Difference between revisions of "Rhabdomyosarcoma, pediatric - historical"
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==COG D9602 Subgroup B Clinical Group 2== | ==COG D9602 Subgroup B Clinical Group 2== | ||
− | === | + | ===Regimen=== |
* Four 12-week cycles beginning on weeks 0, 12, 24, 36 | * Four 12-week cycles beginning on weeks 0, 12, 24, 36 | ||
− | ====Week 0==== | + | ====Chemotherapy, Week 0==== |
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
**Age ≥ 3 years: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 | **Age ≥ 3 years: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 | ||
Line 918: | Line 918: | ||
**Age < 1 year: 7.2 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each [[Cyclophosphamide (Cytoxan)]] infusion on day 1 | **Age < 1 year: 7.2 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each [[Cyclophosphamide (Cytoxan)]] infusion on day 1 | ||
*[[Filgrastim (Neupogen)]] 5 μg/kg SubQ or IV (per institutional policy) once daily starting 24 hours after VAC completion and continued once daily for 10 days or until ANC > 2000/μL | *[[Filgrastim (Neupogen)]] 5 μg/kg SubQ or IV (per institutional policy) once daily starting 24 hours after VAC completion and continued once daily for 10 days or until ANC > 2000/μL | ||
− | ====Week 1==== | + | ====Chemotherapy, Week 1==== |
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
**Age ≥ 3 years: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 | **Age ≥ 3 years: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 | ||
**Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 | **Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 | ||
**Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1 | **Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1 | ||
− | ====Week 2==== | + | ====Chemotherapy, Week 2==== |
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
**Age ≥ 3 years: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 | **Age ≥ 3 years: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 | ||
**Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 | **Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 | ||
**Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1 | **Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1 | ||
− | ====Week 3==== | + | ====Chemotherapy, Week 3==== |
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
**Age ≥ 3 years: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 | **Age ≥ 3 years: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 | ||
Line 947: | Line 947: | ||
*[[External beam radiotherapy]] 36 Gy given once daily in 20 divided fractions | *[[External beam radiotherapy]] 36 Gy given once daily in 20 divided fractions | ||
− | ====Week 4==== | + | ====Chemotherapy, Week 4==== |
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
**Age ≥ 3 years: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 | **Age ≥ 3 years: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 | ||
**Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 | **Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 | ||
**Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1 | **Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1 | ||
− | ====Week 5==== | + | ====Chemotherapy, Week 5==== |
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
**Age ≥ 3 years: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 | **Age ≥ 3 years: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 | ||
**Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 | **Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 | ||
**Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1 | **Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1 | ||
− | ====Week 6==== | + | ====Chemotherapy, Week 6==== |
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
**Age ≥ 3 years: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 | **Age ≥ 3 years: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 | ||
Line 971: | Line 971: | ||
**Age < 1 year: 7.2 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each [[Cyclophosphamide (Cytoxan)]] infusion on day 1 | **Age < 1 year: 7.2 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each [[Cyclophosphamide (Cytoxan)]] infusion on day 1 | ||
*[[Filgrastim (Neupogen)]] 5 μg/kg SubQ or IV (per institutional policy) once daily starting 24 hours after VAC completion and continued once daily for 10 days or until ANC > 2000/μL | *[[Filgrastim (Neupogen)]] 5 μg/kg SubQ or IV (per institutional policy) once daily starting 24 hours after VAC completion and continued once daily for 10 days or until ANC > 2000/μL | ||
− | ====Week 7==== | + | ====Chemotherapy, Week 7==== |
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
**Age ≥ 3 years: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 | **Age ≥ 3 years: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 | ||
**Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 | **Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 | ||
**Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1 | **Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1 | ||
− | ====Week 8==== | + | ====Chemotherapy, Week 8==== |
*[[Vincristine (Oncovin)]] by the following age-based criteria: | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
**Age ≥ 3 years: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 | **Age ≥ 3 years: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 | ||
**Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 | **Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 | ||
**Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1 | **Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1 | ||
− | ====Week 9==== | + | ====Chemotherapy, Week 9==== |
