Difference between revisions of "Rhabdomyosarcoma, pediatric"

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{{TOC limit|limit=4}}
−
 
 
=Intermediate Risk=
 
=Intermediate Risk=
−
 
 
==COG ARST1431 Protocol A (VAC/VI Only)==
 
==COG ARST1431 Protocol A (VAC/VI Only)==
 +
<div class="toccolours" style="background-color:#c8a2c8">
 +
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 +
!style="width: 20%"|Study
 +
!style="width: 20%"|Years of enrollment
 +
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 +
!style="width: 20%"|Comparator
 +
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 +
|-
 +
|[https://clinicaltrials.gov/ct2/show/NCT02567435 Awaiting publication (COG ARST1431)]
 +
|2016-2025
 +
| style="background-color:#1a9851" |Phase 3 (C)
 +
|[[#COG_ARST1431_Protocol_B_.28VAC.2FVI_.26_Temsirolimus.29|VAC/VI & Temsirolimus]]
 +
| style="background-color:#d3d3d3" |TBD
 +
|-
 +
|}
 +
<div class="toccolours" style="background-color:#eeeeee">
 
===Protocol, Cycles 1-4 (Weeks 1 through 12)===
 
===Protocol, Cycles 1-4 (Weeks 1 through 12)===
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
====Chemotherapy====
−
 
 
*[[Vincristine (Oncovin)]] by the following BSA-based criteria:
 
*[[Vincristine (Oncovin)]] by the following BSA-based criteria:
 
**0.25-0.29 m<sup>2</sup> BSA: 0.24 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 1 through 12
 
**0.25-0.29 m<sup>2</sup> BSA: 0.24 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 1 through 12
Line 27: Line 41:
 
**0.55-0.59 m<sup>2</sup> BSA: 0.8 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 1 through 12
 
**0.55-0.59 m<sup>2</sup> BSA: 0.8 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 1 through 12
 
**≥ 0.6 m<sup>2</sup> BSA: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 1 through 12
 
**≥ 0.6 m<sup>2</sup> BSA: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 1 through 12
−
 
 
*[[Dactinomycin (Cosmegen)]] by the following weight-based criteria:
 
*[[Dactinomycin (Cosmegen)]] by the following weight-based criteria:
 
**3-4.5 kg: 0.09 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 1 and 7
 
**3-4.5 kg: 0.09 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 1 and 7
Line 38: Line 51:
 
**12.6-13.9 kg: 0.6 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 1 and 7
 
**12.6-13.9 kg: 0.6 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 1 and 7
 
**≥14 kg: 0.05 mg/kg (maximum dose of 2.5 mg) slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 1 and 7
 
**≥14 kg: 0.05 mg/kg (maximum dose of 2.5 mg) slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 1 and 7
−
 
 
*[[Cyclophosphamide (Cytoxan)]] by the following BSA-based criteria:
 
*[[Cyclophosphamide (Cytoxan)]] by the following BSA-based criteria:
 
**0.25-0.29 m<sup>2</sup> BSA: 220 mg IV over 60 minutes on day 1 of weeks 1 and 7
 
**0.25-0.29 m<sup>2</sup> BSA: 220 mg IV over 60 minutes on day 1 of weeks 1 and 7
Line 48: Line 60:
 
**0.55-0.59 m<sup>2</sup> BSA: 660 mg IV over 60 minutes on day 1 of weeks 1 and 7
 
**0.55-0.59 m<sup>2</sup> BSA: 660 mg IV over 60 minutes on day 1 of weeks 1 and 7
 
**≥ 0.6 m<sup>2</sup> BSA: 1200 mg/m<sup>2</sup> IV over 60 minutes on day 1 of weeks 1 and 7
 
**≥ 0.6 m<sup>2</sup> BSA: 1200 mg/m<sup>2</sup> IV over 60 minutes on day 1 of weeks 1 and 7
−
 
−
 
−
 
 
*[[Irinotecan (Camptosar)]] by the following BSA-based criteria:
 
*[[Irinotecan (Camptosar)]] by the following BSA-based criteria:
 
**0.25-0.29 m<sup>2</sup> BSA: 8 mg IV over 90 minutes once daily on days 1 through 5 of weeks 4 and 10
 
**0.25-0.29 m<sup>2</sup> BSA: 8 mg IV over 90 minutes once daily on days 1 through 5 of weeks 4 and 10
Line 71: Line 80:
 
**≥ 0.6 m<sup>2</sup> BSA: 960 mg/m<sup>2</sup> IV over 15 to 30 minutes immediately before [[Cyclophosphamide (Cytoxan)]] infusion, and again 4 and 8 hours after the start of [[Cyclophosphamide (Cytoxan)]] infusion
 
**≥ 0.6 m<sup>2</sup> BSA: 960 mg/m<sup>2</sup> IV over 15 to 30 minutes immediately before [[Cyclophosphamide (Cytoxan)]] infusion, and again 4 and 8 hours after the start of [[Cyclophosphamide (Cytoxan)]] infusion
 
***[[Mesna (Mesnex)]] can also be given PO at twice the IV dose
 
***[[Mesna (Mesnex)]] can also be given PO at twice the IV dose
−
 
+
</div></div><br>
 +
<div class="toccolours" style="background-color:#eeeeee">
 
===Protocol, Cycles 5-10 (Weeks 13 through 30)===
 
===Protocol, Cycles 5-10 (Weeks 13 through 30)===
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
====Chemotherapy====
−
 
 
*[[Vincristine (Oncovin)]] by the following BSA-based criteria:
 
*[[Vincristine (Oncovin)]] by the following BSA-based criteria:
 
**0.25-0.29 m<sup>2</sup> BSA: 0.24 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 13, 16, 17, 19, 20, 22 through 26, 28
 
**0.25-0.29 m<sup>2</sup> BSA: 0.24 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 13, 16, 17, 19, 20, 22 through 26, 28
Line 84: Line 94:
 
**0.55-0.59 m<sup>2</sup> BSA: 0.8 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 13, 16, 17, 19, 20, 22 through 26, 28
 
**0.55-0.59 m<sup>2</sup> BSA: 0.8 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 13, 16, 17, 19, 20, 22 through 26, 28
 
**≥ 0.6 m<sup>2</sup> BSA: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 13, 16, 17, 19, 20, 22 through 26, 28
 
**≥ 0.6 m<sup>2</sup> BSA: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 13, 16, 17, 19, 20, 22 through 26, 28
−
 
 
*[[Dactinomycin (Cosmegen)]] by the following weight-based criteria:
 
*[[Dactinomycin (Cosmegen)]] by the following weight-based criteria:
 
**3-4.5 kg: 0.09 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 13, 22, 28
 
**3-4.5 kg: 0.09 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 13, 22, 28
Line 95: Line 104:
 
**12.6-13.9 kg: 0.6 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 13, 22, 28
 
**12.6-13.9 kg: 0.6 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 13, 22, 28
 
**≥14 kg: 0.05 mg/kg (maximum dose of 2.5 mg) slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 13, 22, 28
 
**≥14 kg: 0.05 mg/kg (maximum dose of 2.5 mg) slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 13, 22, 28
−
 
 
*[[Cyclophosphamide (Cytoxan)]] by the following BSA-based criteria:
 
*[[Cyclophosphamide (Cytoxan)]] by the following BSA-based criteria:
 
**0.25-0.29 m<sup>2</sup> BSA: 220 mg IV over 60 minutes on day 1 of weeks 13, 22, 28
 
**0.25-0.29 m<sup>2</sup> BSA: 220 mg IV over 60 minutes on day 1 of weeks 13, 22, 28
Line 125: Line 133:
 
**≥ 0.6 m<sup>2</sup> BSA: 960 mg/m<sup>2</sup> IV over 15 to 30 minutes immediately before [[Cyclophosphamide (Cytoxan)]] infusion, and again 4 and 8 hours after the start of [[Cyclophosphamide (Cytoxan)]] infusion
 
**≥ 0.6 m<sup>2</sup> BSA: 960 mg/m<sup>2</sup> IV over 15 to 30 minutes immediately before [[Cyclophosphamide (Cytoxan)]] infusion, and again 4 and 8 hours after the start of [[Cyclophosphamide (Cytoxan)]] infusion
 
***[[Mesna (Mesnex)]] can also be given PO at twice the IV dose
 
***[[Mesna (Mesnex)]] can also be given PO at twice the IV dose
−
 
+
</div></div><br>
−
 
+
<div class="toccolours" style="background-color:#eeeeee">
 
===Protocol, Cycles 11-14 (Weeks 31 through 42)===
 
===Protocol, Cycles 11-14 (Weeks 31 through 42)===
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
====Chemotherapy====
 
*[[Vincristine (Oncovin)]] by the following BSA-based criteria:
 
*[[Vincristine (Oncovin)]] by the following BSA-based criteria:
Line 138: Line 147:
 
**0.55-0.59 m<sup>2</sup> BSA: 0.8 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 31 through 34, 37, 38, 40
 
**0.55-0.59 m<sup>2</sup> BSA: 0.8 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 31 through 34, 37, 38, 40
 
**≥ 0.6 m<sup>2</sup> BSA: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 31 through 34, 37, 38, 40
 
**≥ 0.6 m<sup>2</sup> BSA: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 31 through 34, 37, 38, 40
−
 
 
*[[Dactinomycin (Cosmegen)]] by the following weight-based criteria:
 
*[[Dactinomycin (Cosmegen)]] by the following weight-based criteria:
 
**3-4.5 kg: 0.09 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 34, 40
 
**3-4.5 kg: 0.09 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 34, 40
Line 149: Line 157:
 
**12.6-13.9 kg: 0.6 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 34, 40
 
**12.6-13.9 kg: 0.6 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 34, 40
 
**≥14 kg: 0.05 mg/kg (maximum dose of 2.5 mg) slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 34, 40
 
**≥14 kg: 0.05 mg/kg (maximum dose of 2.5 mg) slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 34, 40
−
 
 
*[[Cyclophosphamide (Cytoxan)]] by the following BSA-based criteria:
 
*[[Cyclophosphamide (Cytoxan)]] by the following BSA-based criteria:
 
**0.25-0.29 m<sup>2</sup> BSA: 220 mg IV over 60 minutes on day 1 of weeks 34, 40
 
**0.25-0.29 m<sup>2</sup> BSA: 220 mg IV over 60 minutes on day 1 of weeks 34, 40
Line 179: Line 186:
 
**≥ 0.6 m<sup>2</sup> BSA: 960 mg/m<sup>2</sup> IV over 15 to 30 minutes immediately before [[Cyclophosphamide (Cytoxan)]] infusion, and again 4 and 8 hours after the start of [[Cyclophosphamide (Cytoxan)]] infusion
 
**≥ 0.6 m<sup>2</sup> BSA: 960 mg/m<sup>2</sup> IV over 15 to 30 minutes immediately before [[Cyclophosphamide (Cytoxan)]] infusion, and again 4 and 8 hours after the start of [[Cyclophosphamide (Cytoxan)]] infusion
 
***[[Mesna (Mesnex)]] can also be given PO at twice the IV dose
 
***[[Mesna (Mesnex)]] can also be given PO at twice the IV dose
−
 
+
</div></div><br>
−
 
+
<div class="toccolours" style="background-color:#eeeeee">
 
===Protocol, Maintenance Cycles 1-6===
 
===Protocol, Maintenance Cycles 1-6===
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
====Chemotherapy====
 
*[[Vinorelbine (Navelbine)]] by the following BSA-based criteria:
 
*[[Vinorelbine (Navelbine)]] by the following BSA-based criteria:
Line 192: Line 200:
 
**0.55-0.59 m<sup>2</sup> BSA: 14 mg IV push over 6 to 10 minutes on days 1, 8, and 15
 
**0.55-0.59 m<sup>2</sup> BSA: 14 mg IV push over 6 to 10 minutes on days 1, 8, and 15
 
**≥ 0.6 m<sup>2</sup> BSA: 25 mg/m<sup>2</sup> IV push over 6 to 10 minutes on days 1, 8, and 15
 
**≥ 0.6 m<sup>2</sup> BSA: 25 mg/m<sup>2</sup> IV push over 6 to 10 minutes on days 1, 8, and 15
−
 
 
*[[Cyclophosphamide (Cytoxan)]] 25 mg/m<sup>2</sup> PO once daily on days 1 through 28
 
*[[Cyclophosphamide (Cytoxan)]] 25 mg/m<sup>2</sup> PO once daily on days 1 through 28
 
**Dose rounded to the nearest 25 mg capsule
 
**Dose rounded to the nearest 25 mg capsule
−
 
 
'''28-day cycle'''
 
'''28-day cycle'''
−
 
+
</div></div></div>
 
===References===
 
===References===
−
# '''Vinorelbine and low dose cyclophosphamide maintenance therapy:''' Vinorelbine and low dose cyclophosphamide maintenance therapy: Bisogno G, De Salvo GL, Bergeron C, Gallego Melcons s, Merks JH, Kelsey A, Martelli H, Minard-Colin V, Orbach D, Glosli H, Chisholm J, Casanova M, Zanetti I, Devalck C, Ben-Arush M, Mudry P, Ferman S, Jenney M, Ferrari A. Vinorelbine and continuous low-dose cyclophosphamide as maintenance chemotherapy in patients with high-risk rhabdomyosarcoma (RMS 2005): a multicentre, open-label, randomised, phase 3 tial. Lancet Oncol. 2019 Nov;20(11):1566-1575. [https://doi.org/10.1016/S1470-2045(19)30617-5 link to original article] [https://pubmed.ncbi.nlm.nih.gov/31562043/ PubMed]
 
 
# '''COG ARST1431:''' [https://clinicaltrials.gov/ct2/show/NCT02567435 NCT02567435]
 
# '''COG ARST1431:''' [https://clinicaltrials.gov/ct2/show/NCT02567435 NCT02567435]
−
 
+
==COG ARST1431 Protocol B (VAC/VI & Temsirolimus)==
−
==COG ARST1431 Protocol B (VAC/VI Plus TORI)==
+
<div class="toccolours" style="background-color:#c8a2c8">
 +
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 +
!style="width: 20%"|Study
 +
!style="width: 20%"|Years of enrollment
 +
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 +
!style="width: 20%"|Comparator
 +
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 +
|-
 +
|[https://clinicaltrials.gov/ct2/show/NCT02567435 Awaiting publication (COG ARST1431)]
 +
|2016-2025
 +
| style="background-color:#1a9851" |Phase 3 (E-esc)
 +
|[[#COG_ARST1431_Protocol_B_.28VAC.2FVI.29|VAC/VI]]
 +
| style="background-color:#d3d3d3" |TBD if superior EFS (primary endpoint)
 +
|-
 +
|}
 +
<div class="toccolours" style="background-color:#eeeeee">
 
===Protocol, Cycles 1-4 (Weeks 1 through 12)===
 
===Protocol, Cycles 1-4 (Weeks 1 through 12)===
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
====Chemotherapy====
−
 
 
*[[Temsirolimus (Torisel)]] by the following weight-based criteria:
 
*[[Temsirolimus (Torisel)]] by the following weight-based criteria:
 
**< 10 kg: 0.5 mg/kg IV over 30 to 60 minutes once weekly on day 1 of weeks 1 through 12  
 
**< 10 kg: 0.5 mg/kg IV over 30 to 60 minutes once weekly on day 1 of weeks 1 through 12  
 
**> 10 kg: 15 mg/m<sup>2</sup> (maximum dose of 25 mg) IV on day 1 of weeks 1 through 12
 
**> 10 kg: 15 mg/m<sup>2</sup> (maximum dose of 25 mg) IV on day 1 of weeks 1 through 12
−
 
 
*[[Vincristine (Oncovin)]] by the following BSA-based criteria:
 
