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
====Supportive Medications, Week 23==== | ====Supportive Medications, Week 23==== | ||
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 440 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **1 year old or older: 14.6 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **Younger than 1 year old: 7.2 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
====Chemotherapy, Week 24 (Vincristine)==== | ====Chemotherapy, Week 24 (Vincristine)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 25 (Eval/Vincristine)==== | ====Chemotherapy, Week 25 (Eval/Vincristine)==== | ||
*Evaluation Week | *Evaluation Week | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
</div></div><br> | </div></div><br> | ||
| − | <div class="toccolours" style="background-color:# | + | <div class="toccolours" style="background-color:#ee6b6e"> |
===Continuation=== | ===Continuation=== | ||
<div class="toccolours" style="background-color:#b3e2cd"> | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy, Week 26 (VCPT)==== | ====Chemotherapy, Week 26 (VCPT)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
| − | *[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 | + | *[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 to 5, given after vincristine on day 1 |
| − | |||
====Chemotherapy, Week 27 (VCPT)==== | ====Chemotherapy, Week 27 (VCPT)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
| − | *[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 | + | *[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 to 5, given after vincristine on day 1 |
| − | |||
====Chemotherapy, Week 28 Off Chemo==== | ====Chemotherapy, Week 28 Off Chemo==== | ||
====Chemotherapy, Week 29 (VAC)==== | ====Chemotherapy, Week 29 (VAC)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
*[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | *[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | ||
| − | ** | + | **1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1 |
*[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | *[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 2200 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on day 1 |
| − | ** | + | **1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
| − | ** | + | **Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
====Supportive Medications, Week 29==== | ====Supportive Medications, Week 29==== | ||
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 440 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **1 year old or older: 14.6 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **Younger than 1 year old: 7.2 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
====Chemotherapy, Week 30 through 31 Off Chemo==== | ====Chemotherapy, Week 30 through 31 Off Chemo==== | ||
====Chemotherapy, Week 32 (VCPT)==== | ====Chemotherapy, Week 32 (VCPT)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
| − | *[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 | + | *[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 to 5, given after vincristine on day 1 |
| − | |||
====Chemotherapy, Week 33 (VCPT)==== | ====Chemotherapy, Week 33 (VCPT)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
| − | *[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 | + | *[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 to 5, given after vincristine on day 1 |
| − | |||
====Chemotherapy, Week 34 (Vincristine)==== | ====Chemotherapy, Week 34 (Vincristine)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 35 (VAC)==== | ====Chemotherapy, Week 35 (VAC)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
*[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | *[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | ||
| − | ** | + | **1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1 |
*[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | *[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 2200 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on day 1 |
| − | ** | + | **1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
| − | ** | + | **Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
====Supportive Medications, Week 35==== | ====Supportive Medications, Week 35==== | ||
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 440 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **1 year old or older: 14.6 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **Younger than 1 year old: 7.2 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
====Chemotherapy, Week 36 through 37 Off Chemo==== | ====Chemotherapy, Week 36 through 37 Off Chemo==== | ||
====Chemotherapy, Week 38 (VCPT)==== | ====Chemotherapy, Week 38 (VCPT)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
| − | *[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 | + | *[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 to 5, given after vincristine on day 1 |
| − | |||
====Chemotherapy, Week 39 (VCPT)==== | ====Chemotherapy, Week 39 (VCPT)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
| − | *[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 | + | *[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 to 5, given after vincristine on day 1 |
| − | |||
====Chemotherapy, Week 40 Off Chemo==== | ====Chemotherapy, Week 40 Off Chemo==== | ||
====Chemotherapy, Week 41 (VAC)==== | ====Chemotherapy, Week 41 (VAC)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
*[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | *[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | ||
| − | ** | + | **1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1 |
*[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | *[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 2200 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on day 1 |
| − | ** | + | **1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
| − | ** | + | **Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
====Supportive Medications, Week 41==== | ====Supportive Medications, Week 41==== | ||
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 440 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **1 year old or older: 14.6 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **Younger than 1 year old: 7.2 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
'''Evaluation during week 44''' | '''Evaluation during week 44''' | ||
</div></div></div> | </div></div></div> | ||
===References=== | ===References=== | ||
| − | # '''COG D9802:''' Pappo AS, Lyden E, Breitfeld P, Donaldson SS, Wiener E, Parham D, Crews KR, Houghton P, Meyer WH. Two Consecutive Phase II Window Trials of Irinotecan Alone or in Combination With vincristine for the Treatment of Metastatic Rhabdomyosarcoma: The Children's Oncology Group. J Clin Oncol. 2007 Feb 1;25(4):362-9. [https://doi.org/10.1200/JCO.2006.07.1720 link to original article] [https://pubmed.ncbi.nlm.nih.gov/17264331/ PubMed] NCT00003955 | + | # '''COG D9802:''' Pappo AS, Lyden E, Breitfeld P, Donaldson SS, Wiener E, Parham D, Crews KR, Houghton P, Meyer WH. Two Consecutive Phase II Window Trials of Irinotecan Alone or in Combination With vincristine for the Treatment of Metastatic Rhabdomyosarcoma: The Children's Oncology Group. J Clin Oncol. 2007 Feb 1;25(4):362-9. [https://doi.org/10.1200/JCO.2006.07.1720 link to original article] [https://pubmed.ncbi.nlm.nih.gov/17264331/ PubMed] [https://clinicaltrials.gov/study/NCT00003955 NCT00003955] |
==COG D9802 VAC Alone Arm== | ==COG D9802 VAC Alone Arm== | ||
<div class="toccolours" style="background-color:#c8a2c8"> | <div class="toccolours" style="background-color:#c8a2c8"> | ||
| Line 341: | Line 329: | ||
|- | |- | ||
|} | |} | ||
| − | <div class="toccolours" style="background-color:# | + | <div class="toccolours" style="background-color:#ee6b6e"> |
| − | === | + | ===Irinotecan window=== |
<div class="toccolours" style="background-color:#b3e2cd"> | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy, Week 0 (VCPT)==== | ====Chemotherapy, Week 0 (VCPT)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
| − | *[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 | + | *[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 to 5, given after vincristine on day 1 |
| − | |||
====Chemotherapy, Week 1 (VCPT)==== | ====Chemotherapy, Week 1 (VCPT)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
| − | *[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 | + | *[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 to 5, given after vincristine on day 1 |
| − | |||
====Chemotherapy, Week 2 Off Chemo==== | ====Chemotherapy, Week 2 Off Chemo==== | ||
====Chemotherapy, Week 3 (VCPT)==== | ====Chemotherapy, Week 3 (VCPT)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
| − | *[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 | + | *[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 to 5, given after vincristine on day 1 |
| − | |||
====Chemotherapy, Week 4 (VCPT)==== | ====Chemotherapy, Week 4 (VCPT)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
| − | *[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 | + | *[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 to 5, given after vincristine on day 1 |
| − | |||
'''Evaluation during week 5, followed by:''' | '''Evaluation during week 5, followed by:''' | ||
</div></div><br> | </div></div><br> | ||
| − | <div class="toccolours" style="background-color:# | + | <div class="toccolours" style="background-color:#ee6b6e"> |
===Induction=== | ===Induction=== | ||
<div class="toccolours" style="background-color:#b3e2cd"> | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy, Week 6 (VAC)==== | ====Chemotherapy, Week 6 (VAC)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
*[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | *[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | ||
| − | ** | + | **1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1 |
*[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | *[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 2200 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on day 1 |
| − | ** | + | **1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
| − | ** | + | **Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
====Supportive Medications, Week 6==== | ====Supportive Medications, Week 6==== | ||
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 440 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **1 year old or older: 14.6 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **Younger than 1 year old: 7.2 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
====Chemotherapy, Week 7 (Vincristine)==== | ====Chemotherapy, Week 7 (Vincristine)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 8 (Vincristine)==== | ====Chemotherapy, Week 8 (Vincristine)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 9 (VCPT)==== | ====Chemotherapy, Week 9 (VCPT)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
| − | *[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 | + | *[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 to 5, given after vincristine on day 1 |
| − | |||
====Chemotherapy, Week 10 (VCPT)==== | ====Chemotherapy, Week 10 (VCPT)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
| − | *[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 | + | *[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 to 5, given after vincristine on day 1 |
| − | |||
====Chemotherapy, Week 11 (Vincristine)==== | ====Chemotherapy, Week 11 (Vincristine)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 12 (VAC)==== | ====Chemotherapy, Week 12 (VAC)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