*[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | *[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | ||
**Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1 | **Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1 | ||
Line 994: | Line 994: | ||
**Age < 1 year: 7.2 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each [[Cyclophosphamide (Cytoxan)]] infusion on day 1 | **Age < 1 year: 7.2 mg/m<sup>2</sup> IV infusion at hour 0, 4, and 8 from the start of each [[Cyclophosphamide (Cytoxan)]] infusion on day 1 | ||
*[[Filgrastim (Neupogen)]] 5 μg/kg SubQ or IV (per institutional policy) once daily starting 24 hours after AC completion and continued once daily for 10 days or until ANC > 2000/μL | *[[Filgrastim (Neupogen)]] 5 μg/kg SubQ or IV (per institutional policy) once daily starting 24 hours after AC completion and continued once daily for 10 days or until ANC > 2000/μL | ||
− | ====Week 10 and 11 Off Chemo==== | + | ====Chemotherapy, Week 10 and 11 Off Chemo==== |
− | ====Week 12 Evaluation==== | + | ====Chemotherapy, Week 12 Evaluation==== |
===References=== | ===References=== | ||
# '''COG D9602:''' Raney RB, Walterhouse DO, Meza JL, Andrassy RJ, Breneman JC, Crist WM, Maurer HM, 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. Journal of Clinical Oncology. 2011 Apr 1;29(10):1312-1318. [https://doi.org/10.1200/JCO.2010.30.4469 link to original article] [https://pubmed.ncbi.nlm.nih.gov/17264331/ PubMed] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3083999/ PMC Full Text] NCT00002995 | # '''COG D9602:''' Raney RB, Walterhouse DO, Meza JL, Andrassy RJ, Breneman JC, Crist WM, Maurer HM, 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. Journal of Clinical Oncology. 2011 Apr 1;29(10):1312-1318. [https://doi.org/10.1200/JCO.2010.30.4469 link to original article] [https://pubmed.ncbi.nlm.nih.gov/17264331/ PubMed] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3083999/ PMC Full Text] NCT00002995 | ||
+ | |||
==COG D9602 Subgroup B Clinical Group 3== | ==COG D9602 Subgroup B Clinical Group 3== | ||
Revision as of 14:43, 29 September 2022
The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. 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 NCCN Guidelines. Is there a regimen missing from this list? See the Rhabdomyosarcoma page for current regimens.
1 regimens on this page
1 variants on this page
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High Risk
COG D9802 VCPT Alternating with VAC Arm
Irinotecan Window
Week 0 (VCPT)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 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 through 5
- Irinotecan (Camptosar) to be given after Vincristine (Oncovin)
Week 1 (VCPT)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 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 through 5
- Irinotecan (Camptosar) to be given after Vincristine (Oncovin)
Week 2 Off Chemo
Week 3 (VCPT)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 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 through 5
- Irinotecan (Camptosar) to be given after Vincristine (Oncovin)
Week 4 (VCPT)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 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 through 5
- Irinotecan (Camptosar) to be given after Vincristine (Oncovin)
Week 5 Evaluation
Induction
Week 6 (VAC)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- Age ≥ 3 years: 2.2 g/m2 IV infusion over 30 to 60 minutes once per day on day 1
- Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age ≥ 1 year: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age < 1 year: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
Week 7 (Vincristine)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Week 8 (Vincristine)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Week 9 (VCPT)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 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 through 5
- Irinotecan (Camptosar) to be given after Vincristine (Oncovin)
Week 10 (VCPT)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 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 through 5
- Irinotecan (Camptosar) to be given after Vincristine (Oncovin)
Week 11 (Vincristine)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Week 12 (VAC)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- Age ≥ 3 years: 2.2 g/m2 IV infusion over 30 to 60 minutes once per day on day 1
- Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age ≥ 1 year: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age < 1 year: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
Week 13 (Vincristine)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Week 14 Evaluation
Week 15 (Vincristine)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Week 16 (VC)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- Age ≥ 3 years: 2.2 g/m2 IV infusion over 30 to 60 minutes once per day on day 1
- Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age ≥ 1 year: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age < 1 year: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
Week 17 (Vincristine)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Week 18 (Vincristine)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Week 19 (VC)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- Age ≥ 3 years: 2.2 g/m2 IV infusion over 30 to 60 minutes once per day on day 1
- Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age ≥ 1 year: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age < 1 year: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
Week 20 through 22 Off Chemo
Week 23 (VAC)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- Age ≥ 3 years: 2.2 g/m2 IV infusion over 30 to 60 minutes once per day on day 1
- Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age ≥ 1 year: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age < 1 year: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
Week 24 (Vincristine)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Week 25 (Eval/Vincristine)
- Evaluation Week
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Continuation
Week 26 (VCPT)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 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 through 5
- Irinotecan (Camptosar) to be given after Vincristine (Oncovin)
Week 27 (VCPT)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 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 through 5
- Irinotecan (Camptosar) to be given after Vincristine (Oncovin)
Week 28 Off Chemo
Week 29 (VAC)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- Age ≥ 3 years: 2.2 g/m2 IV infusion over 30 to 60 minutes once per day on day 1
- Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age ≥ 1 year: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age < 1 year: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
Week 30 through 31 Off Chemo
Week 32 (VCPT)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 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 through 5
- Irinotecan (Camptosar) to be given after Vincristine (Oncovin)
Week 33 (VCPT)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 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 through 5
- Irinotecan (Camptosar) to be given after Vincristine (Oncovin)
Week 34 (Vincristine)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Week 35 (VAC)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- Age ≥ 3 years: 2.2 g/m2 IV infusion over 30 to 60 minutes once per day on day 1
- Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age ≥ 1 year: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age < 1 year: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
Week 36 through 37 Off Chemo
Week 38 (VCPT)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 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 through 5
- Irinotecan (Camptosar) to be given after Vincristine (Oncovin)
Week 39 (VCPT)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 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 through 5
- Irinotecan (Camptosar) to be given after Vincristine (Oncovin)
Week 40 Off Chemo
Week 41 (VAC)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- Age ≥ 3 years: 2.2 g/m2 IV infusion over 30 to 60 minutes once per day on day 1
- Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age ≥ 1 year: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age < 1 year: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
Week 42 through 43 Off Chemo
Week 44 Evaluation
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. Journal of Clinical Oncology. 2007 Feb;25(4):362-369. link to original article PubMed NCT00003955
COG D9802 VAC Alone Arm
Irinotecan Window
Week 0 (VCPT)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 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 through 5
- Irinotecan (Camptosar) to be given after Vincristine (Oncovin)
Week 1 (VCPT)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 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 through 5
- Irinotecan (Camptosar) to be given after Vincristine (Oncovin)
Week 2 Off Chemo
Week 3 (VCPT)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 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 through 5
- Irinotecan (Camptosar) to be given after Vincristine (Oncovin)
Week 4 (VCPT)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 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 through 5
- Irinotecan (Camptosar) to be given after Vincristine (Oncovin)
Week 5 Evaluation
Induction
Week 6 (VAC)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- Age ≥ 3 years: 2.2 g/m2 IV infusion over 30 to 60 minutes once per day on day 1
- Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age ≥ 1 year: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age < 1 year: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
Week 7 (Vincristine)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Week 8 (Vincristine)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Week 9 (VCPT)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 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 through 5
- Irinotecan (Camptosar) to be given after Vincristine (Oncovin)
Week 10 (VCPT)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 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 through 5
- Irinotecan (Camptosar) to be given after Vincristine (Oncovin)
Week 11 (Vincristine)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Week 12 (VAC)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- Age ≥ 3 years: 2.2 g/m2 IV infusion over 30 to 60 minutes once per day on day 1
- Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age ≥ 1 year: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age < 1 year: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
Week 13 (Vincristine)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Week 14 Evaluation