*[[Vincristine (Oncovin)]] by the following BSA-based criteria:
 
**0.25-0.29 m<sup>2</sup> BSA: 0.24 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 1 through 12
 
**0.25-0.29 m<sup>2</sup> BSA: 0.24 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 1 through 12
Line 219: Line 238:
 
**0.55-0.59 m<sup>2</sup> BSA: 0.8 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 1 through 12
 
**0.55-0.59 m<sup>2</sup> BSA: 0.8 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 1 through 12
 
**≥ 0.6 m<sup>2</sup> BSA: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 1 through 12
 
**≥ 0.6 m<sup>2</sup> BSA: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 1 through 12
−
 
 
*[[Dactinomycin (Cosmegen)]] by the following weight-based criteria:
 
*[[Dactinomycin (Cosmegen)]] by the following weight-based criteria:
 
**3-4.5 kg: 0.09 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 1 and 7
 
**3-4.5 kg: 0.09 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 1 and 7
Line 230: Line 248:
 
**12.6-13.9 kg: 0.6 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 1 and 7
 
**12.6-13.9 kg: 0.6 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 1 and 7
 
**≥14 kg: 0.05 mg/kg (maximum dose of 2.5 mg) slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 1 and 7
 
**≥14 kg: 0.05 mg/kg (maximum dose of 2.5 mg) slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 1 and 7
−
 
 
*[[Cyclophosphamide (Cytoxan)]] by the following BSA-based criteria:
 
*[[Cyclophosphamide (Cytoxan)]] by the following BSA-based criteria:
 
**0.25-0.29 m<sup>2</sup> BSA: 220 mg IV over 60 minutes on day 1 of weeks 1 and 7
 
**0.25-0.29 m<sup>2</sup> BSA: 220 mg IV over 60 minutes on day 1 of weeks 1 and 7
Line 260: Line 277:
 
**0.55-0.59 m<sup>2</sup> BSA: 528 mg IV over 15 to 30 minutes immediately before [[Cyclophosphamide (Cytoxan)]] infusion, and again 4 and 8 hours after the start of [[Cyclophosphamide (Cytoxan)]] infusion
 
**0.55-0.59 m<sup>2</sup> BSA: 528 mg IV over 15 to 30 minutes immediately before [[Cyclophosphamide (Cytoxan)]] infusion, and again 4 and 8 hours after the start of [[Cyclophosphamide (Cytoxan)]] infusion
 
**≥ 0.6 m<sup>2</sup> BSA: 960 mg/m<sup>2</sup> IV over 15 to 30 minutes immediately before [[Cyclophosphamide (Cytoxan)]] infusion, and again 4 and 8 hours after the start of [[Cyclophosphamide (Cytoxan)]] infusion
 
**≥ 0.6 m<sup>2</sup> BSA: 960 mg/m<sup>2</sup> IV over 15 to 30 minutes immediately before [[Cyclophosphamide (Cytoxan)]] infusion, and again 4 and 8 hours after the start of [[Cyclophosphamide (Cytoxan)]] infusion
−
 
+
</div></div><br>
−
 
+
<div class="toccolours" style="background-color:#eeeeee">
−
 
 
 
===Protocol, Cycles 5-10 (Weeks 13 through 30)===
 
===Protocol, Cycles 5-10 (Weeks 13 through 30)===
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
====Chemotherapy====
 
*[[Temsirolimus (Torisel)]] by the following weight-based criteria:
 
*[[Temsirolimus (Torisel)]] by the following weight-based criteria:
 
**< 10 kg: 0.5 mg/kg IV over 30 to 60 minutes once weekly on day 1 of weeks 21 through 30
 
**< 10 kg: 0.5 mg/kg IV over 30 to 60 minutes once weekly on day 1 of weeks 21 through 30
 
**> 10 kg: 15 mg/m<sup>2</sup> (maximum dose of 25 mg) IV on day 1 of weeks 21 through 30
 
**> 10 kg: 15 mg/m<sup>2</sup> (maximum dose of 25 mg) IV on day 1 of weeks 21 through 30
−
 
 
*[[Vincristine (Oncovin)]] by the following BSA-based criteria:
 
*[[Vincristine (Oncovin)]] by the following BSA-based criteria:
 
**0.25-0.29 m<sup>2</sup> BSA: 0.24 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 13, 16, 17, 19, 20, 22 through 26, 28
 
**0.25-0.29 m<sup>2</sup> BSA: 0.24 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 13, 16, 17, 19, 20, 22 through 26, 28
Line 278: Line 294:
 
**0.55-0.59 m<sup>2</sup> BSA: 0.8 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 13, 16, 17, 19, 20, 22 through 26, 28
 
**0.55-0.59 m<sup>2</sup> BSA: 0.8 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 13, 16, 17, 19, 20, 22 through 26, 28
 
**≥ 0.6 m<sup>2</sup> BSA: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 13, 16, 17, 19, 20, 22 through 26, 28
 
**≥ 0.6 m<sup>2</sup> BSA: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 13, 16, 17, 19, 20, 22 through 26, 28
−
 
 
*[[Dactinomycin (Cosmegen)]] by the following weight-based criteria:
 
*[[Dactinomycin (Cosmegen)]] by the following weight-based criteria:
 
**3-4.5 kg: 0.09 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 13, 22, 28
 
**3-4.5 kg: 0.09 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 13, 22, 28
Line 290: Line 305:
 
**≥14 kg: 0.05 mg/kg (maximum dose of 2.5 mg) slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 13, 22, 28
 
**≥14 kg: 0.05 mg/kg (maximum dose of 2.5 mg) slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 13, 22, 28
 
  Give week 13 dose of [[Dactinomycin (Cosmegen)]] before beginning radiation therapy
 
  Give week 13 dose of [[Dactinomycin (Cosmegen)]] before beginning radiation therapy
−
 
 
*[[Cyclophosphamide (Cytoxan)]] by the following BSA-based criteria:
 
*[[Cyclophosphamide (Cytoxan)]] by the following BSA-based criteria:
 
**0.25-0.29 m<sup>2</sup> BSA: 220 mg IV over 60 minutes on day 1 of weeks 13, 22, 28
 
**0.25-0.29 m<sup>2</sup> BSA: 220 mg IV over 60 minutes on day 1 of weeks 13, 22, 28
Line 320: Line 334:
 
**0.55-0.59 m<sup>2</sup> BSA: 528 mg IV over 15 to 30 minutes immediately before [[Cyclophosphamide (Cytoxan)]] infusion, and again 4 and 8 hours after the start of [[Cyclophosphamide (Cytoxan)]] infusion
 
**0.55-0.59 m<sup>2</sup> BSA: 528 mg IV over 15 to 30 minutes immediately before [[Cyclophosphamide (Cytoxan)]] infusion, and again 4 and 8 hours after the start of [[Cyclophosphamide (Cytoxan)]] infusion
 
**≥ 0.6 m<sup>2</sup> BSA: 960 mg/m<sup>2</sup> IV over 15 to 30 minutes immediately before [[Cyclophosphamide (Cytoxan)]] infusion, and again 4 and 8 hours after the start of [[Cyclophosphamide (Cytoxan)]] infusion
 
**≥ 0.6 m<sup>2</sup> BSA: 960 mg/m<sup>2</sup> IV over 15 to 30 minutes immediately before [[Cyclophosphamide (Cytoxan)]] infusion, and again 4 and 8 hours after the start of [[Cyclophosphamide (Cytoxan)]] infusion
−
 
+
</div></div><br>
−
 
+
<div class="toccolours" style="background-color:#eeeeee">
−
 
 
 
===Protocol, Cycles 11-14 (Weeks 31 through 42)===
 
===Protocol, Cycles 11-14 (Weeks 31 through 42)===
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
====Chemotherapy====
 
*[[Temsirolimus (Torisel)]] by the following weight-based criteria:
 
*[[Temsirolimus (Torisel)]] by the following weight-based criteria:
 
**< 10 kg: 0.5 mg/kg IV over 30 to 60 minutes once weekly on day 1 of weeks 31 through 42
 
**< 10 kg: 0.5 mg/kg IV over 30 to 60 minutes once weekly on day 1 of weeks 31 through 42
 
**> 10 kg: 15 mg/m<sup>2</sup> (maximum dose of 25 mg) IV on day 1 of weeks 31 through 42
 
**> 10 kg: 15 mg/m<sup>2</sup> (maximum dose of 25 mg) IV on day 1 of weeks 31 through 42
−
 
 
*[[Vincristine (Oncovin)]] by the following BSA-based criteria:
 
*[[Vincristine (Oncovin)]] by the following BSA-based criteria:
 
**0.25-0.29 m<sup>2</sup> BSA: 0.24 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 31 through 34, 37, 38, 40
 
**0.25-0.29 m<sup>2</sup> BSA: 0.24 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 31 through 34, 37, 38, 40
Line 338: Line 351:
 
**0.55-0.59 m<sup>2</sup> BSA: 0.8 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 31 through 34, 37, 38, 40
 
**0.55-0.59 m<sup>2</sup> BSA: 0.8 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 31 through 34, 37, 38, 40
 
**≥ 0.6 m<sup>2</sup> BSA: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 31 through 34, 37, 38, 40
 
**≥ 0.6 m<sup>2</sup> BSA: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 31 through 34, 37, 38, 40
−
 
 
*[[Dactinomycin (Cosmegen)]] by the following weight-based criteria:
 
*[[Dactinomycin (Cosmegen)]] by the following weight-based criteria:
 
**3-4.5 kg: 0.09 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 34, 40
 
**3-4.5 kg: 0.09 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 34, 40
Line 349: Line 361:
 
**12.6-13.9 kg: 0.6 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 34, 40
 
**12.6-13.9 kg: 0.6 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 34, 40
 
**≥14 kg: 0.05 mg/kg (maximum dose of 2.5 mg) slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 34, 40
 
**≥14 kg: 0.05 mg/kg (maximum dose of 2.5 mg) slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 34, 40
−
 
 
*[[Cyclophosphamide (Cytoxan)]] by the following BSA-based criteria:
 
*[[Cyclophosphamide (Cytoxan)]] by the following BSA-based criteria:
 
**0.25-0.29 m<sup>2</sup> BSA: 220 mg IV over 60 minutes on day 1 of weeks 34, 40
 
**0.25-0.29 m<sup>2</sup> BSA: 220 mg IV over 60 minutes on day 1 of weeks 34, 40
Line 379: Line 390:
 
**0.55-0.59 m<sup>2</sup> BSA: 528 mg IV over 15 to 30 minutes immediately before [[Cyclophosphamide (Cytoxan)]] infusion, and again 4 and 8 hours after the start of [[Cyclophosphamide (Cytoxan)]] infusion
 
**0.55-0.59 m<sup>2</sup> BSA: 528 mg IV over 15 to 30 minutes immediately before [[Cyclophosphamide (Cytoxan)]] infusion, and again 4 and 8 hours after the start of [[Cyclophosphamide (Cytoxan)]] infusion
 
**≥ 0.6 m<sup>2</sup> BSA: 960 mg/m<sup>2</sup> IV over 15 to 30 minutes immediately before [[Cyclophosphamide (Cytoxan)]] infusion, and again 4 and 8 hours after the start of [[Cyclophosphamide (Cytoxan)]] infusion
 
**≥ 0.6 m<sup>2</sup> BSA: 960 mg/m<sup>2</sup> IV over 15 to 30 minutes immediately before [[Cyclophosphamide (Cytoxan)]] infusion, and again 4 and 8 hours after the start of [[Cyclophosphamide (Cytoxan)]] infusion
−
 
+
</div></div><br>
−
 
+
<div class="toccolours" style="background-color:#eeeeee">
−
 
 
 
===Protocol, Maintenance Cycles 1-6===
 
===Protocol, Maintenance Cycles 1-6===
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
====Chemotherapy====
 
*[[Vinorelbine (Navelbine)]] by the following BSA-based criteria:
 
*[[Vinorelbine (Navelbine)]] by the following BSA-based criteria:
Line 393: Line 404:
 
**0.55-0.59 m<sup>2</sup> BSA: 14 mg IV push over 6 to 10 minutes on days 1, 8, and 15
 
**0.55-0.59 m<sup>2</sup> BSA: 14 mg IV push over 6 to 10 minutes on days 1, 8, and 15
 
**≥ 0.6 m<sup>2</sup> BSA: 25 mg/m<sup>2</sup> IV push over 6 to 10 minutes on days 1, 8, and 15
 
**≥ 0.6 m<sup>2</sup> BSA: 25 mg/m<sup>2</sup> IV push over 6 to 10 minutes on days 1, 8, and 15
−
 
 
*[[Cyclophosphamide (Cytoxan)]] 25 mg/m<sup>2</sup> PO once daily on days 1 through 28
 
*[[Cyclophosphamide (Cytoxan)]] 25 mg/m<sup>2</sup> PO once daily on days 1 through 28
 
**Dose rounded to the nearest 25 mg capsule
 
**Dose rounded to the nearest 25 mg capsule
−
 
 
'''28-day cycle'''
 
'''28-day cycle'''
−
 
+
</div></div></div>
 
===References===
 
===References===
−
# '''Vinorelbine and low dose cyclophosphamide maintenance therapy:''' Vinorelbine and low dose cyclophosphamide maintenance therapy: Bisogno G, De Salvo GL, Bergeron C, Gallego Melcons s, Merks JH, Kelsey A, Martelli H, Minard-Colin V, Orbach D, Glosli H, Chisholm J, Casanova M, Zanetti I, Devalck C, Ben-Arush M, Mudry P, Ferman S, Jenney M, Ferrari A. Vinorelbine and continuous low-dose cyclophosphamide as maintenance chemotherapy in patients with high-risk rhabdomyosarcoma (RMS 2005): a multicentre, open-label, randomised, phase 3 tial. Lancet Oncol. 2019 Nov;20(11):1566-1575. [https://doi.org/10.1016/S1470-2045(19)30617-5 link to original article] [https://pubmed.ncbi.nlm.nih.gov/31562043/ PubMed]
 
 
# '''COG ARST1431:''' [https://clinicaltrials.gov/ct2/show/NCT02567435 NCT02567435]
 
# '''COG ARST1431:''' [https://clinicaltrials.gov/ct2/show/NCT02567435 NCT02567435]
−
 
 
==COG ARST0531 VAC Arm==
 
==COG ARST0531 VAC Arm==
 +
<div class="toccolours" style="background-color:#c8a2c8">
 +
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 +
!style="width: 20%"|Study
 +
!style="width: 20%"|Years of enrollment
 +
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 +
!style="width: 20%"|Comparator
 +
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 +
|-
 +
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6145831/ Hawkins et al. 2018 (COG ARST0531)]
 +
|2006-2012
 +
| style="background-color:#1a9851" |Phase 3 (C)
 +
|[[#COG_ARST0531_VAC.2FVI_Arm|VAC/VI]]
 +
| style="background-color:#ffffbf" |Did not meet primary endpoint of EFS
 +
|-
 +
|}
 +
<div class="toccolours" style="background-color:#eeeeee">
 
===Protocol, Weeks 1-15===
 
===Protocol, Weeks 1-15===
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
Line 419: Line 442:
 
|-
 
|-
 
|}
 
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy, Week 1====
 
====Chemotherapy, Week 1====
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
Line 460: Line 484:
 