*[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | *[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | ||
| − | ** | + | **1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1 |
*[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | *[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 2200 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on day 1 |
| − | ** | + | **1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
| − | ** | + | **Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
====Supportive Medications, Week 12==== | ====Supportive Medications, Week 12==== | ||
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 440 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **1 year old or older: 14.6 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **Younger than 1 year old: 7.2 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
====Chemotherapy, Week 13 (Vincristine)==== | ====Chemotherapy, Week 13 (Vincristine)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
'''Evaluation during week 14, followed by:''' | '''Evaluation during week 14, followed by:''' | ||
====Chemotherapy, Week 15 (Vincristine)==== | ====Chemotherapy, Week 15 (Vincristine)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 16 (VC)==== | ====Chemotherapy, Week 16 (VC)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
*[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | *[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 2200 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on day 1 |
| − | ** | + | **1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
| − | ** | + | **Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
====Supportive Medications, Week 16==== | ====Supportive Medications, Week 16==== | ||
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 440 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **1 year old or older: 14.6 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **Younger than 1 year old: 7.2 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
====Chemotherapy, Week 17 (Vincristine)==== | ====Chemotherapy, Week 17 (Vincristine)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 18 (Vincristine)==== | ====Chemotherapy, Week 18 (Vincristine)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 19 (VC)==== | ====Chemotherapy, Week 19 (VC)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
*[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | *[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 2200 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on day 1 |
| − | ** | + | **1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
| − | ** | + | **Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
====Supportive Medications, Week 19==== | ====Supportive Medications, Week 19==== | ||
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 440 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **1 year old or older: 14.6 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **Younger than 1 year old: 7.2 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
====Chemotherapy, Week 20 through 22 Off Chemo==== | ====Chemotherapy, Week 20 through 22 Off Chemo==== | ||
====Chemotherapy, Week 23 (VAC)==== | ====Chemotherapy, Week 23 (VAC)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
*[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | *[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | ||
| − | ** | + | **1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1 |
*[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | *[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 2200 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on day 1 |
| − | ** | + | **1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
| − | ** | + | **Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
====Supportive Medications, Week 23==== | ====Supportive Medications, Week 23==== | ||
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 440 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **1 year old or older: 14.6 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **Younger than 1 year old: 7.2 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
====Chemotherapy, Week 24 (Vincristine)==== | ====Chemotherapy, Week 24 (Vincristine)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 25 (Evaluation/Vincristine)==== | ====Chemotherapy, Week 25 (Evaluation/Vincristine)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
</div></div><br> | </div></div><br> | ||
| − | <div class="toccolours" style="background-color:# | + | <div class="toccolours" style="background-color:#ee6b6e"> |
===Continuation=== | ===Continuation=== | ||
<div class="toccolours" style="background-color:#b3e2cd"> | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy, Week 26 (VAC)==== | ====Chemotherapy, Week 26 (VAC)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
*[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | *[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | ||
| − | ** | + | **1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1 |
*[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | *[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 2200 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on day 1 |
| − | ** | + | **1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
| − | ** | + | **Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
====Supportive Medications, Week 26==== | ====Supportive Medications, Week 26==== | ||
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 440 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **1 year old or older: 14.6 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **Younger than 1 year old: 7.2 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
====Chemotherapy, Week 27 (VCR)==== | ====Chemotherapy, Week 27 (VCR)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 28 Off Chemo==== | ====Chemotherapy, Week 28 Off Chemo==== | ||
====Chemotherapy, Week 29 (VAC)==== | ====Chemotherapy, Week 29 (VAC)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
*[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | *[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | ||
| − | ** | + | **1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1 |
*[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | *[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 2200 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on day 1 |
| − | ** | + | **1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
| − | ** | + | **Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
====Supportive Medications, Week 29==== | ====Supportive Medications, Week 29==== | ||
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 440 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **1 year old or older: 14.6 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **Younger than 1 year old: 7.2 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
====Chemotherapy, Week 30 through 31 Off Chemo==== | ====Chemotherapy, Week 30 through 31 Off Chemo==== | ||
====Chemotherapy, Week 32 (VAC)==== | ====Chemotherapy, Week 32 (VAC)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
*[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | *[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | ||
| − | ** | + | **1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1 |
*[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | *[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 2200 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on day 1 |
| − | ** | + | **1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
| − | ** | + | **Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
====Supportive Medications, Week 32==== | ====Supportive Medications, Week 32==== | ||
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 440 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **1 year old or older: 14.6 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **Younger than 1 year old: 7.2 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
====Chemotherapy, Week 33 (VCR)==== | ====Chemotherapy, Week 33 (VCR)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 34 (Vincristine)==== | ====Chemotherapy, Week 34 (Vincristine)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 35 (VAC)==== | ====Chemotherapy, Week 35 (VAC)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
*[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | *[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | ||
| − | ** | + | **1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1 |
*[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | *[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 2200 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on day 1 |
| − | ** | + | **1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
| − | ** | + | **Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
====Supportive Medications, Week 35==== | ====Supportive Medications, Week 35==== | ||
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 440 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **1 year old or older: 14.6 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **Younger than 1 year old: 7.2 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
====Chemotherapy, Week 36 through 37 Off Chemo==== | ====Chemotherapy, Week 36 through 37 Off Chemo==== | ||
====Chemotherapy, Week 38 (VAC)==== | ====Chemotherapy, Week 38 (VAC)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
*[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | *[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | ||
| − | ** | + | **1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1 |
*[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | *[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 2200 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on day 1 |
| − | ** | + | **1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
| − | ** | + | **Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
====Supportive Medications, Week 38==== | ====Supportive Medications, Week 38==== | ||
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 440 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **1 year old or older: 14.6 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **Younger than 1 year old: 7.2 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
====Chemotherapy, Week 39 through 40 Off Chemo==== | ====Chemotherapy, Week 39 through 40 Off Chemo==== | ||
====Chemotherapy, Week 41 (VAC)==== | ====Chemotherapy, Week 41 (VAC)==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
*[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | *[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | ||
| − | ** | + | **1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1 |
*[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | *[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 2200 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on day 1 |
| − | ** | + | **1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
| − | ** | + | **Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
====Supportive Medications, Week 41==== | ====Supportive Medications, Week 41==== | ||
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 440 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **1 year old or older: 14.6 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **Younger than 1 year old: 7.2 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
'''Evaluation during week 44''' | '''Evaluation during week 44''' | ||