Week 15 (Vincristine)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Week 16 (VC)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- Age ≥ 3 years: 2.2 g/m2 IV infusion over 30 to 60 minutes once per day on day 1
- Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age ≥ 1 year: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age < 1 year: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
Week 17 (Vincristine)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Week 18 (Vincristine)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Week 19 (VC)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- Age ≥ 3 years: 2.2 g/m2 IV infusion over 30 to 60 minutes once per day on day 1
- Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age ≥ 1 year: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age < 1 year: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
Week 20 through 22 Off Chemo
Week 23 (VAC)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- Age ≥ 3 years: 2.2 g/m2 IV infusion over 30 to 60 minutes once per day on day 1
- Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age ≥ 1 year: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age < 1 year: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
Week 24 (Vincristine)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Week 25 (Evaluation/Vincristine)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Continuation
Week 26 (VAC)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- Age ≥ 3 years: 2.2 g/m2 IV infusion over 30 to 60 minutes once per day on day 1
- Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age ≥ 1 year: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age < 1 year: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
Week 27 (VCR)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Week 28 Off Chemo
Week 29 (VAC)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- Age ≥ 3 years: 2.2 g/m2 IV infusion over 30 to 60 minutes once per day on day 1
- Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age ≥ 1 year: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age < 1 year: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
Week 30 through 31 Off Chemo
Week 32 (VAC)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- Age ≥ 3 years: 2.2 g/m2 IV infusion over 30 to 60 minutes once per day on day 1
- Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age ≥ 1 year: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age < 1 year: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
Week 33 (VCR)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Week 34 (Vincristine)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Week 35 (VAC)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- Age ≥ 3 years: 2.2 g/m2 IV infusion over 30 to 60 minutes once per day on day 1
- Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age ≥ 1 year: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age < 1 year: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
Week 36 through 37 Off Chemo
Week 38 (VAC)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- Age ≥ 3 years: 2.2 g/m2 IV infusion over 30 to 60 minutes once per day on day 1
- Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age ≥ 1 year: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age < 1 year: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
Week 39 through 40 Off Chemo
Week 41 (VAC)
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- Age ≥ 3 years: 2.2 g/m2 IV infusion over 30 to 60 minutes once per day on day 1
- Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age ≥ 1 year: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age < 1 year: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
Week 42 through 43 Off Chemo
Week 44 Evaluation
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. Journal of Clinical Oncology. 2007 Feb;25(4):362-369. link to original article PubMed NCT00003955
Low Risk
COG D9602 Subgroup A Clinical Group 1
Regimen
- Four 12-week cycles beginning on weeks 0, 12, 24, 36
Chemotherapy, Week 0
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Age < 1 year: 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:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 2
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 3
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- No External beam radiotherapy
Chemotherapy, Week 4
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 5
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 6
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Age < 1 year: 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:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 8
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 9
- Dactinomycin (Cosmegen) by the following age-based criteria:
- Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
Chemotherapy, Week 10 and 11 Off Chemo
Chemotherapy, Week 12 Evaluation
References
- COG D9602: Raney RB, Walterhouse DO, Meza JL, Andrassy RJ, Breneman JC, Crist WM, Maurer HM, 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. Journal of Clinical Oncology. 2011 Apr 1;29(10):1312-1318. link to original article PubMed PMC Full Text NCT00002995
COG D9602 Subgroup A Clinical Group 2
Regimen
- Four 12-week cycles beginning on weeks 0, 12, 24, 36
Chemotherapy, Week 0
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Age < 1 year: 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:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 2
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 3