**Age ≥ 3 years: 240 mg/m<sup>2</sup> at hour 0, 4, and 8 from the start of each [[Cyclophosphamide (Cytoxan)]] infusion on days 1
 
**Age ≥ 3 years: 240 mg/m<sup>2</sup> at hour 0, 4, and 8 from the start of each [[Cyclophosphamide (Cytoxan)]] infusion on days 1
 
**Age < 3 years: 8 mg/kg at hour 0, 4, and 8 from the start of each [[Cyclophosphamide (Cytoxan)]] infusion on days 1
 
**Age < 3 years: 8 mg/kg at hour 0, 4, and 8 from the start of each [[Cyclophosphamide (Cytoxan)]] infusion on days 1
−
 
 
====Chemotherapy, Week 5====
 
====Chemotherapy, Week 5====
 
*Radiation therapy continues
 
*Radiation therapy continues
Line 467: Line 490:
 
**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
−
 
 
====Chemotherapy, Week 6====
 
====Chemotherapy, Week 6====
 
*Radiation therapy continues
 
*Radiation therapy continues
Line 474: Line 496:
 
**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
−
 
 
====Chemotherapy, Week 7====
 
====Chemotherapy, Week 7====
 
*Radiation therapy continues
 
*Radiation therapy continues
Line 488: Line 509:
 
**Age ≥ 3 years: 240 mg/m<sup>2</sup> at hour 0, 4, and 8 from the start of each [[Cyclophosphamide (Cytoxan)]] infusion on days 1
 
**Age ≥ 3 years: 240 mg/m<sup>2</sup> at hour 0, 4, and 8 from the start of each [[Cyclophosphamide (Cytoxan)]] infusion on days 1
 
**Age < 3 years: 8 mg/kg at hour 0, 4, and 8 from the start of each [[Cyclophosphamide (Cytoxan)]] infusion on days 1
 
**Age < 3 years: 8 mg/kg at hour 0, 4, and 8 from the start of each [[Cyclophosphamide (Cytoxan)]] infusion on days 1
−
 
 
====Chemotherapy, Week 8====
 
====Chemotherapy, Week 8====
 
*Radiation therapy continues
 
*Radiation therapy continues
Line 495: Line 515:
 
**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
−
 
 
====Chemotherapy, Week 9====
 
====Chemotherapy, Week 9====
 
*Radiation therapy final week
 
*Radiation therapy final week
Line 502: Line 521:
 
**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
−
 
 
====Chemotherapy, Week 10====
 
====Chemotherapy, Week 10====
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
Line 541: Line 559:
 
**Age < 3 years: 8 mg/kg at hour 0, 4, and 8 from the start of each [[Cyclophosphamide (Cytoxan)]] infusion on days 1
 
**Age < 3 years: 8 mg/kg at hour 0, 4, and 8 from the start of each [[Cyclophosphamide (Cytoxan)]] infusion on days 1
 
====Chemotherapy, Week 14 Off Chemo====
 
====Chemotherapy, Week 14 Off Chemo====
−
 
 
====Chemotherapy, Week 15 Evaluation====
 
====Chemotherapy, Week 15 Evaluation====
−
 
+
</div></div><br>
 +
<div class="toccolours" style="background-color:#eeeeee">
 
===Protocol, Weeks 16-30===
 
===Protocol, Weeks 16-30===
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy, Week 16====
 
====Chemotherapy, Week 16====
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
Line 561: Line 580:
 
**Age < 3 years: 8 mg/kg at hour 0, 4, and 8 from the start of each [[Cyclophosphamide (Cytoxan)]] infusion on days 1
 
**Age < 3 years: 8 mg/kg at hour 0, 4, and 8 from the start of each [[Cyclophosphamide (Cytoxan)]] infusion on days 1
 
====Chemotherapy, Week 17 Off Chemo====
 
====Chemotherapy, Week 17 Off Chemo====
−
 
 
====Chemotherapy, Week 18 Off Chemo====
 
====Chemotherapy, Week 18 Off Chemo====
−
 
 
====Chemotherapy, Week 19====
 
====Chemotherapy, Week 19====
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
Line 630: Line 647:
 
**Age < 3 years: 8 mg/kg at hour 0, 4, and 8 from the start of each [[Cyclophosphamide (Cytoxan)]] infusion on days 1
 
**Age < 3 years: 8 mg/kg at hour 0, 4, and 8 from the start of each [[Cyclophosphamide (Cytoxan)]] infusion on days 1
 
====Chemotherapy, Week 26 Off Chemo====
 
====Chemotherapy, Week 26 Off Chemo====
−
 
 
====Chemotherapy, Week 27 Off Chemo====
 
====Chemotherapy, Week 27 Off Chemo====
−
 
 
====Chemotherapy, Week 28====
 
====Chemotherapy, Week 28====
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
Line 649: Line 664:
 
**Age < 3 years: 8 mg/kg at hour 0, 4, and 8 from the start of each [[Cyclophosphamide (Cytoxan)]] infusion on days 1
 
**Age < 3 years: 8 mg/kg at hour 0, 4, and 8 from the start of each [[Cyclophosphamide (Cytoxan)]] infusion on days 1
 
====Chemotherapy, Week 29 Off Chemo====
 
====Chemotherapy, Week 29 Off Chemo====
−
 
 
====Chemotherapy, Week 30 Evaluation====
 
====Chemotherapy, Week 30 Evaluation====
−
 
+
</div></div><br>
 +
<div class="toccolours" style="background-color:#eeeeee">
 
===Protocol, Weeks 31-43===
 
===Protocol, Weeks 31-43===
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy, Week 31====
 
====Chemotherapy, Week 31====
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
Line 719: Line 735:
 
**Age < 3 years: 8 mg/kg at hour 0, 4, and 8 from the start of each [[Cyclophosphamide (Cytoxan)]] infusion on days 1
 
**Age < 3 years: 8 mg/kg at hour 0, 4, and 8 from the start of each [[Cyclophosphamide (Cytoxan)]] infusion on days 1
 
====Chemotherapy, Week 38 Off Chemo====
 
====Chemotherapy, Week 38 Off Chemo====
−
 
 
====Chemotherapy, Week 39 Off Chemo====
 
====Chemotherapy, Week 39 Off Chemo====
−
 
 
====Chemotherapy, Week 40====
 
====Chemotherapy, Week 40====
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
Line 738: Line 752:
 
**Age < 3 years: 8 mg/kg at hour 0, 4, and 8 from the start of each [[Cyclophosphamide (Cytoxan)]] infusion on days 1
 
**Age < 3 years: 8 mg/kg at hour 0, 4, and 8 from the start of each [[Cyclophosphamide (Cytoxan)]] infusion on days 1
 
====Chemotherapy, Week 41 Off Chemo====
 
====Chemotherapy, Week 41 Off Chemo====
−
 
 
====Chemotherapy, Week 42 Off Chemo====
 
====Chemotherapy, Week 42 Off Chemo====
−
 
 
====Chemotherapy, Week 43 Evaluation====
 
====Chemotherapy, Week 43 Evaluation====
 +
</div></div></div>
 
===References===
 
===References===
 
# '''COG ARST0531:''' Hawkins DS, Chi Y, Anderson JR, Tian J, Arndt CAS, Bomgaars L, Donaldson SS, Hayes-Jordan A, Mascarenhas L, McCarville MB, McCune JS, McCowage G, Million L, Morris CD, Parham DM, Rodeberg DA, Rudzinski ER, Shnorhavorian M, Spunt SL, Skapek SX, Teot LA, Wolden S, Yock TI, Meyer WH. Addition of Vincristine and Irinotecan to Vincristine, Dactinomycin, and Cyclophosphamide Does Not Improve Outcome for Intermediate-Risk Rhabdomyosarcoma: A Report From the Children's Oncology Group. J Clin Oncol. 2018 Sep;36(27):2770-2777. Epub 2018 Aug 9. [https://doi.org/10.1200/JCO.2018.77.9694 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6145831/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/30091945/ PubMed] NCT01222715
 
# '''COG ARST0531:''' Hawkins DS, Chi Y, Anderson JR, Tian J, Arndt CAS, Bomgaars L, Donaldson SS, Hayes-Jordan A, Mascarenhas L, McCarville MB, McCune JS, McCowage G, Million L, Morris CD, Parham DM, Rodeberg DA, Rudzinski ER, Shnorhavorian M, Spunt SL, Skapek SX, Teot LA, Wolden S, Yock TI, Meyer WH. Addition of Vincristine and Irinotecan to Vincristine, Dactinomycin, and Cyclophosphamide Does Not Improve Outcome for Intermediate-Risk Rhabdomyosarcoma: A Report From the Children's Oncology Group. J Clin Oncol. 2018 Sep;36(27):2770-2777. Epub 2018 Aug 9. [https://doi.org/10.1200/JCO.2018.77.9694 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6145831/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/30091945/ PubMed] NCT01222715
−
 
 
==COG ARST0531 VAC/VI Arm==
 
==COG ARST0531 VAC/VI Arm==
−
===Protocol, Weeks 1-15===
+
<div class="toccolours" style="background-color:#c8a2c8">
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
!style="width: 20%"|Study
 
!style="width: 20%"|Study
Line 758: Line 770:
 
| style="background-color:#1a9851" |Phase 3 (E-switch-ic)
 
| style="background-color:#1a9851" |Phase 3 (E-switch-ic)
 
|[[#COG_ARST0531_VAC_Arm|VAC]]
 
|[[#COG_ARST0531_VAC_Arm|VAC]]
−
| style="background-color:#ffffbf" |Did not meet primary endpoint of EFS
+
| style="background-color:#ffffbf" |Did not meet primary endpoint of EFS<br>EFS48: 59% vs 63%
 
|-
 
|-
 
|}
 
|}
 +
<div class="toccolours" style="background-color:#eeeeee">
 +
===Protocol, Weeks 1-15===
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy, Week 1====
 
====Chemotherapy, Week 1====
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
Line 794: Line 809:
 
***Administer [[Vincristine (Oncovin)]] before [[Irinotecan (Camptosar)]]
 
***Administer [[Vincristine (Oncovin)]] before [[Irinotecan (Camptosar)]]
 
*[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 100 mg/day) IV over 90 minutes once per day on days 1 through 5
 
*[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 100 mg/day) IV over 90 minutes once per day on days 1 through 5
−
 
 
====Chemotherapy, Week 5====
 
====Chemotherapy, Week 5====
 
*Radiation therapy continues
 
*Radiation therapy continues
Line 815: Line 829:
 
***Administer [[Vincristine (Oncovin)]] before [[Irinotecan (Camptosar)]]
 
***Administer [[Vincristine (Oncovin)]] before [[Irinotecan (Camptosar)]]
 
*[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 100 mg/day) IV over 90 minutes once per day on days 1 through 5
 
*[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 100 mg/day) IV over 90 minutes once per day on days 1 through 5
−
 
 
====Chemotherapy, Week 8====
 
====Chemotherapy, Week 8====
 
*Radiation therapy continues
 
*Radiation therapy continues
Line 866: Line 879:
 
**Age < 3 years: 8 mg/kg at hour 0, 4, and 8 from the start of each [[Cyclophosphamide (Cytoxan)]] infusion on days 1
 
**Age < 3 years: 8 mg/kg at hour 0, 4, and 8 from the start of each [[Cyclophosphamide (Cytoxan)]] infusion on days 1
 
====Chemotherapy, Week 14 Off Chemo====
 
====Chemotherapy, Week 14 Off Chemo====
−
 
 
====Chemotherapy, Week 15 Evaluation====
 
====Chemotherapy, Week 15 Evaluation====
−
 
+
</div></div><br>
−
 
+
<div class="toccolours" style="background-color:#eeeeee">
 
===Protocol, Weeks 16-30===
 
===Protocol, Weeks 16-30===
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy, Week 16====
 
====Chemotherapy, Week 16====
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
Line 878: Line 891:
 
***Administer [[Vincristine (Oncovin)]] before [[Irinotecan (Camptosar)]]
 
***Administer [[Vincristine (Oncovin)]] before [[Irinotecan (Camptosar)]]
 
*[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 100 mg/day) IV over 90 minutes once per day on days 1 through 5
 
*[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 100 mg/day) IV over 90 minutes once per day on days 1 through 5
−
 
 
====Chemotherapy, Week 17====
 
====Chemotherapy, Week 17====
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
Line 885: Line 897:
 
**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
 
====Chemotherapy, Week 18 Off Chemo====
 
====Chemotherapy, Week 18 Off Chemo====
−
 
 
====Chemotherapy, Week 19====
 
====Chemotherapy, Week 19====
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
Line 893: Line 904:
 
***Administer [[Vincristine (Oncovin)]] before [[Irinotecan (Camptosar)]]
 
***Administer [[Vincristine (Oncovin)]] before [[Irinotecan (Camptosar)]]
 
*[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 100 mg/day) IV over 90 minutes once per day on days 1 through 5
 
*[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 100 mg/day) IV over 90 minutes once per day on days 1 through 5
−
 
 
====Chemotherapy, Week 20====
 
====Chemotherapy, Week 20====
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
Line 900: Line 910:
 
**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
 
====Chemotherapy, Week 21 Off Chemo====
 
====Chemotherapy, Week 21 Off Chemo====
−
 
 
====Chemotherapy, Week 22====
 
====Chemotherapy, Week 22====
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
Line 933: Line 942:
 
***Administer [[Vincristine (Oncovin)]] before [[Irinotecan (Camptosar)]]
 
***Administer [[Vincristine (Oncovin)]] before [[Irinotecan (Camptosar)]]
 
*[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 100 mg/day) IV over 90 minutes once per day on days 1 through 5
 
*[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 100 mg/day) IV over 90 minutes once per day on days 1 through 5
−
 
 
====Chemotherapy, Week 26====
 
====Chemotherapy, Week 26====
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
Line 940: Line 948:
 
**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
 
====Chemotherapy, Week 27 Off Chemo====
 
====Chemotherapy, Week 27 Off Chemo====
−
 
 
====Chemotherapy, Week 28====
 
====Chemotherapy, Week 28====
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
Line 957: Line 964:
 
**Age < 3 years: 8 mg/kg at hour 0, 4, and 8 from the start of each [[Cyclophosphamide (Cytoxan)]] infusion on days 1
 
**Age < 3 years: 8 mg/kg at hour 0, 4, and 8 from the start of each [[Cyclophosphamide (Cytoxan)]] infusion on days 1
 
====Chemotherapy, Week 29 Off Chemo====
 
====Chemotherapy, Week 29 Off Chemo====
−
 
 
====Chemotherapy, Week 30 Evaluation====
 
====Chemotherapy, Week 30 Evaluation====
−
 
+
</div></div><br>
 +
<div class="toccolours" style="background-color:#eeeeee">
 
===Protocol, Weeks 31-43===
 
===Protocol, Weeks 31-43===
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy, Week 31====
 
====Chemotherapy, Week 31====
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
Line 968: Line 976:
 
***Administer [[Vincristine (Oncovin)]] before [[Irinotecan (Camptosar)]]
 
***Administer [[Vincristine (Oncovin)]] before [[Irinotecan (Camptosar)]]
 
*[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 100 mg/day) IV over 90 minutes once per day on days 1 through 5
 
*[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 100 mg/day) IV over 90 minutes once per day on days 1 through 5
−
 