</div></div></div> | </div></div></div> | ||
===References=== | ===References=== | ||
| − | # '''COG D9802:''' Pappo AS, Lyden E, Breitfeld P, Donaldson SS, Wiener E, Parham D, Crews KR, Houghton P, Meyer WH. Two Consecutive Phase II Window Trials of Irinotecan Alone or in Combination With vincristine for the Treatment of Metastatic Rhabdomyosarcoma: The Children's Oncology Group. J Clin Oncol. 2007 Feb 1;25(4):362-9. [https://doi.org/10.1200/JCO.2006.07.1720 link to original article] [https://pubmed.ncbi.nlm.nih.gov/17264331/ PubMed] NCT00003955 | + | # '''COG D9802:''' Pappo AS, Lyden E, Breitfeld P, Donaldson SS, Wiener E, Parham D, Crews KR, Houghton P, Meyer WH. Two Consecutive Phase II Window Trials of Irinotecan Alone or in Combination With vincristine for the Treatment of Metastatic Rhabdomyosarcoma: The Children's Oncology Group. J Clin Oncol. 2007 Feb 1;25(4):362-9. [https://doi.org/10.1200/JCO.2006.07.1720 link to original article] [https://pubmed.ncbi.nlm.nih.gov/17264331/ PubMed] [https://clinicaltrials.gov/study/NCT00003955 NCT00003955] |
| − | =Low | + | =Low-risk, all lines of therapy= |
| − | ==COG D9602 Subgroup A Clinical Group 1== | + | ==COG D9602 Subgroup A Clinical Group 1 protocol== |
| − | <div class="toccolours" style="background-color:# | + | <div class="toccolours" style="background-color:#ee6b6e"> |
===Regimen=== | ===Regimen=== | ||
{| class="wikitable sortable" style="width: 60%; text-align:center;" | {| class="wikitable sortable" style="width: 60%; text-align:center;" | ||
| Line 665: | Line 647: | ||
====Chemotherapy, Week 0==== | ====Chemotherapy, Week 0==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
*[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | *[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | ||
| − | ** | + | **1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1 |
====Chemotherapy, Week 1==== | ====Chemotherapy, Week 1==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 2==== | ====Chemotherapy, Week 2==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 3==== | ====Chemotherapy, Week 3==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
*[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | *[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | ||
| − | ** | + | **1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1 |
| − | |||
====Chemotherapy, Week 4==== | ====Chemotherapy, Week 4==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 5==== | ====Chemotherapy, Week 5==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 6==== | ====Chemotherapy, Week 6==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
*[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | *[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | ||
| − | ** | + | **1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1 |
====Chemotherapy, Week 7==== | ====Chemotherapy, Week 7==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 8==== | ====Chemotherapy, Week 8==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 9==== | ====Chemotherapy, Week 9==== | ||
*[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | *[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | ||
| − | ** | + | **1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1 |
| − | '''12-week cycle for 4 cycles | + | '''12-week cycle for 4 cycles; beginning on weeks 0, 12, 24, 36''' |
</div></div> | </div></div> | ||
===References=== | ===References=== | ||
| − | #'''IRSG D9602:''' Raney RB, Walterhouse DO, Meza JL, Andrassy RJ, Breneman JC, Crist WM, Maurer HM, Meyer WH, Parham DM, Anderson JR. Results of the Intergroup Rhabdomyosarcoma Study Group D9602 protocol, using vincristine and dactinomycin with or without cyclophosphamide and radiation therapy, for newly diagnosed patients with low-risk embryonal rhabdomyosarcoma: a report from the Soft Tissue Sarcoma Committee of the Children's Oncology Group. J Clin Oncol. 2011 Apr 1;29(10):1312-8. [https://doi.org/10.1200/JCO.2010.30.4469 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3083999/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/ | + | #'''IRSG D9602:''' Raney RB, Walterhouse DO, Meza JL, Andrassy RJ, Breneman JC, Crist WM, Maurer HM, Meyer WH, Parham DM, Anderson JR. Results of the Intergroup Rhabdomyosarcoma Study Group D9602 protocol, using vincristine and dactinomycin with or without cyclophosphamide and radiation therapy, for newly diagnosed patients with low-risk embryonal rhabdomyosarcoma: a report from the Soft Tissue Sarcoma Committee of the Children's Oncology Group. J Clin Oncol. 2011 Apr 1;29(10):1312-8. [https://doi.org/10.1200/JCO.2010.30.4469 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3083999/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/21357783/ PubMed] [https://clinicaltrials.gov/study/NCT00002995 NCT00002995] |
| − | ==COG D9602 Subgroup A Clinical Group 2== | + | ==COG D9602 Subgroup A Clinical Group 2 protocol== |
| − | <div class="toccolours" style="background-color:# | + | <div class="toccolours" style="background-color:#ee6b6e"> |
===Regimen=== | ===Regimen=== | ||
{| class="wikitable sortable" style="width: 60%; text-align:center;" | {| class="wikitable sortable" style="width: 60%; text-align:center;" | ||
| Line 743: | Line 724: | ||
====Chemotherapy, Week 0==== | ====Chemotherapy, Week 0==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
*[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | *[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | ||
| − | ** | + | **1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1 |
====Chemotherapy, Week 1==== | ====Chemotherapy, Week 1==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 2==== | ====Chemotherapy, Week 2==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 3==== | ====Chemotherapy, Week 3==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
*[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | *[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | ||
| − | ** | + | **1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1 |
====Radiotherapy, Week 3==== | ====Radiotherapy, Week 3==== | ||
| − | *[[External beam radiotherapy]] | + | *[[External beam radiotherapy]] 3600 cGy given once per day in 20 divided fractions |
====Chemotherapy, Week 4==== | ====Chemotherapy, Week 4==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 5==== | ====Chemotherapy, Week 5==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 6==== | ====Chemotherapy, Week 6==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 7==== | ====Chemotherapy, Week 7==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 8==== | ====Chemotherapy, Week 8==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 9==== | ====Chemotherapy, Week 9==== | ||
*[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | *[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | ||
| − | ** | + | **1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1 |
| − | '''12-week cycle for 4 cycles | + | '''12-week cycle for 4 cycles; beginning on weeks 0, 12, 24, 36''' |
</div></div> | </div></div> | ||
===References=== | ===References=== | ||
| − | #'''IRSG D9602:''' Raney RB, Walterhouse DO, Meza JL, Andrassy RJ, Breneman JC, Crist WM, Maurer HM, Meyer WH, Parham DM, Anderson JR. Results of the Intergroup Rhabdomyosarcoma Study Group D9602 protocol, using vincristine and dactinomycin with or without cyclophosphamide and radiation therapy, for newly diagnosed patients with low-risk embryonal rhabdomyosarcoma: a report from the Soft Tissue Sarcoma Committee of the Children's Oncology Group. J Clin Oncol. 2011 Apr 1;29(10):1312-8. [https://doi.org/10.1200/JCO.2010.30.4469 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3083999/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/ | + | #'''IRSG D9602:''' Raney RB, Walterhouse DO, Meza JL, Andrassy RJ, Breneman JC, Crist WM, Maurer HM, Meyer WH, Parham DM, Anderson JR. Results of the Intergroup Rhabdomyosarcoma Study Group D9602 protocol, using vincristine and dactinomycin with or without cyclophosphamide and radiation therapy, for newly diagnosed patients with low-risk embryonal rhabdomyosarcoma: a report from the Soft Tissue Sarcoma Committee of the Children's Oncology Group. J Clin Oncol. 2011 Apr 1;29(10):1312-8. [https://doi.org/10.1200/JCO.2010.30.4469 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3083999/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/21357783/ PubMed] [https://clinicaltrials.gov/study/NCT00002995 NCT00002995] |
| − | ==COG D9602 Subgroup A Clinical Group 3== | + | ==COG D9602 Subgroup A Clinical Group 3 protocol== |
| − | <div class="toccolours" style="background-color:# | + | <div class="toccolours" style="background-color:#ee6b6e"> |
===Regimen=== | ===Regimen=== | ||
{| class="wikitable sortable" style="width: 60%; text-align:center;" | {| class="wikitable sortable" style="width: 60%; text-align:center;" | ||
| Line 819: | Line 800: | ||
====Chemotherapy, Week 0==== | ====Chemotherapy, Week 0==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
*[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | *[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | ||
| − | ** | + | **1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1 |
====Chemotherapy, Week 1==== | ====Chemotherapy, Week 1==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 2==== | ====Chemotherapy, Week 2==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 3==== | ====Chemotherapy, Week 3==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
*[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | *[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | ||
| − | ** | + | **1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1 |
====Radiotherapy, Week 3==== | ====Radiotherapy, Week 3==== | ||
| − | *[[External beam radiotherapy]] | + | *[[External beam radiotherapy]] 4500 cGy given once per day in 25 divided fractions |
====Chemotherapy, Week 4==== | ====Chemotherapy, Week 4==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 5==== | ====Chemotherapy, Week 5==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 6==== | ====Chemotherapy, Week 6==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 7==== | ====Chemotherapy, Week 7==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 8==== | ====Chemotherapy, Week 8==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 9==== | ====Chemotherapy, Week 9==== | ||
*[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | *[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | ||
| − | ** | + | **1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1 |
| − | '''12-week cycle for 4 cycles | + | '''12-week cycle for 4 cycles; beginning on weeks 0, 12, 24, 36''' |
</div></div> | </div></div> | ||
===References=== | ===References=== | ||
| − | #'''IRSG D9602:''' Raney RB, Walterhouse DO, Meza JL, Andrassy RJ, Breneman JC, Crist WM, Maurer HM, Meyer WH, Parham DM, Anderson JR. Results of the Intergroup Rhabdomyosarcoma Study Group D9602 protocol, using vincristine and dactinomycin with or without cyclophosphamide and radiation therapy, for newly diagnosed patients with low-risk embryonal rhabdomyosarcoma: a report from the Soft Tissue Sarcoma Committee of the Children's Oncology Group. J Clin Oncol. 2011 Apr 1;29(10):1312-8. [https://doi.org/10.1200/JCO.2010.30.4469 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3083999/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/ | + | #'''IRSG D9602:''' Raney RB, Walterhouse DO, Meza JL, Andrassy RJ, Breneman JC, Crist WM, Maurer HM, Meyer WH, Parham DM, Anderson JR. Results of the Intergroup Rhabdomyosarcoma Study Group D9602 protocol, using vincristine and dactinomycin with or without cyclophosphamide and radiation therapy, for newly diagnosed patients with low-risk embryonal rhabdomyosarcoma: a report from the Soft Tissue Sarcoma Committee of the Children's Oncology Group. J Clin Oncol. 2011 Apr 1;29(10):1312-8. [https://doi.org/10.1200/JCO.2010.30.4469 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3083999/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/21357783/ PubMed] [https://clinicaltrials.gov/study/NCT00002995 NCT00002995] |