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- External beam radiotherapy 36 Gy given once daily in 20 divided fractions
Chemotherapy, Week 4
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 5
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 6
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 7
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 8
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 9
- Dactinomycin (Cosmegen) by the following age-based criteria:
- Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
Chemotherapy, Week 10 and 11 Off Chemo
Chemotherapy, Week 12 Evaluation
References
- COG D9602: Raney RB, Walterhouse DO, Meza JL, Andrassy RJ, Breneman JC, Crist WM, Maurer HM, 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. Journal of Clinical Oncology. 2011 Apr 1;29(10):1312-1318. link to original article PubMed PMC Full Text NCT00002995
COG D9602 Subgroup A Clinical Group 3
Regimen
- Four 12-week cycles beginning on weeks 0, 12, 24, 36
Chemotherapy, Week 0
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Age < 1 year: 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:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 2
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 3
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- External beam radiotherapy 45 Gy given once daily in 25 divided fractions
Chemotherapy, Week 4
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 5
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 6
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 7
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 8
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 9
- Dactinomycin (Cosmegen) by the following age-based criteria:
- Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
Chemotherapy, Week 10 and 11 Off Chemo
Chemotherapy, Week 12 Evaluation
References
- COG D9602: Raney RB, Walterhouse DO, Meza JL, Andrassy RJ, Breneman JC, Crist WM, Maurer HM, 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. Journal of Clinical Oncology. 2011 Apr 1;29(10):1312-1318. link to original article PubMed PMC Full Text NCT00002995
COG D9602 Subgroup B Clinical Group 1
Regimen
- Four 12-week cycles beginning on weeks 0, 12, 24, 36
Chemotherapy, Week 0
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- Age ≥ 3 years: 2.2 g/m2 IV infusion over 30 to 60 minutes once per day on day 1
- Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age ≥ 1 year: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age < 1 year: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Filgrastim (Neupogen) 5 μg/kg SubQ or IV (per institutional policy) once daily starting 24 hours after VAC completion and continued once daily for 10 days or until ANC > 2000/μL
Chemotherapy, Week 1
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 2
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 3
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- Age ≥ 3 years: 2.2 g/m2 IV infusion over 30 to 60 minutes once per day on day 1
- Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age ≥ 1 year: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age < 1 year: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Filgrastim (Neupogen) 5 μg/kg SubQ or IV (per institutional policy) once daily starting 24 hours after VAC completion and continued once daily for 10 days or until ANC > 2000/μL
- No External beam radiotherapy
Chemotherapy, Week 4
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 5
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 6
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- Age ≥ 3 years: 2.2 g/m2 IV infusion over 30 to 60 minutes once per day on day 1
- Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age ≥ 1 year: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age < 1 year: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Filgrastim (Neupogen) 5 μg/kg SubQ or IV (per institutional policy) once daily starting 24 hours after VAC completion and continued once daily for 10 days or until ANC > 2000/μL
Chemotherapy, Week 7
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 8
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 9
- Dactinomycin (Cosmegen) by the following age-based criteria:
- Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- Age ≥ 3 years: 2.2 g/m2 IV infusion over 30 to 60 minutes once per day on day 1
- Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age ≥ 1 year: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age < 1 year: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Filgrastim (Neupogen) 5 μg/kg SubQ or IV (per institutional policy) once daily starting 24 hours after AC completion and continued once daily for 10 days or until ANC > 2000/μL
Chemotherapy, Week 10 and 11 Off Chemo
Chemotherapy, Week 12 Evaluation
References
- COG D9602: Raney RB, Walterhouse DO, Meza JL, Andrassy RJ, Breneman JC, Crist WM, Maurer HM, 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. Journal of Clinical Oncology. 2011 Apr 1;29(10):1312-1318. link to original article PubMed PMC Full Text NCT00002995
COG D9602 Subgroup B Clinical Group 2
Regimen
- Four 12-week cycles beginning on weeks 0, 12, 24, 36
Chemotherapy, Week 0
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- Age ≥ 3 years: 2.2 g/m2 IV infusion over 30 to 60 minutes once per day on day 1
- Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age ≥ 1 year: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age < 1 year: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Filgrastim (Neupogen) 5 μg/kg SubQ or IV (per institutional policy) once daily starting 24 hours after VAC completion and continued once daily for 10 days or until ANC > 2000/μL