 
====Chemotherapy, Week 32====
 
====Chemotherapy, Week 32====
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
Line 995: Line 1,002:
 
**Age < 3 years: 8 mg/kg at hour 0, 4, and 8 from the start of each [[Cyclophosphamide (Cytoxan)]] infusion on days 1
 
**Age < 3 years: 8 mg/kg at hour 0, 4, and 8 from the start of each [[Cyclophosphamide (Cytoxan)]] infusion on days 1
 
====Chemotherapy, Week 35 Off Chemo====
 
====Chemotherapy, Week 35 Off Chemo====
−
 
 
====Chemotherapy, Week 36 Off Chemo====
 
====Chemotherapy, Week 36 Off Chemo====
−
 
 
====Chemotherapy, Week 37====
 
====Chemotherapy, Week 37====
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
Line 1,005: Line 1,010:
 
***Administer [[Vincristine (Oncovin)]] before [[Irinotecan (Camptosar)]]
 
***Administer [[Vincristine (Oncovin)]] before [[Irinotecan (Camptosar)]]
 
*[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 100 mg/day) IV over 90 minutes once per day on days 1 through 5
 
*[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 100 mg/day) IV over 90 minutes once per day on days 1 through 5
−
 
 
====Chemotherapy, Week 38====
 
====Chemotherapy, Week 38====
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
Line 1,012: Line 1,016:
 
**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
 
====Chemotherapy, Week 39 Off Chemo====
 
====Chemotherapy, Week 39 Off Chemo====
−
 
 
====Chemotherapy, Week 40====
 
====Chemotherapy, Week 40====
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
Line 1,028: Line 1,031:
 
**Age < 3 years: 8 mg/kg at hour 0, 4, and 8 from the start of each [[Cyclophosphamide (Cytoxan)]] infusion on days 1
 
**Age < 3 years: 8 mg/kg at hour 0, 4, and 8 from the start of each [[Cyclophosphamide (Cytoxan)]] infusion on days 1
 
====Chemotherapy, Week 41 Off Chemo====
 
====Chemotherapy, Week 41 Off Chemo====
−
 
 
====Chemotherapy, Week 42 Off Chemo====
 
====Chemotherapy, Week 42 Off Chemo====
−
 
 
====Chemotherapy, Week 43 Evaluation====
 
====Chemotherapy, Week 43 Evaluation====
−
 
+
</div></div></div>
−
 
 
−
 
 
 
===References===
 
===References===
 
# '''COG ARST0531:''' Hawkins DS, Chi Y, Anderson JR, Tian J, Arndt CAS, Bomgaars L, Donaldson SS, Hayes-Jordan A, Mascarenhas L, McCarville MB, McCune JS, McCowage G, Million L, Morris CD, Parham DM, Rodeberg DA, Rudzinski ER, Shnorhavorian M, Spunt SL, Skapek SX, Teot LA, Wolden S, Yock TI, Meyer WH. Addition of Vincristine and Irinotecan to Vincristine, Dactinomycin, and Cyclophosphamide Does Not Improve Outcome for Intermediate-Risk Rhabdomyosarcoma: A Report From the Children's Oncology Group. J Clin Oncol. 2018 Sep;36(27):2770-2777. Epub 2018 Aug 9. [https://doi.org/10.1200/JCO.2018.77.9694 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6145831/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/30091945/ PubMed] NCT01222715
 
# '''COG ARST0531:''' Hawkins DS, Chi Y, Anderson JR, Tian J, Arndt CAS, Bomgaars L, Donaldson SS, Hayes-Jordan A, Mascarenhas L, McCarville MB, McCune JS, McCowage G, Million L, Morris CD, Parham DM, Rodeberg DA, Rudzinski ER, Shnorhavorian M, Spunt SL, Skapek SX, Teot LA, Wolden S, Yock TI, Meyer WH. Addition of Vincristine and Irinotecan to Vincristine, Dactinomycin, and Cyclophosphamide Does Not Improve Outcome for Intermediate-Risk Rhabdomyosarcoma: A Report From the Children's Oncology Group. J Clin Oncol. 2018 Sep;36(27):2770-2777. Epub 2018 Aug 9. [https://doi.org/10.1200/JCO.2018.77.9694 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6145831/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/30091945/ PubMed] NCT01222715
−
 
 
=Low Risk=
 
=Low Risk=
−
==COG ARST1431 Protocol C (VAC/VA Only)==
+
==COG ARST1431 Protocol C (VAC/VA)==
 +
<div class="toccolours" style="background-color:#c8a2c8">
 +
{| class="wikitable sortable" style="width: 60%; text-align:center;"
 +
!style="width: 33%"|Study
 +
!style="width: 33%"|Years of enrollment
 +
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 +
|-
 +
|[https://clinicaltrials.gov/ct2/show/NCT02567435 Awaiting publication (COG ARST1431)]
 +
|2016-2025
 +
| style="background-color:#91cf61" |Non-randomized arm of phase 3 RCT
 +
|-
 +
|}
 +
<div class="toccolours" style="background-color:#eeeeee">
 
===Protocol, Cycles 1-4 (Weeks 1 through 12)===
 
===Protocol, Cycles 1-4 (Weeks 1 through 12)===
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
====Chemotherapy====
−
 
 
*[[Vincristine (Oncovin)]] by the following BSA-based criteria:
 
*[[Vincristine (Oncovin)]] by the following BSA-based criteria:
 
**0.25-0.29 m<sup>2</sup> BSA: 0.24 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 1 through 10
 
**0.25-0.29 m<sup>2</sup> BSA: 0.24 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 1 through 10
Line 1,052: Line 1,062:
 
**0.55-0.59 m<sup>2</sup> BSA: 0.8 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 1 through 10
 
**0.55-0.59 m<sup>2</sup> BSA: 0.8 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 1 through 10
 
**≥ 0.6 m<sup>2</sup> BSA: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 1 through 10
 
**≥ 0.6 m<sup>2</sup> BSA: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 1 through 10
−
 
 
*[[Dactinomycin (Cosmegen)]] by the following weight-based criteria:
 
*[[Dactinomycin (Cosmegen)]] by the following weight-based criteria:
 
**3-4.5 kg: 0.09 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 1, 4, 7, 10
 
**3-4.5 kg: 0.09 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 1, 4, 7, 10
Line 1,063: Line 1,072:
 
**12.6-13.9 kg: 0.6 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 1, 4, 7, 10
 
**12.6-13.9 kg: 0.6 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 1, 4, 7, 10
 
**≥14 kg: 0.05 mg/kg (maximum dose of 2.5 mg) slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 1, 4, 7, 10
 
**≥14 kg: 0.05 mg/kg (maximum dose of 2.5 mg) slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 1, 4, 7, 10
−
 
 
*[[Cyclophosphamide (Cytoxan)]] by the following BSA-based criteria:
 
*[[Cyclophosphamide (Cytoxan)]] by the following BSA-based criteria:
 
**0.25-0.29 m<sup>2</sup> BSA: 220 mg IV over 60 minutes on day 1 of weeks 1, 4, 7, 10
 
**0.25-0.29 m<sup>2</sup> BSA: 220 mg IV over 60 minutes on day 1 of weeks 1, 4, 7, 10
Line 1,084: Line 1,092:
 
**≥ 0.6 m<sup>2</sup> BSA: 960 mg/m<sup>2</sup> IV over 15 to 30 minutes immediately before [[Cyclophosphamide (Cytoxan)]] infusion, and again 4 and 8 hours after the start of [[Cyclophosphamide (Cytoxan)]] infusion
 
**≥ 0.6 m<sup>2</sup> BSA: 960 mg/m<sup>2</sup> IV over 15 to 30 minutes immediately before [[Cyclophosphamide (Cytoxan)]] infusion, and again 4 and 8 hours after the start of [[Cyclophosphamide (Cytoxan)]] infusion
 
***[[Mesna (Mesnex)]] can also be given PO at twice the IV dose
 
***[[Mesna (Mesnex)]] can also be given PO at twice the IV dose
 +
</div></div><br>
 +
<div class="toccolours" style="background-color:#eeeeee">
 
===Protocol, Cycles 5-8 (Weeks 13 through 24)===
 
===Protocol, Cycles 5-8 (Weeks 13 through 24)===
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
====Chemotherapy====
−
 
 
*[[Vincristine (Oncovin)]] by the following BSA-based criteria:
 
*[[Vincristine (Oncovin)]] by the following BSA-based criteria:
 
**0.25-0.29 m<sup>2</sup> BSA: 0.24 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 13 through 22
 
**0.25-0.29 m<sup>2</sup> BSA: 0.24 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 13 through 22
Line 1,096: Line 1,106:
 
**0.55-0.59 m<sup>2</sup> BSA: 0.8 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 13 through 22
 
**0.55-0.59 m<sup>2</sup> BSA: 0.8 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 13 through 22
 
**≥ 0.6 m<sup>2</sup> BSA: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 13 through 22
 
**≥ 0.6 m<sup>2</sup> BSA: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 13 through 22
−
 
 
*[[Dactinomycin (Cosmegen)]] by the following weight-based criteria:
 
*[[Dactinomycin (Cosmegen)]] by the following weight-based criteria:
 
**3-4.5 kg: 0.09 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 13, 16, 19, 22
 
**3-4.5 kg: 0.09 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 13, 16, 19, 22
Line 1,107: Line 1,116:
 
**12.6-13.9 kg: 0.6 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 13, 16, 19, 22
 
**12.6-13.9 kg: 0.6 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 13, 16, 19, 22
 
**≥14 kg: 0.05 mg/kg (maximum dose of 2.5 mg) slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 13, 16, 19, 22
 
**≥14 kg: 0.05 mg/kg (maximum dose of 2.5 mg) slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 13, 16, 19, 22
−
 
+
</div></div></div>
 
===References===
 
===References===
−
# '''Vinorelbine and low dose cyclophosphamide maintenance therapy:''' Vinorelbine and low dose cyclophosphamide maintenance therapy: Bisogno G, De Salvo GL, Bergeron C, Gallego Melcons s, Merks JH, Kelsey A, Martelli H, Minard-Colin V, Orbach D, Glosli H, Chisholm J, Casanova M, Zanetti I, Devalck C, Ben-Arush M, Mudry P, Ferman S, Jenney M, Ferrari A. Vinorelbine and continuous low-dose cyclophosphamide as maintenance chemotherapy in patients with high-risk rhabdomyosarcoma (RMS 2005): a multicentre, open-label, randomised, phase 3 tial. Lancet Oncol. 2019 Nov;20(11):1566-1575. [https://doi.org/10.1016/S1470-2045(19)30617-5 link to original article] [https://pubmed.ncbi.nlm.nih.gov/31562043/ PubMed]
 
 
# '''COG ARST1431:''' [https://clinicaltrials.gov/ct2/show/NCT02567435 NCT02567435]
 
# '''COG ARST1431:''' [https://clinicaltrials.gov/ct2/show/NCT02567435 NCT02567435]
−
 
+
==COG ARST0331 protocol==
−
==COG ARST0331 (In Process)==
+
In process
−
 
+
</div></div>
 +
===References===
 +
# '''COG ARST0331:''' NCT00075582
 
=High Risk=
 
=High Risk=
−
==COG ARST0431==
+
==COG ARST0431 protocol==
−
 
+
<div class="toccolours" style="background-color:#c8a2c8">
 +
{| class="wikitable sortable" style="width: 60%; text-align:center;"
 +
!style="width: 33%"|Study
 +
!style="width: 33%"|Years of enrollment
 +
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 +
|-
 +
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5070550/ Weigel et al. 2015 (COG ARST0431)]
 +
|7/17/2006-6/13/2008
 +
| style="background-color:#91cf61" |Non-randomized
 +
|-
 +
|}
 +
<div class="toccolours" style="background-color:#eeeeee">
 
===Protocol, Weeks 1-6===
 
===Protocol, Weeks 1-6===
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy, Week 1 (IRIN-VCR)====
 
====Chemotherapy, Week 1 (IRIN-VCR)====
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
Line 1,125: Line 1,147:
 
***Administer [[Vincristine (Oncovin)]] before [[Irinotecan (Camptosar)]]
 
***Administer [[Vincristine (Oncovin)]] before [[Irinotecan (Camptosar)]]
 
*[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 100 mg/day) IV over 60 minutes once per day on days 1 through 5
 
*[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 100 mg/day) IV over 60 minutes once per day on days 1 through 5
−
 
 
====Chemotherapy, Week 2 (VCR)====
 
====Chemotherapy, Week 2 (VCR)====
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
Line 1,143: Line 1,164:
 
***Administer [[Vincristine (Oncovin)]] before [[Irinotecan (Camptosar)]]
 
***Administer [[Vincristine (Oncovin)]] before [[Irinotecan (Camptosar)]]
 
*[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 100 mg/day) IV over 60 minutes once per day on days 1 through 5
 
*[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 100 mg/day) IV over 60 minutes once per day on days 1 through 5
−
 
 
====Chemotherapy, Week 5 (VCR)====
 
====Chemotherapy, Week 5 (VCR)====
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
Line 1,150: Line 1,170:
 
**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
 
====Chemotherapy, Week 6 Evaluation====
 
====Chemotherapy, Week 6 Evaluation====
−
 
+
</div></div><br>
 +
<div class="toccolours" style="background-color:#eeeeee">
 
===Protocol, Weeks 7-19===
 
===Protocol, Weeks 7-19===
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy, Week 7 (VDC)====
 
====Chemotherapy, Week 7 (VDC)====
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
Line 1,183: Line 1,205:
 
**Age ≥ 3 years: 360 mg/m<sup>2</sup> at hour 0, 4, and 8 from the start of each [[Ifosfamide (Ifex)]] infusion on days 1 through 5
 
**Age ≥ 3 years: 360 mg/m<sup>2</sup> at hour 0, 4, and 8 from the start of each [[Ifosfamide (Ifex)]] infusion on days 1 through 5
 
**Age < 3 years: 180 mg/m<sup>2</sup> at hour 0, 4, and 8 from the start of each [[Ifosfamide (Ifex)]] infusion on days 1 through 5
 
**Age < 3 years: 180 mg/m<sup>2</sup> at hour 0, 4, and 8 from the start of each [[Ifosfamide (Ifex)]] infusion on days 1 through 5
−
 
 
====Chemotherapy, Week 10 Off Chemo====
 
====Chemotherapy, Week 10 Off Chemo====
−
 
 
====Chemotherapy, Week 11 (VDC)====
 
====Chemotherapy, Week 11 (VDC)====
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
Line 1,217: Line 1,237:
 
**Age ≥ 3 years: 360 mg/m<sup>2</sup> at hour 0, 4, and 8 from the start of each [[Ifosfamide (Ifex)]] infusion on days 1 through 5
 
**Age ≥ 3 years: 360 mg/m<sup>2</sup> at hour 0, 4, and 8 from the start of each [[Ifosfamide (Ifex)]] infusion on days 1 through 5
 
**Age < 3 years: 180 mg/m<sup>2</sup> at hour 0, 4, and 8 from the start of each [[Ifosfamide (Ifex)]] infusion on days 1 through 5
 
**Age < 3 years: 180 mg/m<sup>2</sup> at hour 0, 4, and 8 from the start of each [[Ifosfamide (Ifex)]] infusion on days 1 through 5
−
 
 
====Chemotherapy, Week 14 Off Chemo====
 
====Chemotherapy, Week 14 Off Chemo====
−
 
 
====Chemotherapy, Week 15 (VDC)====
 
====Chemotherapy, Week 15 (VDC)====
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
Line 1,251: Line 1,269:
 