| − | ==COG D9602 Subgroup B Clinical Group 1== | + | ==COG D9602 Subgroup B Clinical Group 1 protocol== |
| − | <div class="toccolours" style="background-color:# | + | <div class="toccolours" style="background-color:#ee6b6e"> |
===Regimen=== | ===Regimen=== | ||
{| class="wikitable sortable" style="width: 60%; text-align:center;" | {| class="wikitable sortable" style="width: 60%; text-align:center;" | ||
| Line 895: | Line 876: | ||
====Chemotherapy, Week 0==== | ====Chemotherapy, Week 0==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
*[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | *[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | ||
| − | ** | + | **1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1 |
*[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | *[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 2200 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on day 1 |
| − | ** | + | **1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
| − | ** | + | **Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
====Supportive Medications, Week 0==== | ====Supportive Medications, Week 0==== | ||
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 440 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **1 year old or older: 14.6 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **Younger than 1 year old: 7.2 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | *[[Filgrastim (Neupogen)]] 5 mcg/kg | + | *[[Filgrastim (Neupogen)]] 5 mcg/kg SC or IV (per institutional policy) once per day starting 24 hours after VAC completion and continued for 10 days or until ANC greater than 2000/μL |
====Chemotherapy, Week 1==== | ====Chemotherapy, Week 1==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 2==== | ====Chemotherapy, Week 2==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 3==== | ====Chemotherapy, Week 3==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
*[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | *[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | ||
| − | ** | + | **1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1 |
*[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | *[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 2200 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on day 1 |
| − | ** | + | **1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
| − | ** | + | **Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
====Supportive Medications, Week 3==== | ====Supportive Medications, Week 3==== | ||
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 440 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **1 year old or older: 14.6 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **Younger than 1 year old: 7.2 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | *[[Filgrastim (Neupogen)]] 5 mcg/kg | + | *[[Filgrastim (Neupogen)]] 5 mcg/kg SC or IV (per institutional policy) once per day starting 24 hours after VAC completion and continued for 10 days or until ANC greater than 2000/μL |
| − | |||
====Chemotherapy, Week 4==== | ====Chemotherapy, Week 4==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 5==== | ====Chemotherapy, Week 5==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 6==== | ====Chemotherapy, Week 6==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
*[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | *[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | ||
| − | ** | + | **1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1 |
*[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | *[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 2200 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on day 1 |
| − | ** | + | **1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
| − | ** | + | **Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
====Supportive Medications, Week 6==== | ====Supportive Medications, Week 6==== | ||
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 440 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **1 year old or older: 14.6 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **Younger than 1 year old: 7.2 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | *[[Filgrastim (Neupogen)]] 5 mcg/kg | + | *[[Filgrastim (Neupogen)]] 5 mcg/kg SC or IV (per institutional policy) once per day starting 24 hours after VAC completion and continued for 10 days or until ANC greater than 2000/μL |
====Chemotherapy, Week 7==== | ====Chemotherapy, Week 7==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 8==== | ====Chemotherapy, Week 8==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 9==== | ====Chemotherapy, Week 9==== | ||
*[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | *[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | ||
| − | ** | + | **1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1 |
*[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | *[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 2200 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on day 1 |
| − | ** | + | **1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
| − | ** | + | **Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
====Supportive Medications, Week 9==== | ====Supportive Medications, Week 9==== | ||
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 440 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **1 year old or older: 14.6 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **Younger than 1 year old: 7.2 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | *[[Filgrastim (Neupogen)]] 5 mcg/kg | + | *[[Filgrastim (Neupogen)]] 5 mcg/kg SC or IV (per institutional policy) once per day starting 24 hours after AC completion and continued for 10 days for 10 days or until ANC greater than 2000/μL |
| − | '''12-week cycle for 4 cycles | + | '''12-week cycle for 4 cycles; beginning on weeks 0, 12, 24, 36''' |
</div></div> | </div></div> | ||
===References=== | ===References=== | ||
| − | #'''IRSG D9602:''' Raney RB, Walterhouse DO, Meza JL, Andrassy RJ, Breneman JC, Crist WM, Maurer HM, Meyer WH, Parham DM, Anderson JR. Results of the Intergroup Rhabdomyosarcoma Study Group D9602 protocol, using vincristine and dactinomycin with or without cyclophosphamide and radiation therapy, for newly diagnosed patients with low-risk embryonal rhabdomyosarcoma: a report from the Soft Tissue Sarcoma Committee of the Children's Oncology Group. J Clin Oncol. 2011 Apr 1;29(10):1312-8. [https://doi.org/10.1200/JCO.2010.30.4469 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3083999/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/ | + | #'''IRSG D9602:''' Raney RB, Walterhouse DO, Meza JL, Andrassy RJ, Breneman JC, Crist WM, Maurer HM, Meyer WH, Parham DM, Anderson JR. Results of the Intergroup Rhabdomyosarcoma Study Group D9602 protocol, using vincristine and dactinomycin with or without cyclophosphamide and radiation therapy, for newly diagnosed patients with low-risk embryonal rhabdomyosarcoma: a report from the Soft Tissue Sarcoma Committee of the Children's Oncology Group. J Clin Oncol. 2011 Apr 1;29(10):1312-8. [https://doi.org/10.1200/JCO.2010.30.4469 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3083999/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/21357783/ PubMed] [https://clinicaltrials.gov/study/NCT00002995 NCT00002995] |
| − | ==COG D9602 Subgroup B Clinical Group 2== | + | ==COG D9602 Subgroup B Clinical Group 2 protocol== |
| − | <div class="toccolours" style="background-color:# | + | <div class="toccolours" style="background-color:#ee6b6e"> |
===Regimen=== | ===Regimen=== | ||
{| class="wikitable sortable" style="width: 60%; text-align:center;" | {| class="wikitable sortable" style="width: 60%; text-align:center;" | ||
| Line 1,013: | Line 993: | ||
====Chemotherapy, Week 0==== | ====Chemotherapy, Week 0==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
*[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | *[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | ||
| − | ** | + | **1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1 |
*[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | *[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 2200 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on day 1 |
| − | ** | + | **1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
| − | ** | + | **Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
====Supportive Medications, Week 0==== | ====Supportive Medications, Week 0==== | ||
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 440 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **1 year old or older: 14.6 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **Younger than 1 year old: 7.2 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | *[[Filgrastim (Neupogen)]] 5 mcg/kg | + | *[[Filgrastim (Neupogen)]] 5 mcg/kg SC or IV (per institutional policy) once per day starting 24 hours after VAC completion and continued for 10 days for 10 days or until ANC greater than 2000/μL |
====Chemotherapy, Week 1==== | ====Chemotherapy, Week 1==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 2==== | ====Chemotherapy, Week 2==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 3==== | ====Chemotherapy, Week 3==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
*[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | *[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | ||
| − | ** | + | **1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1 |
*[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | *[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 2200 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on day 1 |
| − | ** | + | **1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
| − | ** | + | **Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
====Supportive Medications, Week 3==== | ====Supportive Medications, Week 3==== | ||
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 440 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **1 year old or older: 14.6 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **Younger than 1 year old: 7.2 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | *[[Filgrastim (Neupogen)]] 5 mcg/kg | + | *[[Filgrastim (Neupogen)]] 5 mcg/kg SC or IV (per institutional policy) once per day starting 24 hours after VAC completion and continued for 10 days for 10 days or until ANC greater than 2000/μL |
====Radiotherapy, Week 3==== | ====Radiotherapy, Week 3==== | ||
| − | *[[External beam radiotherapy]] | + | *[[External beam radiotherapy]] 3600 cGy given once per day in 20 divided fractions |
====Chemotherapy, Week 4==== | ====Chemotherapy, Week 4==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 5==== | ====Chemotherapy, Week 5==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 6==== | ====Chemotherapy, Week 6==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
*[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | *[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 2200 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on day 1 |
| − | ** | + | **1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