Chemotherapy, Week 1
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 2
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 3
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- Age ≥ 3 years: 2.2 g/m2 IV infusion over 30 to 60 minutes once per day on day 1
- Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age ≥ 1 year: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age < 1 year: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Filgrastim (Neupogen) 5 μg/kg SubQ or IV (per institutional policy) once daily starting 24 hours after VAC completion and continued once daily for 10 days or until ANC > 2000/μL
- External beam radiotherapy 36 Gy given once daily in 20 divided fractions
Chemotherapy, Week 4
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 5
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 6
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- Age ≥ 3 years: 2.2 g/m2 IV infusion over 30 to 60 minutes once per day on day 1
- Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age ≥ 1 year: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age < 1 year: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Filgrastim (Neupogen) 5 μg/kg SubQ or IV (per institutional policy) once daily starting 24 hours after VAC completion and continued once daily for 10 days or until ANC > 2000/μL
Chemotherapy, Week 7
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 8
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Chemotherapy, Week 9
- Dactinomycin (Cosmegen) by the following age-based criteria:
- Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- Age ≥ 3 years: 2.2 g/m2 IV infusion over 30 to 60 minutes once per day on day 1
- Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age ≥ 1 year: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age < 1 year: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Filgrastim (Neupogen) 5 μg/kg SubQ or IV (per institutional policy) once daily starting 24 hours after AC completion and continued once daily for 10 days or until ANC > 2000/μL
Chemotherapy, Week 10 and 11 Off Chemo
Chemotherapy, Week 12 Evaluation
References
- COG D9602: Raney RB, Walterhouse DO, Meza JL, Andrassy RJ, Breneman JC, Crist WM, Maurer HM, 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. Journal of Clinical Oncology. 2011 Apr 1;29(10):1312-1318. link to original article PubMed PMC Full Text NCT00002995
COG D9602 Subgroup B Clinical Group 3
Chemotherapy
- Four 12-week cycles beginning on weeks 0, 12, 24, 36
Week 0
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- Age ≥ 3 years: 2.2 g/m2 IV infusion over 30 to 60 minutes once per day on day 1
- Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age ≥ 1 year: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age < 1 year: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Filgrastim (Neupogen) 5 μg/kg SubQ or IV (per institutional policy) once daily starting 24 hours after VAC completion and continued once daily for 10 days or until ANC > 2000/μL
Week 1
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Week 2
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Week 3
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- Age ≥ 3 years: 2.2 g/m2 IV infusion over 30 to 60 minutes once per day on day 1
- Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age ≥ 1 year: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age < 1 year: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Filgrastim (Neupogen) 5 μg/kg SubQ or IV (per institutional policy) once daily starting 24 hours after VAC completion and continued once daily for 10 days or until ANC > 2000/μL
- External beam radiotherapy 45 Gy given once daily in 25 divided fractions
Week 4
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Week 5
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Week 6
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- Age ≥ 3 years: 2.2 g/m2 IV infusion over 30 to 60 minutes once per day on day 1
- Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age ≥ 1 year: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age < 1 year: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Filgrastim (Neupogen) 5 μg/kg SubQ or IV (per institutional policy) once daily starting 24 hours after VAC completion and continued once daily for 10 days or until ANC > 2000/μL
Week 7
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Week 8
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Week 9
- Dactinomycin (Cosmegen) by the following age-based criteria:
- Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- Age ≥ 3 years: 2.2 g/m2 IV infusion over 30 to 60 minutes once per day on day 1
- Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 440 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age ≥ 1 year: 14.6 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Age < 1 year: 7.2 mg/m2 IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
- Filgrastim (Neupogen) 5 μg/kg SubQ or IV (per institutional policy) once daily starting 24 hours after AC completion and continued once daily for 10 days or until ANC > 2000/μL
Week 10 and 11 Off Chemo
Week 12 Evaluation
References
- COG D9602: Raney RB, Walterhouse DO, Meza JL, Andrassy RJ, Breneman JC, Crist WM, Maurer HM, 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. Journal of Clinical Oncology. 2011 Apr 1;29(10):1312-1318. link to original article PubMed PMC Full Text NCT00002995