**Age ≥ 3 years: 360 mg/m<sup>2</sup> at hour 0, 4, and 8 from the start of each [[Ifosfamide (Ifex)]] infusion on days 1 through 5
 
**Age ≥ 3 years: 360 mg/m<sup>2</sup> at hour 0, 4, and 8 from the start of each [[Ifosfamide (Ifex)]] infusion on days 1 through 5
 
**Age < 3 years: 180 mg/m<sup>2</sup> at hour 0, 4, and 8 from the start of each [[Ifosfamide (Ifex)]] infusion on days 1 through 5
 
**Age < 3 years: 180 mg/m<sup>2</sup> at hour 0, 4, and 8 from the start of each [[Ifosfamide (Ifex)]] infusion on days 1 through 5
−
 
 
====Chemotherapy, Week 18 Off Chemo====
 
====Chemotherapy, Week 18 Off Chemo====
−
 
 
====Chemotherapy, Week 19 Evaluation====
 
====Chemotherapy, Week 19 Evaluation====
−
 
+
</div></div><br>
−
 
+
<div class="toccolours" style="background-color:#eeeeee">
 
===Protocol, Weeks 20-34===
 
===Protocol, Weeks 20-34===
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy, Week 20 (IRIN-VCR)====
 
====Chemotherapy, Week 20 (IRIN-VCR)====
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
Line 1,288: Line 1,305:
 
**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
 
====Chemotherapy, Week 25 Off Chemo====
 
====Chemotherapy, Week 25 Off Chemo====
−
 
 
====Chemotherapy, Week 26 (IE)====
 
====Chemotherapy, Week 26 (IE)====
 
*[[Ifosfamide (Ifex)]] by the following age-based criteria:
 
*[[Ifosfamide (Ifex)]] by the following age-based criteria:
Line 1,300: Line 1,316:
 
**Age ≥ 3 years: 360 mg/m<sup>2</sup> at hour 0, 4, and 8 from the start of each [[Ifosfamide (Ifex)]] infusion on days 1 through 5
 
**Age ≥ 3 years: 360 mg/m<sup>2</sup> at hour 0, 4, and 8 from the start of each [[Ifosfamide (Ifex)]] infusion on days 1 through 5
 
**Age < 3 years: 180 mg/m<sup>2</sup> at hour 0, 4, and 8 from the start of each [[Ifosfamide (Ifex)]] infusion on days 1 through 5
 
**Age < 3 years: 180 mg/m<sup>2</sup> at hour 0, 4, and 8 from the start of each [[Ifosfamide (Ifex)]] infusion on days 1 through 5
−
 
 
====Chemotherapy, Week 27 Off Chemo====
 
====Chemotherapy, Week 27 Off Chemo====
−
 
 
====Chemotherapy, Week 28 (VDC)====
 
====Chemotherapy, Week 28 (VDC)====
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
Line 1,334: Line 1,348:
 
**Age ≥ 3 years: 360 mg/m<sup>2</sup> at hour 0, 4, and 8 from the start of each [[Ifosfamide (Ifex)]] infusion on days 1 through 5
 
**Age ≥ 3 years: 360 mg/m<sup>2</sup> at hour 0, 4, and 8 from the start of each [[Ifosfamide (Ifex)]] infusion on days 1 through 5
 
**Age < 3 years: 180 mg/m<sup>2</sup> at hour 0, 4, and 8 from the start of each [[Ifosfamide (Ifex)]] infusion on days 1 through 5
 
**Age < 3 years: 180 mg/m<sup>2</sup> at hour 0, 4, and 8 from the start of each [[Ifosfamide (Ifex)]] infusion on days 1 through 5
−
 
 
====Chemotherapy, Week 31 Off Chemo====
 
====Chemotherapy, Week 31 Off Chemo====
−
 
 
====Chemotherapy, Week 32 (VDC)====
 
====Chemotherapy, Week 32 (VDC)====
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
Line 1,358: Line 1,370:
 
**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
 
====Chemotherapy, Week 34 Evaluation====
 
====Chemotherapy, Week 34 Evaluation====
−
 
+
</div></div><br>
−
 
+
<div class="toccolours" style="background-color:#eeeeee">
−
 
 
 
===Protocol, Weeks 35-54===
 
===Protocol, Weeks 35-54===
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy, Week 35 (VAC)====
 
====Chemotherapy, Week 35 (VAC)====
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
Line 1,378: Line 1,390:
 
**Age < 3 years: 8 mg/kg at hour 0, 4, and 8 from the start of each [[Cyclophosphamide (Cytoxan)]] infusion on days 1
 
**Age < 3 years: 8 mg/kg at hour 0, 4, and 8 from the start of each [[Cyclophosphamide (Cytoxan)]] infusion on days 1
 
====Chemotherapy, Week 36 Off Chemo====
 
====Chemotherapy, Week 36 Off Chemo====
−
 
 
====Chemotherapy, Week 37 Off Chemo====
 
====Chemotherapy, Week 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:
Line 1,397: Line 1,407:
 
**Age < 3 years: 8 mg/kg at hour 0, 4, and 8 from the start of each [[Cyclophosphamide (Cytoxan)]] infusion on days 1
 
**Age < 3 years: 8 mg/kg at hour 0, 4, and 8 from the start of each [[Cyclophosphamide (Cytoxan)]] infusion on days 1
 
====Chemotherapy, Week 39 Off Chemo====
 
====Chemotherapy, Week 39 Off Chemo====
−
 
 
====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:
Line 1,441: Line 1,449:
 
**Age < 3 years: 8 mg/kg at hour 0, 4, and 8 from the start of each [[Cyclophosphamide (Cytoxan)]] infusion on days 1
 
**Age < 3 years: 8 mg/kg at hour 0, 4, and 8 from the start of each [[Cyclophosphamide (Cytoxan)]] infusion on days 1
 
====Chemotherapy, Week 45 Off Chemo====
 
====Chemotherapy, Week 45 Off Chemo====
−
 
 
====Chemotherapy, Week 46 Off Chemo====
 
====Chemotherapy, Week 46 Off Chemo====
−
 
 
====Chemotherapy, Week 47 (IRIN-VCR)====
 
====Chemotherapy, Week 47 (IRIN-VCR)====
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
Line 1,457: Line 1,463:
 
**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
 
====Chemotherapy, Week 49 Off Chemo====
 
====Chemotherapy, Week 49 Off Chemo====
−
 
 
====Chemotherapy, Week 50 (IRIN-VCR)====
 
====Chemotherapy, Week 50 (IRIN-VCR)====
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
 
*[[Vincristine (Oncovin)]] by the following age-based criteria:
Line 1,471: Line 1,476:
 
**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
 
====Chemotherapy, Week 52 Off Chemo====
 
====Chemotherapy, Week 52 Off Chemo====
−
 
 
====Chemotherapy, Week 53 Off Chemo====
 
====Chemotherapy, Week 53 Off Chemo====
−
 
 
====Chemotherapy, Week 54 Evaluation====
 
====Chemotherapy, Week 54 Evaluation====
−
 
+
</div></div></div>
−
 
 
 
===References===
 
===References===
−
# '''COG ARST0431:''' Weigel BJ, Lyden E, Anderson JR, Meyer WH, Parham DM, Rodeberg DA, Michalski JM, Hawkins DS, Arndt CAS. Intensive Multiagent Therapy, Including Dose-Compressed Cycles of Ifosfamide/Etoposide and Vincristine/Doxorubicin/Cyclophosphamide, Irinotecan, and Radiation, in Patients with High-Risk Rhabdomyosarcoma: A Report from the Children's Oncology Group. Journal of Clinical Oncology. 2016 Oct;34(2):117-122. [https://doi.org/10.1200/jco.2015.63.4048 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5070550/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/26503200/ PubMed] NCT00354744
+
# '''COG ARST0431:''' Weigel BJ, Lyden E, Anderson JR, Meyer WH, Parham DM, Rodeberg DA, Michalski JM, Hawkins DS, Arndt CAS. Intensive Multiagent Therapy, Including Dose-Compressed Cycles of Ifosfamide/Etoposide and Vincristine/Doxorubicin/Cyclophosphamide, Irinotecan, and Radiation, in Patients with High-Risk Rhabdomyosarcoma: A Report from the Children's Oncology Group. Journal of Clinical Oncology. 2016 Oct;34(2):117-122. Epub 2015 Oct 26. [https://doi.org/10.1200/jco.2015.63.4048 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5070550/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/26503200/ PubMed] NCT00354744
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[[Category:Disease-specific pages]]
 
[[Category:Disease-specific pages]]
 
[[Category:Bone sarcomas]]
 
[[Category:Bone sarcomas]]
 
[[Category:Pediatric solid tumors]]
 
[[Category:Pediatric solid tumors]]

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Intermediate Risk

COG ARST1431 Protocol A (VAC/VI Only)

Study Years of enrollment Evidence Comparator Comparative Efficacy
Awaiting publication (COG ARST1431) 2016-2025 Phase 3 (C) VAC/VI & Temsirolimus TBD

Protocol, Cycles 1-4 (Weeks 1 through 12)

Chemotherapy

  • Vincristine (Oncovin) by the following BSA-based criteria:
    • 0.25-0.29 m2 BSA: 0.24 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 1 through 12
    • 0.3-0.34 m2 BSA: 0.34 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 1 through 12
    • 0.35-0.39 m2 BSA: 0.44 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 1 through 12
    • 0.4-0.44 m2 BSA: 0.55 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 1 through 12
    • 0.45-0.49 m2 BSA: 0.65 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 1 through 12
    • 0.5-0.54 m2 BSA: 0.74 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 1 through 12
    • 0.55-0.59 m2 BSA: 0.8 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 1 through 12
    • ≥ 0.6 m2 BSA: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 1 through 12
  • Dactinomycin (Cosmegen) by the following weight-based criteria:
    • 3-4.5 kg: 0.09 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 1 and 7
    • 4.6-6 kg: 0.14 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 1 and 7
    • 6.1-7.3 kg: 0.21 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 1 and 7
    • 7.4-8.6 kg: 0.26 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 1 and 7
    • 8.7-9.9 kg: 0.33 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 1 and 7
    • 10-11.2 kg: 0.4 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 1 and 7
    • 11.3-12.5 kg: 0.5 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 1 and 7
    • 12.6-13.9 kg: 0.6 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 1 and 7
    • ≥14 kg: 0.05 mg/kg (maximum dose of 2.5 mg) slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 1 and 7
  • Cyclophosphamide (Cytoxan) by the following BSA-based criteria:
    • 0.25-0.29 m2 BSA: 220 mg IV over 60 minutes on day 1 of weeks 1 and 7
    • 0.3-0.34 m2 BSA: 280 mg IV over 60 minutes on day 1 of weeks 1 and 7
    • 0.35-0.39 m2 BSA: 360 mg IV over 60 minutes on day 1 of weeks 1 and 7
    • 0.4-0.44 m2 BSA: 440 mg IV over 60 minutes on day 1 of weeks 1 and 7
    • 0.45-0.49 m2 BSA: 520 mg IV over 60 minutes on day 1 of weeks 1 and 7
    • 0.5-0.54 m2 BSA: 600 mg IV over 60 minutes on day 1 of weeks 1 and 7
    • 0.55-0.59 m2 BSA: 660 mg IV over 60 minutes on day 1 of weeks 1 and 7
    • ≥ 0.6 m2 BSA: 1200 mg/m2 IV over 60 minutes on day 1 of weeks 1 and 7
  • Irinotecan (Camptosar) by the following BSA-based criteria:
    • 0.25-0.29 m2 BSA: 8 mg IV over 90 minutes once daily on days 1 through 5 of weeks 4 and 10
    • 0.3-0.34 m2 BSA: 12 mg IV over 90 minutes once daily on days 1 through 5 of weeks 4 and 10
    • 0.35-0.39 m2 BSA: 15 mg IV over 90 minutes once daily on days 1 through 5 of weeks 4 and 10
    • 0.4-0.44 m2 BSA: 18 mg IV over 90 minutes once daily on days 1 through 5 of weeks 4 and 10
    • 0.45-0.49 m2 BSA: 22 mg IV over 90 minutes once daily on days 1 through 5 of weeks 4 and 10
    • 0.5-0.54 m2 BSA: 24 mg IV over 90 minutes once daily on days 1 through 5 of weeks 4 and 10
    • 0.55-0.59 m2 BSA: 28 mg IV over 90 minutes once daily on days 1 through 5 of weeks 4 and 10
    • ≥ 0.6 m2 BSA: 50 mg/m2 IV over 90 minutes once daily on days 1 through 5 of weeks 4 and 10

Supportive Medications


Protocol, Cycles 5-10 (Weeks 13 through 30)

Chemotherapy

  • Vincristine (Oncovin) by the following BSA-based criteria:
    • 0.25-0.29 m2 BSA: 0.24 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 13, 16, 17, 19, 20, 22 through 26, 28
    • 0.3-0.34 m2 BSA: 0.34 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 13, 16, 17, 19, 20, 22 through 26, 28
    • 0.35-0.39 m2 BSA: 0.44 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 13, 16, 17, 19, 20, 22 through 26, 28
    • 0.4-0.44 m2 BSA: 0.55 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 13, 16, 17, 19, 20, 22 through 26, 28
    • 0.45-0.49 m2 BSA: 0.65 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 13, 16, 17, 19, 20, 22 through 26, 28
    • 0.5-0.54 m2 BSA: 0.74 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 13, 16, 17, 19, 20, 22 through 26, 28
    • 0.55-0.59 m2 BSA: 0.8 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 13, 16, 17, 19, 20, 22 through 26, 28
    • ≥ 0.6 m2 BSA: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 13, 16, 17, 19, 20, 22 through 26, 28
  • Dactinomycin (Cosmegen) by the following weight-based criteria:
    • 3-4.5 kg: 0.09 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 13, 22, 28
    • 4.6-6 kg: 0.14 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 13, 22, 28
    • 6.1-7.3 kg: 0.21 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 13, 22, 28
    • 7.4-8.6 kg: 0.26 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 13, 22, 28
    • 8.7-9.9 kg: 0.33 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 13, 22, 28
    • 10-11.2 kg: 0.4 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 13, 22, 28
    • 11.3-12.5 kg: 0.5 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 13, 22, 28
    • 12.6-13.9 kg: 0.6 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 13, 22, 28
    • ≥14 kg: 0.05 mg/kg (maximum dose of 2.5 mg) slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 13, 22, 28
  • Cyclophosphamide (Cytoxan) by the following BSA-based criteria:
    • 0.25-0.29 m2 BSA: 220 mg IV over 60 minutes on day 1 of weeks 13, 22, 28
    • 0.3-0.34 m2 BSA: 280 mg IV over 60 minutes on day 1 of weeks 13, 22, 28
    • 0.35-0.39 m2 BSA: 360 mg IV over 60 minutes on day 1 of weeks 13, 22, 28
    • 0.4-0.44 m2 BSA: 440 mg IV over 60 minutes on day 1 of weeks 13, 22, 28
    • 0.45-0.49 m2 BSA: 520 mg IV over 60 minutes on day 1 of weeks 13, 22, 28
    • 0.5-0.54 m2 BSA: 600 mg IV over 60 minutes on day 1 of weeks 13, 22, 28
    • 0.55-0.59 m2 BSA: 660 mg IV over 60 minutes on day 1 of weeks 13, 22, 28
    • ≥ 0.6 m2 BSA: 1200 mg/m2 IV over 60 minutes on day 1 of weeks 13, 22, 28
  • Irinotecan (Camptosar) by the following BSA-based criteria:
    • 0.25-0.29 m2 BSA: 8 mg IV over 90 minutes once daily on days 1 through 5 of weeks 16, 19, 25
    • 0.3-0.34 m2 BSA: 12 mg IV over 90 minutes once daily on days 1 through 5 of weeks 16, 19, 25
    • 0.35-0.39 m2 BSA: 15 mg IV over 90 minutes once daily on days 1 through 5 of weeks 16, 19, 25
    • 0.4-0.44 m2 BSA: 18 mg IV over 90 minutes once daily on days 1 through 5 of weeks 16, 19, 25
    • 0.45-0.49 m2 BSA: 22 mg IV over 90 minutes once daily on days 1 through 5 of weeks 16, 19, 25
    • 0.5-0.54 m2 BSA: 24 mg IV over 90 minutes once daily on days 1 through 5 of weeks 16, 19, 25
    • 0.55-0.59 m2 BSA: 28 mg IV over 90 minutes once daily on days 1 through 5 of weeks 16, 19, 25
    • ≥ 0.6 m2 BSA: 50 mg/m2 IV over 90 minutes once daily on days 1 through 5 of weeks 16, 19, 25