| − | ** | + | **Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
====Supportive Medications, Week 6==== | ====Supportive Medications, Week 6==== | ||
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 440 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **1 year old or older: 14.6 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **Younger than 1 year old: 7.2 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | *[[Filgrastim (Neupogen)]] 5 mcg/kg | + | *[[Filgrastim (Neupogen)]] 5 mcg/kg SC or IV (per institutional policy) once per day starting 24 hours after VAC completion and continued for 10 days for 10 days or until ANC greater than 2000/μL |
====Chemotherapy, Week 7==== | ====Chemotherapy, Week 7==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 8==== | ====Chemotherapy, Week 8==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 9==== | ====Chemotherapy, Week 9==== | ||
*[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | *[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | ||
| − | ** | + | **1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1 |
*[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | *[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 2200 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on day 1 |
| − | ** | + | **1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
| − | ** | + | **Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
====Supportive Medications, Week 9==== | ====Supportive Medications, Week 9==== | ||
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 440 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **1 year old or older: 14.6 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **Younger than 1 year old: 7.2 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | *[[Filgrastim (Neupogen)]] 5 mcg/kg | + | *[[Filgrastim (Neupogen)]] 5 mcg/kg SC or IV (per institutional policy) once per day starting 24 hours after AC completion and continued for 10 days for 10 days or until ANC greater than 2000/μL |
| − | '''12-week cycle for 4 cycles | + | '''12-week cycle for 4 cycles; beginning on weeks 0, 12, 24, 36''' |
</div></div> | </div></div> | ||
===References=== | ===References=== | ||
| − | #'''IRSG D9602:''' Raney RB, Walterhouse DO, Meza JL, Andrassy RJ, Breneman JC, Crist WM, Maurer HM, Meyer WH, Parham DM, Anderson JR. Results of the Intergroup Rhabdomyosarcoma Study Group D9602 protocol, using vincristine and dactinomycin with or without cyclophosphamide and radiation therapy, for newly diagnosed patients with low-risk embryonal rhabdomyosarcoma: a report from the Soft Tissue Sarcoma Committee of the Children's Oncology Group. J Clin Oncol. 2011 Apr 1;29(10):1312-8. [https://doi.org/10.1200/JCO.2010.30.4469 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3083999/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/ | + | #'''IRSG D9602:''' Raney RB, Walterhouse DO, Meza JL, Andrassy RJ, Breneman JC, Crist WM, Maurer HM, Meyer WH, Parham DM, Anderson JR. Results of the Intergroup Rhabdomyosarcoma Study Group D9602 protocol, using vincristine and dactinomycin with or without cyclophosphamide and radiation therapy, for newly diagnosed patients with low-risk embryonal rhabdomyosarcoma: a report from the Soft Tissue Sarcoma Committee of the Children's Oncology Group. J Clin Oncol. 2011 Apr 1;29(10):1312-8. [https://doi.org/10.1200/JCO.2010.30.4469 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3083999/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/21357783/ PubMed] [https://clinicaltrials.gov/study/NCT00002995 NCT00002995] |
| − | ==COG D9602 Subgroup B Clinical Group 3== | + | ==COG D9602 Subgroup B Clinical Group 3 protocol== |
| − | <div class="toccolours" style="background-color:# | + | <div class="toccolours" style="background-color:#ee6b6e"> |
===Regimen=== | ===Regimen=== | ||
{| class="wikitable sortable" style="width: 60%; text-align:center;" | {| class="wikitable sortable" style="width: 60%; text-align:center;" | ||
| Line 1,129: | Line 1,109: | ||
====Chemotherapy, Week 0==== | ====Chemotherapy, Week 0==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
*[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | *[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | ||
| − | ** | + | **1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1 |
*[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | *[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 2200 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on day 1 |
| − | ** | + | **1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
| − | ** | + | **Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
====Supportive Medications, Week 0==== | ====Supportive Medications, Week 0==== | ||
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 440 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **1 year old or older: 14.6 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **Younger than 1 year old: 7.2 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | *[[Filgrastim (Neupogen)]] 5 mcg/kg | + | *[[Filgrastim (Neupogen)]] 5 mcg/kg SC or IV (per institutional policy) once per day starting 24 hours after VAC completion and continued for 10 days for 10 days or until ANC greater than 2000/μL |
====Chemotherapy, Week 1==== | ====Chemotherapy, Week 1==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 2==== | ====Chemotherapy, Week 2==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 3==== | ====Chemotherapy, Week 3==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
*[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | *[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | ||
| − | ** | + | **1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1 |
*[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | *[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 2200 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on day 1 |
| − | ** | + | **1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
| − | ** | + | **Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
====Supportive Medications, Week 3==== | ====Supportive Medications, Week 3==== | ||
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 440 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **1 year old or older: 14.6 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **Younger than 1 year old: 7.2 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | *[[Filgrastim (Neupogen)]] 5 mcg/kg | + | *[[Filgrastim (Neupogen)]] 5 mcg/kg SC or IV (per institutional policy) once per day starting 24 hours after VAC completion and continued for 10 days or until ANC greater than 2000/μL |
====Radiotherapy, Week 3==== | ====Radiotherapy, Week 3==== | ||
| − | *[[External beam radiotherapy]] | + | *[[External beam radiotherapy]] 4500 cGy given once per day in 25 divided fractions |
====Chemotherapy, Week 4==== | ====Chemotherapy, Week 4==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 5==== | ====Chemotherapy, Week 5==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 6==== | ====Chemotherapy, Week 6==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
*[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | *[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 2200 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on day 1 |
| − | ** | + | **1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
| − | ** | + | **Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
====Supportive Medications, Week 6==== | ====Supportive Medications, Week 6==== | ||
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 440 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **1 year old or older: 14.6 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **Younger than 1 year old: 7.2 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | *[[Filgrastim (Neupogen)]] 5 mcg/kg | + | *[[Filgrastim (Neupogen)]] 5 mcg/kg SC or IV (per institutional policy) once per day starting 24 hours after VAC completion and continued for 10 days or until ANC greater than 2000/μL |
====Chemotherapy, Week 7==== | ====Chemotherapy, Week 7==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 8==== | ====Chemotherapy, Week 8==== | ||
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1 |
====Chemotherapy, Week 9==== | ====Chemotherapy, Week 9==== | ||
*[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | *[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | ||
| − | ** | + | **1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1 |
| − | ** | + | **Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1 |
*[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | *[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 2200 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on day 1 |
| − | ** | + | **1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
| − | ** | + | **Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1 |
====Supportive Medications, Week 9==== | ====Supportive Medications, Week 9==== | ||
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
| − | ** | + | **3 years old or older: 440 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **1 year old or older: 14.6 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | ** | + | **Younger than 1 year old: 7.2 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1 |
| − | *[[Filgrastim (Neupogen)]] 5 mcg/kg | + | *[[Filgrastim (Neupogen)]] 5 mcg/kg SC or IV (per institutional policy) once per day starting 24 hours after AC completion and continued for 10 days or until ANC greater than 2000/μL |
| − | '''12-week cycle for 4 cycles | + | '''12-week cycle for 4 cycles; beginning on weeks 0, 12, 24, 36''' |
</div></div> | </div></div> | ||
===References=== | ===References=== | ||
| − | #'''IRSG D9602:''' Raney RB, Walterhouse DO, Meza JL, Andrassy RJ, Breneman JC, Crist WM, Maurer HM, Meyer WH, Parham DM, Anderson JR. Results of the Intergroup Rhabdomyosarcoma Study Group D9602 protocol, using vincristine and dactinomycin with or without cyclophosphamide and radiation therapy, for newly diagnosed patients with low-risk embryonal rhabdomyosarcoma: a report from the Soft Tissue Sarcoma Committee of the Children's Oncology Group. J Clin Oncol. 2011 Apr 1;29(10):1312-8. [https://doi.org/10.1200/JCO.2010.30.4469 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3083999/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/ | + | #'''IRSG D9602:''' Raney RB, Walterhouse DO, Meza JL, Andrassy RJ, Breneman JC, Crist WM, Maurer HM, Meyer WH, Parham DM, Anderson JR. Results of the Intergroup Rhabdomyosarcoma Study Group D9602 protocol, using vincristine and dactinomycin with or without cyclophosphamide and radiation therapy, for newly diagnosed patients with low-risk embryonal rhabdomyosarcoma: a report from the Soft Tissue Sarcoma Committee of the Children's Oncology Group. J Clin Oncol. 2011 Apr 1;29(10):1312-8. [https://doi.org/10.1200/JCO.2010.30.4469 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3083999/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/21357783/ PubMed] [https://clinicaltrials.gov/study/NCT00002995 NCT00002995] |
[[Category:Bone sarcomas]] | [[Category:Bone sarcomas]] | ||
[[Category:Historical regimens]] | [[Category:Historical regimens]] | ||
[[Category:Disease-specific pages]] | [[Category:Disease-specific pages]] | ||
[[Category:Pediatric solid tumors]] | [[Category:Pediatric solid tumors]] | ||
Latest revision as of 11:21, 13 May 2024
The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. Is there a regimen missing from this list? See the pediatric rhabdomyosarcoma page for current regimens.