Supportive Medications


Protocol, Cycles 11-14 (Weeks 31 through 42)

Chemotherapy

  • Vincristine (Oncovin) by the following BSA-based criteria:
    • 0.25-0.29 m2 BSA: 0.24 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 31 through 34, 37, 38, 40
    • 0.3-0.34 m2 BSA: 0.34 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 31 through 34, 37, 38, 40
    • 0.35-0.39 m2 BSA: 0.44 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 31 through 34, 37, 38, 40
    • 0.4-0.44 m2 BSA: 0.55 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 31 through 34, 37, 38, 40
    • 0.45-0.49 m2 BSA: 0.65 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 31 through 34, 37, 38, 40
    • 0.5-0.54 m2 BSA: 0.74 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 31 through 34, 37, 38, 40
    • 0.55-0.59 m2 BSA: 0.8 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 31 through 34, 37, 38, 40
    • ≥ 0.6 m2 BSA: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 31 through 34, 37, 38, 40
  • Dactinomycin (Cosmegen) by the following weight-based criteria:
    • 3-4.5 kg: 0.09 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 34, 40
    • 4.6-6 kg: 0.14 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 34, 40
    • 6.1-7.3 kg: 0.21 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 34, 40
    • 7.4-8.6 kg: 0.26 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 34, 40
    • 8.7-9.9 kg: 0.33 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 34, 40
    • 10-11.2 kg: 0.4 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 34, 40
    • 11.3-12.5 kg: 0.5 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 34, 40
    • 12.6-13.9 kg: 0.6 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 34, 40
    • ≥14 kg: 0.05 mg/kg (maximum dose of 2.5 mg) slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 34, 40
  • Cyclophosphamide (Cytoxan) by the following BSA-based criteria:
    • 0.25-0.29 m2 BSA: 220 mg IV over 60 minutes on day 1 of weeks 34, 40
    • 0.3-0.34 m2 BSA: 280 mg IV over 60 minutes on day 1 of weeks 34, 40
    • 0.35-0.39 m2 BSA: 360 mg IV over 60 minutes on day 1 of weeks 34, 40
    • 0.4-0.44 m2 BSA: 440 mg IV over 60 minutes on day 1 of weeks 34, 40
    • 0.45-0.49 m2 BSA: 520 mg IV over 60 minutes on day 1 of weeks 34, 40
    • 0.5-0.54 m2 BSA: 600 mg IV over 60 minutes on day 1 of weeks 34, 40
    • 0.55-0.59 m2 BSA: 660 mg IV over 60 minutes on day 1 of weeks 34, 40
    • ≥ 0.6 m2 BSA: 1200 mg/m2 IV over 60 minutes on day 1 of weeks 34, 40
  • Irinotecan (Camptosar) by the following BSA-based criteria:
    • 0.25-0.29 m2 BSA: 8 mg IV over 90 minutes once daily on days 1 through 5 of weeks 31, 37
    • 0.3-0.34 m2 BSA: 12 mg IV over 90 minutes once daily on days 1 through 5 of weeks 31, 37
    • 0.35-0.39 m2 BSA: 15 mg IV over 90 minutes once daily on days 1 through 5 of weeks 31, 37
    • 0.4-0.44 m2 BSA: 18 mg IV over 90 minutes once daily on days 1 through 5 of weeks 31, 37
    • 0.45-0.49 m2 BSA: 22 mg IV over 90 minutes once daily on days 1 through 5 of weeks 31, 37
    • 0.5-0.54 m2 BSA: 24 mg IV over 90 minutes once daily on days 1 through 5 of weeks 31, 37
    • 0.55-0.59 m2 BSA: 28 mg IV over 90 minutes once daily on days 1 through 5 of weeks 31, 37
    • ≥ 0.6 m2 BSA: 50 mg/m2 IV over 90 minutes once daily on days 1 through 5 of weeks 31, 37

Supportive Medications


Protocol, Maintenance Cycles 1-6

Chemotherapy

  • Vinorelbine (Navelbine) by the following BSA-based criteria:
    • 0.25-0.29 m2 BSA: 4 mg IV push over 6 to 10 minutes on days 1, 8, and 15
    • 0.3-0.34 m2 BSA: 6 mg IV push over 6 to 10 minutes on days 1, 8, and 15
    • 0.35-0.39 m2 BSA: 7.5 mg IV push over 6 to 10 minutes on days 1, 8, and 15
    • 0.4-0.44 m2 BSA: 9 mg IV push over 6 to 10 minutes on days 1, 8, and 15
    • 0.45-0.49 m2 BSA: 11 mg IV push over 6 to 10 minutes on days 1, 8, and 15
    • 0.5-0.54 m2 BSA: 12 mg IV push over 6 to 10 minutes on days 1, 8, and 15
    • 0.55-0.59 m2 BSA: 14 mg IV push over 6 to 10 minutes on days 1, 8, and 15
    • ≥ 0.6 m2 BSA: 25 mg/m2 IV push over 6 to 10 minutes on days 1, 8, and 15
  • Cyclophosphamide (Cytoxan) 25 mg/m2 PO once daily on days 1 through 28
    • Dose rounded to the nearest 25 mg capsule

28-day cycle

References

  1. COG ARST1431: NCT02567435

COG ARST1431 Protocol B (VAC/VI & Temsirolimus)

Study Years of enrollment Evidence Comparator Comparative Efficacy
Awaiting publication (COG ARST1431) 2016-2025 Phase 3 (E-esc) VAC/VI TBD if superior EFS (primary endpoint)

Protocol, Cycles 1-4 (Weeks 1 through 12)

Chemotherapy

  • Temsirolimus (Torisel) by the following weight-based criteria:
    • < 10 kg: 0.5 mg/kg IV over 30 to 60 minutes once weekly on day 1 of weeks 1 through 12
    • > 10 kg: 15 mg/m2 (maximum dose of 25 mg) IV on day 1 of weeks 1 through 12
  • Vincristine (Oncovin) by the following BSA-based criteria:
    • 0.25-0.29 m2 BSA: 0.24 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 1 through 12
    • 0.3-0.34 m2 BSA: 0.34 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 1 through 12
    • 0.35-0.39 m2 BSA: 0.44 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 1 through 12
    • 0.4-0.44 m2 BSA: 0.55 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 1 through 12
    • 0.45-0.49 m2 BSA: 0.65 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 1 through 12
    • 0.5-0.54 m2 BSA: 0.74 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 1 through 12
    • 0.55-0.59 m2 BSA: 0.8 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 1 through 12
    • ≥ 0.6 m2 BSA: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 1 through 12
  • Dactinomycin (Cosmegen) by the following weight-based criteria:
    • 3-4.5 kg: 0.09 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 1 and 7
    • 4.6-6 kg: 0.14 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 1 and 7
    • 6.1-7.3 kg: 0.21 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 1 and 7
    • 7.4-8.6 kg: 0.26 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 1 and 7
    • 8.7-9.9 kg: 0.33 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 1 and 7
    • 10-11.2 kg: 0.4 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 1 and 7
    • 11.3-12.5 kg: 0.5 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 1 and 7
    • 12.6-13.9 kg: 0.6 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 1 and 7
    • ≥14 kg: 0.05 mg/kg (maximum dose of 2.5 mg) slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 1 and 7
  • Cyclophosphamide (Cytoxan) by the following BSA-based criteria:
    • 0.25-0.29 m2 BSA: 220 mg IV over 60 minutes on day 1 of weeks 1 and 7
    • 0.3-0.34 m2 BSA: 280 mg IV over 60 minutes on day 1 of weeks 1 and 7
    • 0.35-0.39 m2 BSA: 360 mg IV over 60 minutes on day 1 of weeks 1 and 7
    • 0.4-0.44 m2 BSA: 440 mg IV over 60 minutes on day 1 of weeks 1 and 7
    • 0.45-0.49 m2 BSA: 520 mg IV over 60 minutes on day 1 of weeks 1 and 7
    • 0.5-0.54 m2 BSA: 600 mg IV over 60 minutes on day 1 of weeks 1 and 7
    • 0.55-0.59 m2 BSA: 660 mg IV over 60 minutes on day 1 of weeks 1 and 7
    • ≥ 0.6 m2 BSA: 1200 mg/m2 IV over 60 minutes on day 1 of weeks 1 and 7
  • Irinotecan (Camptosar) by the following BSA-based criteria:
    • 0.25-0.29 m2 BSA: 8 mg IV over 90 minutes once daily on days 1 through 5 of weeks 4 and 10
    • 0.3-0.34 m2 BSA: 12 mg IV over 90 minutes once daily on days 1 through 5 of weeks 4 and 10
    • 0.35-0.39 m2 BSA: 15 mg IV over 90 minutes once daily on days 1 through 5 of weeks 4 and 10
    • 0.4-0.44 m2 BSA: 18 mg IV over 90 minutes once daily on days 1 through 5 of weeks 4 and 10
    • 0.45-0.49 m2 BSA: 22 mg IV over 90 minutes once daily on days 1 through 5 of weeks 4 and 10
    • 0.5-0.54 m2 BSA: 24 mg IV over 90 minutes once daily on days 1 through 5 of weeks 4 and 10
    • 0.55-0.59 m2 BSA: 28 mg IV over 90 minutes once daily on days 1 through 5 of weeks 4 and 10
    • ≥ 0.6 m2 BSA: 50 mg/m2 IV over 90 minutes once daily on days 1 through 5 of weeks 4 and 10

Supportive Medications

Mesna (Mesnex) can also be given PO at twice the IV dose

Protocol, Cycles 5-10 (Weeks 13 through 30)

Chemotherapy

  • Temsirolimus (Torisel) by the following weight-based criteria:
    • < 10 kg: 0.5 mg/kg IV over 30 to 60 minutes once weekly on day 1 of weeks 21 through 30
    • > 10 kg: 15 mg/m2 (maximum dose of 25 mg) IV on day 1 of weeks 21 through 30
  • Vincristine (Oncovin) by the following BSA-based criteria:
    • 0.25-0.29 m2 BSA: 0.24 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 13, 16, 17, 19, 20, 22 through 26, 28
    • 0.3-0.34 m2 BSA: 0.34 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 13, 16, 17, 19, 20, 22 through 26, 28
    • 0.35-0.39 m2 BSA: 0.44 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 13, 16, 17, 19, 20, 22 through 26, 28
    • 0.4-0.44 m2 BSA: 0.55 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 13, 16, 17, 19, 20, 22 through 26, 28
    • 0.45-0.49 m2 BSA: 0.65 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 13, 16, 17, 19, 20, 22 through 26, 28
    • 0.5-0.54 m2 BSA: 0.74 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 13, 16, 17, 19, 20, 22 through 26, 28
    • 0.55-0.59 m2 BSA: 0.8 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 13, 16, 17, 19, 20, 22 through 26, 28
    • ≥ 0.6 m2 BSA: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 13, 16, 17, 19, 20, 22 through 26, 28
  • Dactinomycin (Cosmegen) by the following weight-based criteria:
    • 3-4.5 kg: 0.09 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 13, 22, 28
    • 4.6-6 kg: 0.14 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 13, 22, 28
    • 6.1-7.3 kg: 0.21 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 13, 22, 28
    • 7.4-8.6 kg: 0.26 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 13, 22, 28
    • 8.7-9.9 kg: 0.33 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 13, 22, 28
    • 10-11.2 kg: 0.4 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 13, 22, 28
    • 11.3-12.5 kg: 0.5 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 13, 22, 28
    • 12.6-13.9 kg: 0.6 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 13, 22, 28
    • ≥14 kg: 0.05 mg/kg (maximum dose of 2.5 mg) slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 13, 22, 28
Give week 13 dose of Dactinomycin (Cosmegen) before beginning radiation therapy
  • Cyclophosphamide (Cytoxan) by the following BSA-based criteria:
    • 0.25-0.29 m2 BSA: 220 mg IV over 60 minutes on day 1 of weeks 13, 22, 28
    • 0.3-0.34 m2 BSA: 280 mg IV over 60 minutes on day 1 of weeks 13, 22, 28
    • 0.35-0.39 m2 BSA: 360 mg IV over 60 minutes on day 1 of weeks 13, 22, 28
    • 0.4-0.44 m2 BSA: 440 mg IV over 60 minutes on day 1 of weeks 13, 22, 28
    • 0.45-0.49 m2 BSA: 520 mg IV over 60 minutes on day 1 of weeks 13, 22, 28
    • 0.5-0.54 m2 BSA: 600 mg IV over 60 minutes on day 1 of weeks 13, 22, 28
    • 0.55-0.59 m2 BSA: 660 mg IV over 60 minutes on day 1 of weeks 13, 22, 28
    • ≥ 0.6 m2 BSA: 1200 mg/m2 IV over 60 minutes on day 1 of weeks 13, 22, 28
  • Irinotecan (Camptosar) by the following BSA-based criteria:
    • 0.25-0.29 m2 BSA: 8 mg IV over 90 minutes once daily on days 1 through 5 of weeks 16, 19, 25
    • 0.3-0.34 m2 BSA: 12 mg IV over 90 minutes once daily on days 1 through 5 of weeks 16, 19, 25
    • 0.35-0.39 m2 BSA: 15 mg IV over 90 minutes once daily on days 1 through 5 of weeks 16, 19, 25
    • 0.4-0.44 m2 BSA: 18 mg IV over 90 minutes once daily on days 1 through 5 of weeks 16, 19, 25
    • 0.45-0.49 m2 BSA: 22 mg IV over 90 minutes once daily on days 1 through 5 of weeks 16, 19, 25
    • 0.5-0.54 m2 BSA: 24 mg IV over 90 minutes once daily on days 1 through 5 of weeks 16, 19, 25
    • 0.55-0.59 m2 BSA: 28 mg IV over 90 minutes once daily on days 1 through 5 of weeks 16, 19, 25
    • ≥ 0.6 m2 BSA: 50 mg/m2 IV over 90 minutes once daily on days 1 through 5 of weeks 16, 19, 25

Supportive Medications

Mesna (Mesnex) can also be given PO at twice the IV dose

Protocol, Cycles 11-14 (Weeks 31 through 42)

Chemotherapy

  • Temsirolimus (Torisel) by the following weight-based criteria:
    • < 10 kg: 0.5 mg/kg IV over 30 to 60 minutes once weekly on day 1 of weeks 31 through 42
    • > 10 kg: 15 mg/m2 (maximum dose of 25 mg) IV on day 1 of weeks 31 through 42
  • Vincristine (Oncovin) by the following BSA-based criteria:
    • 0.25-0.29 m2 BSA: 0.24 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 31 through 34, 37, 38, 40
    • 0.3-0.34 m2 BSA: 0.34 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 31 through 34, 37, 38, 40
    • 0.35-0.39 m2 BSA: 0.44 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 31 through 34, 37, 38, 40
    • 0.4-0.44 m2 BSA: 0.55 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 31 through 34, 37, 38, 40
    • 0.45-0.49 m2 BSA: 0.65 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 31 through 34, 37, 38, 40
    • 0.5-0.54 m2 BSA: 0.74 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 31 through 34, 37, 38, 40
    • 0.55-0.59 m2 BSA: 0.8 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 31 through 34, 37, 38, 40
    • ≥ 0.6 m2 BSA: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 31 through 34, 37, 38, 40
  • Dactinomycin (Cosmegen) by the following weight-based criteria:
    • 3-4.5 kg: 0.09 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 34, 40
    • 4.6-6 kg: 0.14 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 34, 40
    • 6.1-7.3 kg: 0.21 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 34, 40
    • 7.4-8.6 kg: 0.26 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 34, 40
    • 8.7-9.9 kg: 0.33 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 34, 40
    • 10-11.2 kg: 0.4 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 34, 40
    • 11.3-12.5 kg: 0.5 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 34, 40
    • 12.6-13.9 kg: 0.6 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 34, 40
    • ≥14 kg: 0.05 mg/kg (maximum dose of 2.5 mg) slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 34, 40
  • Cyclophosphamide (Cytoxan) by the following BSA-based criteria:
    • 0.25-0.29 m2 BSA: 220 mg IV over 60 minutes on day 1 of weeks 34, 40
    • 0.3-0.34 m2 BSA: 280 mg IV over 60 minutes on day 1 of weeks 34, 40
    • 0.35-0.39 m2 BSA: 360 mg IV over 60 minutes on day 1 of weeks 34, 40
    • 0.4-0.44 m2 BSA: 440 mg IV over 60 minutes on day 1 of weeks 34, 40
    • 0.45-0.49 m2 BSA: 520 mg IV over 60 minutes on day 1 of weeks 34, 40
    • 0.5-0.54 m2 BSA: 600 mg IV over 60 minutes on day 1 of weeks 34, 40
    • 0.55-0.59 m2 BSA: 660 mg IV over 60 minutes on day 1 of weeks 34, 40
    • ≥ 0.6 m2 BSA: 1200 mg/m2 IV over 60 minutes on day 1 of weeks 34, 40
  • Irinotecan (Camptosar) by the following BSA-based criteria:
    • 0.25-0.29 m2 BSA: 8 mg IV over 90 minutes once daily on days 1 through 5 of weeks 31, 37
    • 0.3-0.34 m2 BSA: 12 mg IV over 90 minutes once daily on days 1 through 5 of weeks 31, 37
    • 0.35-0.39 m2 BSA: 15 mg IV over 90 minutes once daily on days 1 through 5 of weeks 31, 37
    • 0.4-0.44 m2 BSA: 18 mg IV over 90 minutes once daily on days 1 through 5 of weeks 31, 37
    • 0.45-0.49 m2 BSA: 22 mg IV over 90 minutes once daily on days 1 through 5 of weeks 31, 37
    • 0.5-0.54 m2 BSA: 24 mg IV over 90 minutes once daily on days 1 through 5 of weeks 31, 37
    • 0.55-0.59 m2 BSA: 28 mg IV over 90 minutes once daily on days 1 through 5 of weeks 31, 37
    • ≥ 0.6 m2 BSA: 50 mg/m2 IV over 90 minutes once daily on days 1 through 5 of weeks 31, 37

Supportive Medications

Mesna (Mesnex) can also be given PO at twice the IV dose

Protocol, Maintenance Cycles 1-6

Chemotherapy

  • Vinorelbine (Navelbine) by the following BSA-based criteria:
    • 0.25-0.29 m2 BSA: 4 mg IV push over 6 to 10 minutes on days 1, 8, and 15
    • 0.3-0.34 m2 BSA: 6 mg IV push over 6 to 10 minutes on days 1, 8, and 15
    • 0.35-0.39 m2 BSA: 7.5 mg IV push over 6 to 10 minutes on days 1, 8, and 15
    • 0.4-0.44 m2 BSA: 9 mg IV push over 6 to 10 minutes on days 1, 8, and 15
    • 0.45-0.49 m2 BSA: 11 mg IV push over 6 to 10 minutes on days 1, 8, and 15
    • 0.5-0.54 m2 BSA: 12 mg IV push over 6 to 10 minutes on days 1, 8, and 15
    • 0.55-0.59 m2 BSA: 14 mg IV push over 6 to 10 minutes on days 1, 8, and 15
    • ≥ 0.6 m2 BSA: 25 mg/m2 IV push over 6 to 10 minutes on days 1, 8, and 15
  • Cyclophosphamide (Cytoxan) 25 mg/m2 PO once daily on days 1 through 28
    • Dose rounded to the nearest 25 mg capsule

28-day cycle

References

  1. COG ARST1431: NCT02567435

COG ARST0531 VAC Arm

Study Years of enrollment Evidence Comparator Comparative Efficacy
Hawkins et al. 2018 (COG ARST0531) 2006-2012 Phase 3 (C) VAC/VI Did not meet primary endpoint of EFS

Protocol, Weeks 1-15

Study Years of enrollment Evidence Comparator Comparative Efficacy
Hawkins et al. 2018 (COG ARST0531) 2006-2012 Phase 3 (E-switch-ic) VAC/VI Did not meet primary endpoint of EFS

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
  • 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: 1200 mg/m2 IV over 1 hour once per day on day 1
    • Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1

Supportive Medications, Week 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

Chemotherapy, Week 4

  • Radiation therapy begins
  • 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: 1200 mg/m2 IV over 1 hour once per day on day 1
    • Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1

Supportive Medications, Week 4

Chemotherapy, Week 5

  • Radiation therapy continues
  • 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

  • Radiation therapy continues
  • 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

  • Radiation therapy continues
  • 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: 1200 mg/m2 IV over 1 hour once per day on day 1
    • Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1

Supportive Medications, Week 7

Chemotherapy, Week 8

  • Radiation therapy continues
  • 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

  • Radiation therapy final 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

Chemotherapy, Week 10

  • 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: 1200 mg/m2 IV over 1 hour once per day on day 1
    • Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1

Supportive Medications, Week 10

Chemotherapy, Week 11

  • 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 12

  • 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 13

  • 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: 1200 mg/m2 IV over 1 hour once per day on day 1
    • Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1

Supportive Medications, Week 13

Chemotherapy, Week 14 Off Chemo

Chemotherapy, Week 15 Evaluation


Protocol, Weeks 16-30

Chemotherapy, Week 16

  • 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: 1200 mg/m2 IV over 1 hour once per day on day 1
    • Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1

Supportive Medications, Week 16

Chemotherapy, Week 17 Off Chemo

Chemotherapy, Week 18 Off Chemo

Chemotherapy, Week 19

  • 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: 1200 mg/m2 IV over 1 hour once per day on day 1
    • Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1

Supportive Medications, Week 19

Chemotherapy, Week 20

  • 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 21

  • 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 22

  • 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: 1200 mg/m2 IV over 1 hour once per day on day 1
    • Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1

Supportive Medications, Week 22

Chemotherapy, Week 23

  • 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 24

  • 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 25

  • 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: 1200 mg/m2 IV over 1 hour once per day on day 1
    • Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1

Supportive Medications, Week 25

Chemotherapy, Week 26 Off Chemo

Chemotherapy, Week 27 Off Chemo

Chemotherapy, Week 28

  • 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: 1200 mg/m2 IV over 1 hour once per day on day 1
    • Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1

Supportive Medications, Week 28

Chemotherapy, Week 29 Off Chemo

Chemotherapy, Week 30 Evaluation


Protocol, Weeks 31-43

Chemotherapy, Week 31

  • 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: 1200 mg/m2 IV over 1 hour once per day on day 1
    • Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1

Supportive Medications, Week 31

Chemotherapy, Week 32

  • 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 33

  • 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 34

  • 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: 1200 mg/m2 IV over 1 hour once per day on day 1
    • Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1

Supportive Medications, Week 34

Chemotherapy, Week 35

  • 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 36

  • 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 37

  • 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: 1200 mg/m2 IV over 1 hour once per day on day 1
    • Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1

Supportive Medications, Week 37

Chemotherapy, Week 38 Off Chemo

Chemotherapy, Week 39 Off Chemo

Chemotherapy, Week 40

  • 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: 1200 mg/m2 IV over 1 hour once per day on day 1
    • Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1

Supportive Medications, Week 40

Chemotherapy, Week 41 Off Chemo

Chemotherapy, Week 42 Off Chemo

Chemotherapy, Week 43 Evaluation

References

  1. COG ARST0531: Hawkins DS, Chi Y, Anderson JR, Tian J, Arndt CAS, Bomgaars L, Donaldson SS, Hayes-Jordan A, Mascarenhas L, McCarville MB, McCune JS, McCowage G, Million L, Morris CD, Parham DM, Rodeberg DA, Rudzinski ER, Shnorhavorian M, Spunt SL, Skapek SX, Teot LA, Wolden S, Yock TI, Meyer WH. Addition of Vincristine and Irinotecan to Vincristine, Dactinomycin, and Cyclophosphamide Does Not Improve Outcome for Intermediate-Risk Rhabdomyosarcoma: A Report From the Children's Oncology Group. J Clin Oncol. 2018 Sep;36(27):2770-2777. Epub 2018 Aug 9. link to original article link to PMC article PubMed NCT01222715

COG ARST0531 VAC/VI Arm

Study Years of enrollment Evidence Comparator Comparative Efficacy
Hawkins et al. 2018 (COG ARST0531) 2006-2012 Phase 3 (E-switch-ic) VAC Did not meet primary endpoint of EFS
EFS48: 59% vs 63%

Protocol, Weeks 1-15

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
  • 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: 1200 mg/m2 IV over 1 hour once per day on day 1
    • Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1

Supportive Medications, Week 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

Chemotherapy, Week 4

  • Radiation therapy begins
  • 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 100 mg/day) IV over 90 minutes once per day on days 1 through 5

Chemotherapy, Week 5

  • Radiation therapy continues
  • 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

  • Radiation therapy continues
  • 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

  • Radiation therapy continues
  • 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 100 mg/day) IV over 90 minutes once per day on days 1 through 5

Chemotherapy, Week 8

  • Radiation therapy continues
  • 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

  • Radiation therapy final 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

Chemotherapy, Week 10

  • 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: 1200 mg/m2 IV over 1 hour once per day on day 1
    • Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1

Supportive Medications, Week 10

Chemotherapy, Week 11

  • 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 12

  • 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 13

  • 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: 1200 mg/m2 IV over 1 hour once per day on day 1
    • Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1

Supportive Medications, Week 13

Chemotherapy, Week 14 Off Chemo

Chemotherapy, Week 15 Evaluation


Protocol, Weeks 16-30

Chemotherapy, Week 16

  • 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 100 mg/day) IV over 90 minutes once per day on days 1 through 5

Chemotherapy, Week 17

  • 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 18 Off Chemo

Chemotherapy, Week 19

  • 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 100 mg/day) IV over 90 minutes once per day on days 1 through 5

Chemotherapy, Week 20

  • 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 21 Off Chemo

Chemotherapy, Week 22

  • 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: 1200 mg/m2 IV over 1 hour once per day on day 1
    • Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1

Supportive Medications, Week 22

Chemotherapy, Week 23

  • 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 24

  • 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 25

  • 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 100 mg/day) IV over 90 minutes once per day on days 1 through 5

Chemotherapy, Week 26

  • 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 27 Off Chemo

Chemotherapy, Week 28

  • 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: 1200 mg/m2 IV over 1 hour once per day on day 1
    • Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1

Supportive Medications, Week 28

Chemotherapy, Week 29 Off Chemo

Chemotherapy, Week 30 Evaluation


Protocol, Weeks 31-43

Chemotherapy, Week 31

  • 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 100 mg/day) IV over 90 minutes once per day on days 1 through 5

Chemotherapy, Week 32

  • 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 33

  • 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 34

  • 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: 1200 mg/m2 IV over 1 hour once per day on day 1
    • Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1

Supportive Medications, Week 34

Chemotherapy, Week 35 Off Chemo

Chemotherapy, Week 36 Off Chemo

Chemotherapy, Week 37

  • 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 100 mg/day) IV over 90 minutes once per day on days 1 through 5

Chemotherapy, Week 38

  • 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 39 Off Chemo

Chemotherapy, Week 40

  • 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: 1200 mg/m2 IV over 1 hour once per day on day 1
    • Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1
  • Mesna (Mesnex) by the following age-based criteria:

Chemotherapy, Week 41 Off Chemo

Chemotherapy, Week 42 Off Chemo

Chemotherapy, Week 43 Evaluation

References

  1. COG ARST0531: Hawkins DS, Chi Y, Anderson JR, Tian J, Arndt CAS, Bomgaars L, Donaldson SS, Hayes-Jordan A, Mascarenhas L, McCarville MB, McCune JS, McCowage G, Million L, Morris CD, Parham DM, Rodeberg DA, Rudzinski ER, Shnorhavorian M, Spunt SL, Skapek SX, Teot LA, Wolden S, Yock TI, Meyer WH. Addition of Vincristine and Irinotecan to Vincristine, Dactinomycin, and Cyclophosphamide Does Not Improve Outcome for Intermediate-Risk Rhabdomyosarcoma: A Report From the Children's Oncology Group. J Clin Oncol. 2018 Sep;36(27):2770-2777. Epub 2018 Aug 9. link to original article link to PMC article PubMed NCT01222715

Low Risk

COG ARST1431 Protocol C (VAC/VA)

Study Years of enrollment Evidence
Awaiting publication (COG ARST1431) 2016-2025 Non-randomized arm of phase 3 RCT

Protocol, Cycles 1-4 (Weeks 1 through 12)