1 regimens on this page
1 variants on this page
|
Unstratified, all lines of therapy
Dactinomycin monotherapy
References
- Pinkel D. Actinomycin D in childhood cancer; a preliminary report. Pediatrics. 1959 Feb;23(2):342-7. link to original article PubMed
High-risk, all lines of therapy
COG D9802 VCPT Alternating with VAC Arm
| Study | Dates of enrollment | Evidence |
|---|---|---|
| Pappo et al. 2007 (COG D9802) | 1999-09 to 2000-11 | Phase 2 |
Irinotecan window
Chemotherapy, Week 0 (VCPT)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Irinotecan (Camptosar) 50 mg/m2 (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 to 5, given after vincristine on day 1
Chemotherapy, Week 1 (VCPT)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Irinotecan (Camptosar) 50 mg/m2 (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 to 5, given after vincristine on day 1
Chemotherapy, Week 2 Off Chemo
Chemotherapy, Week 3 (VCPT)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Irinotecan (Camptosar) 50 mg/m2 (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 to 5, given after vincristine on day 1
Chemotherapy, Week 4 (VCPT)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Irinotecan (Camptosar) 50 mg/m2 (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 to 5, given after vincristine on day 1
Evaluation during week 5, followed by:
Induction
Chemotherapy, Week 6 (VAC)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- 1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- 3 years old or older: 2200 mg/m2 IV over 30 to 60 minutes once per day on day 1
- 1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
Supportive Medications, Week 6
- Mesna (Mesnex) by the following age-based criteria:
- 3 years old or older: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- 1 year old or older: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- Younger than 1 year old: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
Chemotherapy, Week 7 (Vincristine)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 8 (Vincristine)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 9 (VCPT)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Irinotecan (Camptosar) 50 mg/m2 (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 to 5, given after vincristine on day 1
Chemotherapy, Week 10 (VCPT)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Irinotecan (Camptosar) 50 mg/m2 (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 to 5, given after vincristine on day 1
Chemotherapy, Week 11 (Vincristine)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 12 (VAC)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- 1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- 3 years old or older: 2200 mg/m2 IV over 30 to 60 minutes once per day on day 1
- 1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
Supportive Medications, Week 12
- Mesna (Mesnex) by the following age-based criteria:
- 3 years old or older: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- 1 year old or older: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- Younger than 1 year old: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
Chemotherapy, Week 13 (Vincristine)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Evaluation during week 14, followed by:
Chemotherapy, Week 15 (Vincristine)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 16 (VC)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- 3 years old or older: 2200 mg/m2 IV over 30 to 60 minutes once per day on day 1
- 1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
Supportive Medications, Week 16
- Mesna (Mesnex) by the following age-based criteria:
- 3 years old or older: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- 1 year old or older: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- Younger than 1 year old: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
Chemotherapy, Week 17 (Vincristine)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 18 (Vincristine)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 19 (VC)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- 3 years old or older: 2200 mg/m2 IV over 30 to 60 minutes once per day on day 1
- 1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
Supportive Medications, Week 19
- Mesna (Mesnex) by the following age-based criteria:
- 3 years old or older: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- 1 year old or older: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- Younger than 1 year old: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
Chemotherapy, Week 20 through 22 Off Chemo
Chemotherapy, Week 23 (VAC)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- 1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- 3 years old or older: 2200 mg/m2 IV over 30 to 60 minutes once per day on day 1
- 1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
Supportive Medications, Week 23
- Mesna (Mesnex) by the following age-based criteria:
- 3 years old or older: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- 1 year old or older: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- Younger than 1 year old: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
Chemotherapy, Week 24 (Vincristine)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 25 (Eval/Vincristine)
- Evaluation Week
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Continuation
Chemotherapy, Week 26 (VCPT)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Irinotecan (Camptosar) 50 mg/m2 (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 to 5, given after vincristine on day 1
Chemotherapy, Week 27 (VCPT)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Irinotecan (Camptosar) 50 mg/m2 (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 to 5, given after vincristine on day 1
Chemotherapy, Week 28 Off Chemo
Chemotherapy, Week 29 (VAC)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- 1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- 3 years old or older: 2200 mg/m2 IV over 30 to 60 minutes once per day on day 1
- 1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
Supportive Medications, Week 29
- Mesna (Mesnex) by the following age-based criteria:
- 3 years old or older: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- 1 year old or older: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- Younger than 1 year old: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
Chemotherapy, Week 30 through 31 Off Chemo
Chemotherapy, Week 32 (VCPT)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Irinotecan (Camptosar) 50 mg/m2 (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 to 5, given after vincristine on day 1
Chemotherapy, Week 33 (VCPT)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Irinotecan (Camptosar) 50 mg/m2 (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 to 5, given after vincristine on day 1
Chemotherapy, Week 34 (Vincristine)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 35 (VAC)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- 1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- 3 years old or older: 2200 mg/m2 IV over 30 to 60 minutes once per day on day 1
- 1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
Supportive Medications, Week 35
- Mesna (Mesnex) by the following age-based criteria:
- 3 years old or older: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- 1 year old or older: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- Younger than 1 year old: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
Chemotherapy, Week 36 through 37 Off Chemo
Chemotherapy, Week 38 (VCPT)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Irinotecan (Camptosar) 50 mg/m2 (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 to 5, given after vincristine on day 1
Chemotherapy, Week 39 (VCPT)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Irinotecan (Camptosar) 50 mg/m2 (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 to 5, given after vincristine on day 1
Chemotherapy, Week 40 Off Chemo
Chemotherapy, Week 41 (VAC)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- 1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- 3 years old or older: 2200 mg/m2 IV over 30 to 60 minutes once per day on day 1
- 1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
Supportive Medications, Week 41
- Mesna (Mesnex) by the following age-based criteria:
- 3 years old or older: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- 1 year old or older: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- Younger than 1 year old: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
Evaluation during week 44
References
- COG D9802: Pappo AS, Lyden E, Breitfeld P, Donaldson SS, Wiener E, Parham D, Crews KR, Houghton P, Meyer WH. Two Consecutive Phase II Window Trials of Irinotecan Alone or in Combination With vincristine for the Treatment of Metastatic Rhabdomyosarcoma: The Children's Oncology Group. J Clin Oncol. 2007 Feb 1;25(4):362-9. link to original article PubMed NCT00003955
COG D9802 VAC Alone Arm
| Study | Dates of enrollment | Evidence |
|---|---|---|
| Pappo et al. 2007 (COG D9802) | 1999-09 to 2000-11 | Phase 2 |
Irinotecan window
Chemotherapy, Week 0 (VCPT)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Irinotecan (Camptosar) 50 mg/m2 (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 to 5, given after vincristine on day 1
Chemotherapy, Week 1 (VCPT)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Irinotecan (Camptosar) 50 mg/m2 (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 to 5, given after vincristine on day 1
Chemotherapy, Week 2 Off Chemo
Chemotherapy, Week 3 (VCPT)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Irinotecan (Camptosar) 50 mg/m2 (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 to 5, given after vincristine on day 1
Chemotherapy, Week 4 (VCPT)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Irinotecan (Camptosar) 50 mg/m2 (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 to 5, given after vincristine on day 1
Evaluation during week 5, followed by:
Induction
Chemotherapy, Week 6 (VAC)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- 1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- 3 years old or older: 2200 mg/m2 IV over 30 to 60 minutes once per day on day 1
- 1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
Supportive Medications, Week 6
- Mesna (Mesnex) by the following age-based criteria:
- 3 years old or older: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- 1 year old or older: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- Younger than 1 year old: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
Chemotherapy, Week 7 (Vincristine)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 8 (Vincristine)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 9 (VCPT)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Irinotecan (Camptosar) 50 mg/m2 (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 to 5, given after vincristine on day 1
Chemotherapy, Week 10 (VCPT)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Irinotecan (Camptosar) 50 mg/m2 (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 to 5, given after vincristine on day 1
Chemotherapy, Week 11 (Vincristine)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 12 (VAC)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- 1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- 3 years old or older: 2200 mg/m2 IV over 30 to 60 minutes once per day on day 1
- 1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
Supportive Medications, Week 12
- Mesna (Mesnex) by the following age-based criteria:
- 3 years old or older: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- 1 year old or older: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- Younger than 1 year old: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
Chemotherapy, Week 13 (Vincristine)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Evaluation during week 14, followed by:
Chemotherapy, Week 15 (Vincristine)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 16 (VC)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- 3 years old or older: 2200 mg/m2 IV over 30 to 60 minutes once per day on day 1
- 1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
Supportive Medications, Week 16
- Mesna (Mesnex) by the following age-based criteria:
- 3 years old or older: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- 1 year old or older: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- Younger than 1 year old: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
Chemotherapy, Week 17 (Vincristine)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 18 (Vincristine)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 19 (VC)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- 3 years old or older: 2200 mg/m2 IV over 30 to 60 minutes once per day on day 1
- 1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
Supportive Medications, Week 19
- Mesna (Mesnex) by the following age-based criteria:
- 3 years old or older: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- 1 year old or older: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- Younger than 1 year old: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
Chemotherapy, Week 20 through 22 Off Chemo
Chemotherapy, Week 23 (VAC)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- 1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- 3 years old or older: 2200 mg/m2 IV over 30 to 60 minutes once per day on day 1
- 1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
Supportive Medications, Week 23
- Mesna (Mesnex) by the following age-based criteria:
- 3 years old or older: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- 1 year old or older: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- Younger than 1 year old: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
Chemotherapy, Week 24 (Vincristine)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 25 (Evaluation/Vincristine)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Continuation
Chemotherapy, Week 26 (VAC)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- 1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- 3 years old or older: 2200 mg/m2 IV over 30 to 60 minutes once per day on day 1
- 1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
Supportive Medications, Week 26
- Mesna (Mesnex) by the following age-based criteria:
- 3 years old or older: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- 1 year old or older: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- Younger than 1 year old: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
Chemotherapy, Week 27 (VCR)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 28 Off Chemo
Chemotherapy, Week 29 (VAC)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- 1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- 3 years old or older: 2200 mg/m2 IV over 30 to 60 minutes once per day on day 1
- 1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
Supportive Medications, Week 29
- Mesna (Mesnex) by the following age-based criteria:
- 3 years old or older: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- 1 year old or older: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- Younger than 1 year old: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
Chemotherapy, Week 30 through 31 Off Chemo
Chemotherapy, Week 32 (VAC)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- 1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- 3 years old or older: 2200 mg/m2 IV over 30 to 60 minutes once per day on day 1
- 1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
Supportive Medications, Week 32
- Mesna (Mesnex) by the following age-based criteria:
- 3 years old or older: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- 1 year old or older: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- Younger than 1 year old: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
Chemotherapy, Week 33 (VCR)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 34 (Vincristine)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 35 (VAC)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- 1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- 3 years old or older: 2200 mg/m2 IV over 30 to 60 minutes once per day on day 1
- 1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
Supportive Medications, Week 35
- Mesna (Mesnex) by the following age-based criteria:
- 3 years old or older: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- 1 year old or older: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- Younger than 1 year old: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
Chemotherapy, Week 36 through 37 Off Chemo
Chemotherapy, Week 38 (VAC)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- 1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- 3 years old or older: 2200 mg/m2 IV over 30 to 60 minutes once per day on day 1
- 1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
Supportive Medications, Week 38
- Mesna (Mesnex) by the following age-based criteria:
- 3 years old or older: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- 1 year old or older: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- Younger than 1 year old: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
Chemotherapy, Week 39 through 40 Off Chemo
Chemotherapy, Week 41 (VAC)
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- 1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- 3 years old or older: 2200 mg/m2 IV over 30 to 60 minutes once per day on day 1
- 1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
Supportive Medications, Week 41
- Mesna (Mesnex) by the following age-based criteria:
- 3 years old or older: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- 1 year old or older: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- Younger than 1 year old: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
Evaluation during week 44
References
- COG D9802: Pappo AS, Lyden E, Breitfeld P, Donaldson SS, Wiener E, Parham D, Crews KR, Houghton P, Meyer WH. Two Consecutive Phase II Window Trials of Irinotecan Alone or in Combination With vincristine for the Treatment of Metastatic Rhabdomyosarcoma: The Children's Oncology Group. J Clin Oncol. 2007 Feb 1;25(4):362-9. link to original article PubMed NCT00003955
Low-risk, all lines of therapy
COG D9602 Subgroup A Clinical Group 1 protocol
Regimen
| Study | Dates of enrollment | Evidence |
|---|---|---|
| Raney et al. 2011 (IRSG D9602) | 1997-09-01 to 2004-09-17 | Phase 2 |
Note: evaluation is performed at the end of each 12-week cycle.
Chemotherapy, Week 0
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- 1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
Chemotherapy, Week 1
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 2
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 3
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- 1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
Chemotherapy, Week 4
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 5
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 6
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- 1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
Chemotherapy, Week 7
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 8
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 9
- Dactinomycin (Cosmegen) by the following age-based criteria:
- 1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
12-week cycle for 4 cycles; beginning on weeks 0, 12, 24, 36
References
- IRSG D9602: Raney RB, Walterhouse DO, Meza JL, Andrassy RJ, Breneman JC, Crist WM, Maurer HM, Meyer WH, Parham DM, Anderson JR. Results of the Intergroup Rhabdomyosarcoma Study Group D9602 protocol, using vincristine and dactinomycin with or without cyclophosphamide and radiation therapy, for newly diagnosed patients with low-risk embryonal rhabdomyosarcoma: a report from the Soft Tissue Sarcoma Committee of the Children's Oncology Group. J Clin Oncol. 2011 Apr 1;29(10):1312-8. link to original article link to PMC article PubMed NCT00002995
COG D9602 Subgroup A Clinical Group 2 protocol
Regimen
| Study | Dates of enrollment | Evidence |
|---|---|---|
| Raney et al. 2011 (IRSG D9602) | 1997-09-01 to 2004-09-17 | Phase 2 |
Note: Evaluation occurs at the end of each 12-week cycle.
Chemotherapy, Week 0
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- 1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
Chemotherapy, Week 1
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 2
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 3
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- 1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
Radiotherapy, Week 3
- External beam radiotherapy 3600 cGy given once per day in 20 divided fractions
Chemotherapy, Week 4
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 5
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 6
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 7
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 8
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 9
- Dactinomycin (Cosmegen) by the following age-based criteria:
- 1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
12-week cycle for 4 cycles; beginning on weeks 0, 12, 24, 36
References
- IRSG D9602: Raney RB, Walterhouse DO, Meza JL, Andrassy RJ, Breneman JC, Crist WM, Maurer HM, Meyer WH, Parham DM, Anderson JR. Results of the Intergroup Rhabdomyosarcoma Study Group D9602 protocol, using vincristine and dactinomycin with or without cyclophosphamide and radiation therapy, for newly diagnosed patients with low-risk embryonal rhabdomyosarcoma: a report from the Soft Tissue Sarcoma Committee of the Children's Oncology Group. J Clin Oncol. 2011 Apr 1;29(10):1312-8. link to original article link to PMC article PubMed NCT00002995
COG D9602 Subgroup A Clinical Group 3 protocol
Regimen
| Study | Dates of enrollment | Evidence |
|---|---|---|
| Raney et al. 2011 (IRSG D9602) | 1997-09-01 to 2004-09-17 | Phase 2 |
Note: Evaluation occurs at the end of each 12-week cycle.
Chemotherapy, Week 0
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- 1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
Chemotherapy, Week 1
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 2
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 3
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- 1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
Radiotherapy, Week 3
- External beam radiotherapy 4500 cGy given once per day in 25 divided fractions
Chemotherapy, Week 4
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 5
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 6
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 7
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 8
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 9
- Dactinomycin (Cosmegen) by the following age-based criteria:
- 1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
12-week cycle for 4 cycles; beginning on weeks 0, 12, 24, 36
References
- IRSG D9602: Raney RB, Walterhouse DO, Meza JL, Andrassy RJ, Breneman JC, Crist WM, Maurer HM, Meyer WH, Parham DM, Anderson JR. Results of the Intergroup Rhabdomyosarcoma Study Group D9602 protocol, using vincristine and dactinomycin with or without cyclophosphamide and radiation therapy, for newly diagnosed patients with low-risk embryonal rhabdomyosarcoma: a report from the Soft Tissue Sarcoma Committee of the Children's Oncology Group. J Clin Oncol. 2011 Apr 1;29(10):1312-8. link to original article link to PMC article PubMed NCT00002995
COG D9602 Subgroup B Clinical Group 1 protocol
Regimen
| Study | Dates of enrollment | Evidence |
|---|---|---|
| Raney et al. 2011 (IRSG D9602) | 1997-09-01 to 2004-09-17 | Phase 2 |
Note: Evaluation occurs at the end of each 12-week cycle.