Chemotherapy

  • Vincristine (Oncovin) by the following BSA-based criteria:
    • 0.25-0.29 m2 BSA: 0.24 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 1 through 10
    • 0.3-0.34 m2 BSA: 0.34 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 1 through 10
    • 0.35-0.39 m2 BSA: 0.44 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 1 through 10
    • 0.4-0.44 m2 BSA: 0.55 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 1 through 10
    • 0.45-0.49 m2 BSA: 0.65 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 1 through 10
    • 0.5-0.54 m2 BSA: 0.74 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 1 through 10
    • 0.55-0.59 m2 BSA: 0.8 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 1 through 10
    • ≥ 0.6 m2 BSA: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 1 through 10
  • Dactinomycin (Cosmegen) by the following weight-based criteria:
    • 3-4.5 kg: 0.09 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 1, 4, 7, 10
    • 4.6-6 kg: 0.14 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 1, 4, 7, 10
    • 6.1-7.3 kg: 0.21 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 1, 4, 7, 10
    • 7.4-8.6 kg: 0.26 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 1, 4, 7, 10
    • 8.7-9.9 kg: 0.33 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 1, 4, 7, 10
    • 10-11.2 kg: 0.4 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 1, 4, 7, 10
    • 11.3-12.5 kg: 0.5 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 1, 4, 7, 10
    • 12.6-13.9 kg: 0.6 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 1, 4, 7, 10
    • ≥14 kg: 0.05 mg/kg (maximum dose of 2.5 mg) slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 1, 4, 7, 10
  • Cyclophosphamide (Cytoxan) by the following BSA-based criteria:
    • 0.25-0.29 m2 BSA: 220 mg IV over 60 minutes on day 1 of weeks 1, 4, 7, 10
    • 0.3-0.34 m2 BSA: 280 mg IV over 60 minutes on day 1 of weeks 1, 4, 7, 10
    • 0.35-0.39 m2 BSA: 360 mg IV over 60 minutes on day 1 of weeks 1, 4, 7, 10
    • 0.4-0.44 m2 BSA: 440 mg IV over 60 minutes on day 1 of weeks 1, 4, 7, 10
    • 0.45-0.49 m2 BSA: 520 mg IV over 60 minutes on day 1 of weeks 1, 4, 7, 10
    • 0.5-0.54 m2 BSA: 600 mg IV over 60 minutes on day 1 of weeks 1, 4, 7, 10
    • 0.55-0.59 m2 BSA: 660 mg IV over 60 minutes on day 1 of weeks 1, 4, 7, 10
    • ≥ 0.6 m2 BSA: 1200 mg/m2 IV over 60 minutes on day 1 of weeks 1, 4, 7, 10

Supportive Medications


Protocol, Cycles 5-8 (Weeks 13 through 24)

Chemotherapy

  • Vincristine (Oncovin) by the following BSA-based criteria:
    • 0.25-0.29 m2 BSA: 0.24 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 13 through 22
    • 0.3-0.34 m2 BSA: 0.34 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 13 through 22
    • 0.35-0.39 m2 BSA: 0.44 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 13 through 22
    • 0.4-0.44 m2 BSA: 0.55 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 13 through 22
    • 0.45-0.49 m2 BSA: 0.65 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 13 through 22
    • 0.5-0.54 m2 BSA: 0.74 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 13 through 22
    • 0.55-0.59 m2 BSA: 0.8 mg IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 13 through 22
    • ≥ 0.6 m2 BSA: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute (or infusion via minibag as per institutional policy once weekly on day 1 of weeks 13 through 22
  • Dactinomycin (Cosmegen) by the following weight-based criteria:
    • 3-4.5 kg: 0.09 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 13, 16, 19, 22
    • 4.6-6 kg: 0.14 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 13, 16, 19, 22
    • 6.1-7.3 kg: 0.21 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 13, 16, 19, 22
    • 7.4-8.6 kg: 0.26 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 13, 16, 19, 22
    • 8.7-9.9 kg: 0.33 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 13, 16, 19, 22
    • 10-11.2 kg: 0.4 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 13, 16, 19, 22
    • 11.3-12.5 kg: 0.5 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 13, 16, 19, 22
    • 12.6-13.9 kg: 0.6 mg slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 13, 16, 19, 22
    • ≥14 kg: 0.05 mg/kg (maximum dose of 2.5 mg) slow IV push over 1 to 5 minutes or IV infusion over 10 to 15 minutes on day 1 of weeks 13, 16, 19, 22

References

  1. COG ARST1431: NCT02567435

COG ARST0331 protocol

In process

References

  1. COG ARST0331: NCT00075582

High Risk

COG ARST0431 protocol

Study Years of enrollment Evidence
Weigel et al. 2015 (COG ARST0431) 7/17/2006-6/13/2008 Non-randomized

Protocol, Weeks 1-6

Chemotherapy, Week 1 (IRIN-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
  • Irinotecan (Camptosar) 50 mg/m2 (maximum dose of 100 mg/day) IV over 60 minutes once per day on days 1 through 5

Chemotherapy, Week 2 (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

Chemotherapy, Week 3 (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

Chemotherapy, Week 4 (IRIN-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
  • Irinotecan (Camptosar) 50 mg/m2 (maximum dose of 100 mg/day) IV over 60 minutes once per day on days 1 through 5

Chemotherapy, Week 5 (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

Chemotherapy, Week 6 Evaluation


Protocol, Weeks 7-19

Chemotherapy, Week 7 (VDC)

  • 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
  • Doxorubicin (Adriamycin) by the following age-based criteria:
    • Age ≥ 1 year: 37.5 mg/m2 (Total dose per week of 75 mg/m2) IV over 24 hours once per day on days 1 through 2
    • Age < 1 year: 18.75 mg/m2 IV over 24 hours once per day on days 1 through 2
  • Cyclophosphamide (Cytoxan) by the following age-based criteria:
    • Age ≥ 3 years: 1200 mg/m2 IV over 1 hour once per day on day 1
    • Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1

Supportive Medications, Week 7

Chemotherapy, Week 8 (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

Chemotherapy, Week 9 (IE)

  • Ifosfamide (Ifex) by the following age-based criteria:
    • Age ≥ 1 year: 1800 mg/m2 IV over 1 hour once per day on days 1 through 5
    • Age < 1 year: 900 mg/m2 IV over 1 hour once per day on days 1 through 5
  • Etoposide (Vepesid) by the following age-based criteria:
    • Age ≥ 1 year: 100 mg/m2 IV over 30 to 60 minutes once per day on days 1 through 5
    • Age < 1 year: 50 mg/m2 IV over 30 to 60 minutes once per day on days 1 through 5

Supportive Medications, Week 9

  • Mesna (Mesnex) by the following age-based criteria:
    • Age ≥ 3 years: 360 mg/m2 at hour 0, 4, and 8 from the start of each Ifosfamide (Ifex) infusion on days 1 through 5
    • Age < 3 years: 180 mg/m2 at hour 0, 4, and 8 from the start of each Ifosfamide (Ifex) infusion on days 1 through 5

Chemotherapy, Week 10 Off Chemo

Chemotherapy, Week 11 (VDC)

  • 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
  • Doxorubicin (Adriamycin) by the following age-based criteria:
    • Age ≥ 1 year: 37.5 mg/m2 (Total dose per week of 75 mg/m2) IV over 24 hours once per day on days 1 through 2
    • Age < 1 year: 18.75 mg/m2 IV over 24 hours once per day on days 1 through 2
  • Cyclophosphamide (Cytoxan) by the following age-based criteria:
    • Age ≥ 3 years: 1200 mg/m2 IV over 1 hour once per day on day 1
    • Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1

Supportive Medications, Week 11

Chemotherapy, Week 12 (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

Chemotherapy, Week 13 (IE)

  • Ifosfamide (Ifex) by the following age-based criteria:
    • Age ≥ 1 year: 1800 mg/m2 IV over 1 hour once per day on days 1 through 5
    • Age < 1 year: 900 mg/m2 IV over 1 hour once per day on days 1 through 5
  • Etoposide (Vepesid) by the following age-based criteria:
    • Age ≥ 1 year: 100 mg/m2 IV over 30 to 60 minutes once per day on days 1 through 5
    • Age < 1 year: 50 mg/m2 IV over 30 to 60 minutes once per day on days 1 through 5

Supportive Medications, Week 13

  • Mesna (Mesnex) by the following age-based criteria:
    • Age ≥ 3 years: 360 mg/m2 at hour 0, 4, and 8 from the start of each Ifosfamide (Ifex) infusion on days 1 through 5
    • Age < 3 years: 180 mg/m2 at hour 0, 4, and 8 from the start of each Ifosfamide (Ifex) infusion on days 1 through 5

Chemotherapy, Week 14 Off Chemo

Chemotherapy, Week 15 (VDC)

  • 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
  • Doxorubicin (Adriamycin) by the following age-based criteria:
    • Age ≥ 1 year: 37.5 mg/m2 (Total dose per week of 75 mg/m2) IV over 24 hours once per day on days 1 through 2
    • Age < 1 year: 18.75 mg/m2 IV over 24 hours once per day on days 1 through 2
  • Cyclophosphamide (Cytoxan) by the following age-based criteria:
    • Age ≥ 3 years: 1200 mg/m2 IV over 1 hour once per day on day 1
    • Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1

Supportive Medications, Week 15

Chemotherapy, Week 16 (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

Chemotherapy, Week 17 (IE)

  • Ifosfamide (Ifex) by the following age-based criteria:
    • Age ≥ 1 year: 1800 mg/m2 IV over 1 hour once per day on days 1 through 5
    • Age < 1 year: 900 mg/m2 IV over 1 hour once per day on days 1 through 5
  • Etoposide (Vepesid) by the following age-based criteria:
    • Age ≥ 1 year: 100 mg/m2 IV over 30 to 60 minutes once per day on days 1 through 5
    • Age < 1 year: 50 mg/m2 IV over 30 to 60 minutes once per day on days 1 through 5

Supportive Medications, Week 17

  • Mesna (Mesnex) by the following age-based criteria:
    • Age ≥ 3 years: 360 mg/m2 at hour 0, 4, and 8 from the start of each Ifosfamide (Ifex) infusion on days 1 through 5
    • Age < 3 years: 180 mg/m2 at hour 0, 4, and 8 from the start of each Ifosfamide (Ifex) infusion on days 1 through 5

Chemotherapy, Week 18 Off Chemo

Chemotherapy, Week 19 Evaluation


Protocol, Weeks 20-34

Chemotherapy, Week 20 (IRIN-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
  • Irinotecan (Camptosar) 50 mg/m2 (maximum dose of 100 mg/day) IV over 60 minutes once per day on days 1 through 5

Chemotherapy, Week 21 (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

Chemotherapy, Week 22 (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

Chemotherapy, Week 23 (IRIN-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
  • Irinotecan (Camptosar) 50 mg/m2 (maximum dose of 100 mg/day) IV over 60 minutes once per day on days 1 through 5

Chemotherapy, Week 24 (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

Chemotherapy, Week 25 Off Chemo

Chemotherapy, Week 26 (IE)

  • Ifosfamide (Ifex) by the following age-based criteria:
    • Age ≥ 1 year: 1800 mg/m2 IV over 1 hour once per day on days 1 through 5
    • Age < 1 year: 900 mg/m2 IV over 1 hour once per day on days 1 through 5
  • Etoposide (Vepesid) by the following age-based criteria:
    • Age ≥ 1 year: 100 mg/m2 IV over 30 to 60 minutes once per day on days 1 through 5
    • Age < 1 year: 50 mg/m2 IV over 30 to 60 minutes once per day on days 1 through 5

Supportive Medications, Week 26

  • Mesna (Mesnex) by the following age-based criteria:
    • Age ≥ 3 years: 360 mg/m2 at hour 0, 4, and 8 from the start of each Ifosfamide (Ifex) infusion on days 1 through 5
    • Age < 3 years: 180 mg/m2 at hour 0, 4, and 8 from the start of each Ifosfamide (Ifex) infusion on days 1 through 5

Chemotherapy, Week 27 Off Chemo

Chemotherapy, Week 28 (VDC)

  • 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
  • Doxorubicin (Adriamycin) by the following age-based criteria:
    • Age ≥ 1 year: 37.5 mg/m2 (Total dose per week of 75 mg/m2) IV over 24 hours once per day on days 1 through 2
    • Age < 1 year: 18.75 mg/m2 IV over 24 hours once per day on days 1 through 2
  • Cyclophosphamide (Cytoxan) by the following age-based criteria:
    • Age ≥ 3 years: 1200 mg/m2 IV over 1 hour once per day on day 1
    • Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1

Supportive Medications, Week 28

Chemotherapy, Week 29 (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

Chemotherapy, Week 30 (IE)

  • Ifosfamide (Ifex) by the following age-based criteria:
    • Age ≥ 1 year: 1800 mg/m2 IV over 1 hour once per day on days 1 through 5
    • Age < 1 year: 900 mg/m2 IV over 1 hour once per day on days 1 through 5
  • Etoposide (Vepesid) by the following age-based criteria:
    • Age ≥ 1 year: 100 mg/m2 IV over 30 to 60 minutes once per day on days 1 through 5
    • Age < 1 year: 50 mg/m2 IV over 30 to 60 minutes once per day on days 1 through 5

Supportive Medications, Week 30

  • Mesna (Mesnex) by the following age-based criteria:
    • Age ≥ 3 years: 360 mg/m2 at hour 0, 4, and 8 from the start of each Ifosfamide (Ifex) infusion on days 1 through 5
    • Age < 3 years: 180 mg/m2 at hour 0, 4, and 8 from the start of each Ifosfamide (Ifex) infusion on days 1 through 5

Chemotherapy, Week 31 Off Chemo

Chemotherapy, Week 32 (VDC)

  • 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
  • Doxorubicin (Adriamycin) by the following age-based criteria:
    • Age ≥ 1 year: 37.5 mg/m2 (Total dose per week of 75 mg/m2) IV over 24 hours once per day on days 1 through 2
    • Age < 1 year: 18.75 mg/m2 IV over 24 hours once per day on days 1 through 2
  • Cyclophosphamide (Cytoxan) by the following age-based criteria:
    • Age ≥ 3 years: 1200 mg/m2 IV over 1 hour once per day on day 1
    • Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1

Supportive Medications, Week 32

Chemotherapy, 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

Chemotherapy, Week 34 Evaluation


Protocol, Weeks 35-54

Chemotherapy, 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: 1200 mg/m2 IV over 1 hour once per day on day 1
    • Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1

Supportive Medications, Week 35

Chemotherapy, Week 36 Off Chemo

Chemotherapy, Week 37 Off Chemo

Chemotherapy, 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: 1200 mg/m2 IV over 1 hour once per day on day 1
    • Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1

Supportive Medications, Week 38

Chemotherapy, Week 39 Off Chemo

Chemotherapy, Week 40 Off Chemo

Chemotherapy, 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: 1200 mg/m2 IV over 1 hour once per day on day 1
    • Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1

Supportive Medications, Week 41

Chemotherapy, Week 42 (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

Chemotherapy, Week 43 (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

Chemotherapy, Week 44 (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: 1200 mg/m2 IV over 1 hour once per day on day 1
    • Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1

Supportive Medications, Week 44

Chemotherapy, Week 45 Off Chemo

Chemotherapy, Week 46 Off Chemo

Chemotherapy, Week 47 (IRIN-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
  • Irinotecan (Camptosar) 50 mg/m2 (maximum dose of 100 mg/day) IV over 60 minutes once per day on days 1 through 5

Chemotherapy, Week 48 (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

Chemotherapy, Week 49 Off Chemo

Chemotherapy, Week 50 (IRIN-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
  • Irinotecan (Camptosar) 50 mg/m2 (maximum dose of 100 mg/day) IV over 60 minutes once per day on days 1 through 5

Chemotherapy, Week 51 (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

Chemotherapy, Week 52 Off Chemo

Chemotherapy, Week 53 Off Chemo

Chemotherapy, Week 54 Evaluation

References

  1. COG ARST0431: Weigel BJ, Lyden E, Anderson JR, Meyer WH, Parham DM, Rodeberg DA, Michalski JM, Hawkins DS, Arndt CAS. Intensive Multiagent Therapy, Including Dose-Compressed Cycles of Ifosfamide/Etoposide and Vincristine/Doxorubicin/Cyclophosphamide, Irinotecan, and Radiation, in Patients with High-Risk Rhabdomyosarcoma: A Report from the Children's Oncology Group. Journal of Clinical Oncology. 2016 Oct;34(2):117-122. Epub 2015 Oct 26. link to original article link to PMC article PubMed NCT00354744
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