Chemotherapy, Week 0
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- 1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- 3 years old or older: 2200 mg/m2 IV over 30 to 60 minutes once per day on day 1
- 1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
Supportive Medications, Week 0
- Mesna (Mesnex) by the following age-based criteria:
- 3 years old or older: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- 1 year old or older: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- Younger than 1 year old: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- Filgrastim (Neupogen) 5 mcg/kg SC or IV (per institutional policy) once per day starting 24 hours after VAC completion and continued for 10 days or until ANC greater than 2000/μL
Chemotherapy, Week 1
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 2
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 3
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- 1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- 3 years old or older: 2200 mg/m2 IV over 30 to 60 minutes once per day on day 1
- 1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
Supportive Medications, Week 3
- Mesna (Mesnex) by the following age-based criteria:
- 3 years old or older: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- 1 year old or older: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- Younger than 1 year old: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- Filgrastim (Neupogen) 5 mcg/kg SC or IV (per institutional policy) once per day starting 24 hours after VAC completion and continued for 10 days or until ANC greater than 2000/μL
Chemotherapy, Week 4
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 5
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 6
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- 1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- 3 years old or older: 2200 mg/m2 IV over 30 to 60 minutes once per day on day 1
- 1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
Supportive Medications, Week 6
- Mesna (Mesnex) by the following age-based criteria:
- 3 years old or older: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- 1 year old or older: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- Younger than 1 year old: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- Filgrastim (Neupogen) 5 mcg/kg SC or IV (per institutional policy) once per day starting 24 hours after VAC completion and continued for 10 days or until ANC greater than 2000/μL
Chemotherapy, Week 7
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 8
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 9
- Dactinomycin (Cosmegen) by the following age-based criteria:
- 1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- 3 years old or older: 2200 mg/m2 IV over 30 to 60 minutes once per day on day 1
- 1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
Supportive Medications, Week 9
- Mesna (Mesnex) by the following age-based criteria:
- 3 years old or older: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- 1 year old or older: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- Younger than 1 year old: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- Filgrastim (Neupogen) 5 mcg/kg SC or IV (per institutional policy) once per day starting 24 hours after AC completion and continued for 10 days for 10 days or until ANC greater than 2000/μL
12-week cycle for 4 cycles; beginning on weeks 0, 12, 24, 36
References
- IRSG D9602: Raney RB, Walterhouse DO, Meza JL, Andrassy RJ, Breneman JC, Crist WM, Maurer HM, Meyer WH, Parham DM, Anderson JR. Results of the Intergroup Rhabdomyosarcoma Study Group D9602 protocol, using vincristine and dactinomycin with or without cyclophosphamide and radiation therapy, for newly diagnosed patients with low-risk embryonal rhabdomyosarcoma: a report from the Soft Tissue Sarcoma Committee of the Children's Oncology Group. J Clin Oncol. 2011 Apr 1;29(10):1312-8. link to original article link to PMC article PubMed NCT00002995
COG D9602 Subgroup B Clinical Group 2 protocol
Regimen
| Study | Dates of enrollment | Evidence |
|---|---|---|
| Raney et al. 2011 (IRSG D9602) | 1997-09-01 to 2004-09-17 | Phase 2 |
Note: Evaluation occurs at the end of each 12-week cycle.
Chemotherapy, Week 0
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- 1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- 3 years old or older: 2200 mg/m2 IV over 30 to 60 minutes once per day on day 1
- 1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
Supportive Medications, Week 0
- Mesna (Mesnex) by the following age-based criteria:
- 3 years old or older: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- 1 year old or older: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- Younger than 1 year old: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- Filgrastim (Neupogen) 5 mcg/kg SC or IV (per institutional policy) once per day starting 24 hours after VAC completion and continued for 10 days for 10 days or until ANC greater than 2000/μL
Chemotherapy, Week 1
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 2
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 3
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- 1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- 3 years old or older: 2200 mg/m2 IV over 30 to 60 minutes once per day on day 1
- 1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
Supportive Medications, Week 3
- Mesna (Mesnex) by the following age-based criteria:
- 3 years old or older: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- 1 year old or older: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- Younger than 1 year old: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- Filgrastim (Neupogen) 5 mcg/kg SC or IV (per institutional policy) once per day starting 24 hours after VAC completion and continued for 10 days for 10 days or until ANC greater than 2000/μL
Radiotherapy, Week 3
- External beam radiotherapy 3600 cGy given once per day in 20 divided fractions
Chemotherapy, Week 4
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 5
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 6
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- 3 years old or older: 2200 mg/m2 IV over 30 to 60 minutes once per day on day 1
- 1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
Supportive Medications, Week 6
- Mesna (Mesnex) by the following age-based criteria:
- 3 years old or older: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- 1 year old or older: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- Younger than 1 year old: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- Filgrastim (Neupogen) 5 mcg/kg SC or IV (per institutional policy) once per day starting 24 hours after VAC completion and continued for 10 days for 10 days or until ANC greater than 2000/μL
Chemotherapy, Week 7
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 8
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 9
- Dactinomycin (Cosmegen) by the following age-based criteria:
- 1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- 3 years old or older: 2200 mg/m2 IV over 30 to 60 minutes once per day on day 1
- 1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
Supportive Medications, Week 9
- Mesna (Mesnex) by the following age-based criteria:
- 3 years old or older: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- 1 year old or older: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- Younger than 1 year old: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- Filgrastim (Neupogen) 5 mcg/kg SC or IV (per institutional policy) once per day starting 24 hours after AC completion and continued for 10 days for 10 days or until ANC greater than 2000/μL
12-week cycle for 4 cycles; beginning on weeks 0, 12, 24, 36
References
- IRSG D9602: Raney RB, Walterhouse DO, Meza JL, Andrassy RJ, Breneman JC, Crist WM, Maurer HM, Meyer WH, Parham DM, Anderson JR. Results of the Intergroup Rhabdomyosarcoma Study Group D9602 protocol, using vincristine and dactinomycin with or without cyclophosphamide and radiation therapy, for newly diagnosed patients with low-risk embryonal rhabdomyosarcoma: a report from the Soft Tissue Sarcoma Committee of the Children's Oncology Group. J Clin Oncol. 2011 Apr 1;29(10):1312-8. link to original article link to PMC article PubMed NCT00002995
COG D9602 Subgroup B Clinical Group 3 protocol
Regimen
| Study | Dates of enrollment | Evidence |
|---|---|---|
| Raney et al. 2011 (IRSG D9602) | 1997-09-01 to 2004-09-17 | Phase 2 |
Note: Evaluation occurs at the end of each 12-week cycle.
Chemotherapy, Week 0
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- 1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- 3 years old or older: 2200 mg/m2 IV over 30 to 60 minutes once per day on day 1
- 1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
Supportive Medications, Week 0
- Mesna (Mesnex) by the following age-based criteria:
- 3 years old or older: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- 1 year old or older: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- Younger than 1 year old: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- Filgrastim (Neupogen) 5 mcg/kg SC or IV (per institutional policy) once per day starting 24 hours after VAC completion and continued for 10 days for 10 days or until ANC greater than 2000/μL
Chemotherapy, Week 1
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 2
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 3
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- 1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- 3 years old or older: 2200 mg/m2 IV over 30 to 60 minutes once per day on day 1
- 1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
Supportive Medications, Week 3
- Mesna (Mesnex) by the following age-based criteria:
- 3 years old or older: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- 1 year old or older: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- Younger than 1 year old: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- Filgrastim (Neupogen) 5 mcg/kg SC or IV (per institutional policy) once per day starting 24 hours after VAC completion and continued for 10 days or until ANC greater than 2000/μL
Radiotherapy, Week 3
- External beam radiotherapy 4500 cGy given once per day in 25 divided fractions
Chemotherapy, Week 4
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 5
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 6
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- 3 years old or older: 2200 mg/m2 IV over 30 to 60 minutes once per day on day 1
- 1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
Supportive Medications, Week 6
- Mesna (Mesnex) by the following age-based criteria:
- 3 years old or older: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- 1 year old or older: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- Younger than 1 year old: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- Filgrastim (Neupogen) 5 mcg/kg SC or IV (per institutional policy) once per day starting 24 hours after VAC completion and continued for 10 days or until ANC greater than 2000/μL
Chemotherapy, Week 7
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 8
- Vincristine (Oncovin) by the following age-based criteria:
- 3 years old or older: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- 1 up to 3 years old: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Younger than 1 year old: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 9
- Dactinomycin (Cosmegen) by the following age-based criteria:
- 1 year old or older: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Younger than 1 year old: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- 3 years old or older: 2200 mg/m2 IV over 30 to 60 minutes once per day on day 1
- 1 year old or older: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Younger than 1 year old: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
Supportive Medications, Week 9
- Mesna (Mesnex) by the following age-based criteria:
- 3 years old or older: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- 1 year old or older: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- Younger than 1 year old: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each cyclophosphamide infusion on day 1
- Filgrastim (Neupogen) 5 mcg/kg SC or IV (per institutional policy) once per day starting 24 hours after AC completion and continued for 10 days or until ANC greater than 2000/μL
12-week cycle for 4 cycles; beginning on weeks 0, 12, 24, 36
References
- IRSG D9602: Raney RB, Walterhouse DO, Meza JL, Andrassy RJ, Breneman JC, Crist WM, Maurer HM, Meyer WH, Parham DM, Anderson JR. Results of the Intergroup Rhabdomyosarcoma Study Group D9602 protocol, using vincristine and dactinomycin with or without cyclophosphamide and radiation therapy, for newly diagnosed patients with low-risk embryonal rhabdomyosarcoma: a report from the Soft Tissue Sarcoma Committee of the Children's Oncology Group. J Clin Oncol. 2011 Apr 1;29(10):1312-8. link to original article link to PMC article PubMed NCT00002995