Difference between revisions of "Rhabdomyosarcoma, pediatric"
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**0.55-0.59 m<sup>2</sup> BSA: 28 mg IV over 90 minutes once daily on days 1 through 5 of weeks 4 and 10 | **0.55-0.59 m<sup>2</sup> BSA: 28 mg IV over 90 minutes once daily on days 1 through 5 of weeks 4 and 10 | ||
**≥ 0.6 m<sup>2</sup> BSA: 50 mg/m<sup>2</sup> IV over 90 minutes once daily on days 1 through 5 of weeks 4 and 10 | **≥ 0.6 m<sup>2</sup> BSA: 50 mg/m<sup>2</sup> IV over 90 minutes once daily on days 1 through 5 of weeks 4 and 10 | ||
| − | ====Supportive | + | ====Supportive therapy==== |
*[[Mesna (Mesnex)]] by the following BSA-based criteria: | *[[Mesna (Mesnex)]] by the following BSA-based criteria: | ||
**0.25-0.29 m<sup>2</sup> BSA: 176 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 | **0.25-0.29 m<sup>2</sup> BSA: 176 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 | ||
| Line 123: | Line 123: | ||
**0.55-0.59 m<sup>2</sup> BSA: 28 mg IV over 90 minutes once daily on days 1 through 5 of weeks 16, 19, 25 | **0.55-0.59 m<sup>2</sup> BSA: 28 mg IV over 90 minutes once daily on days 1 through 5 of weeks 16, 19, 25 | ||
**≥ 0.6 m<sup>2</sup> BSA: 50 mg/m<sup>2</sup> IV over 90 minutes once daily on days 1 through 5 of weeks 16, 19, 25 | **≥ 0.6 m<sup>2</sup> BSA: 50 mg/m<sup>2</sup> IV over 90 minutes once daily on days 1 through 5 of weeks 16, 19, 25 | ||
| − | ====Supportive | + | ====Supportive therapy==== |
*[[Mesna (Mesnex)]] by the following BSA-based criteria: | *[[Mesna (Mesnex)]] by the following BSA-based criteria: | ||
**0.25-0.29 m<sup>2</sup> BSA: 176 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 | **0.25-0.29 m<sup>2</sup> BSA: 176 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 | ||
| Line 176: | Line 176: | ||
**0.55-0.59 m<sup>2</sup> BSA: 28 mg IV over 90 minutes once daily on days 1 through 5 of weeks 31, 37 | **0.55-0.59 m<sup>2</sup> BSA: 28 mg IV over 90 minutes once daily on days 1 through 5 of weeks 31, 37 | ||
**≥ 0.6 m<sup>2</sup> BSA: 50 mg/m<sup>2</sup> IV over 90 minutes once daily on days 1 through 5 of weeks 31, 37 | **≥ 0.6 m<sup>2</sup> BSA: 50 mg/m<sup>2</sup> IV over 90 minutes once daily on days 1 through 5 of weeks 31, 37 | ||
| − | ====Supportive | + | ====Supportive therapy==== |
*[[Mesna (Mesnex)]] by the following BSA-based criteria: | *[[Mesna (Mesnex)]] by the following BSA-based criteria: | ||
**0.25-0.29 m<sup>2</sup> BSA: 176 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 | **0.25-0.29 m<sup>2</sup> BSA: 176 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 | ||
| Line 267: | Line 267: | ||
**0.55-0.59 m<sup>2</sup> BSA: 28 mg IV over 90 minutes once daily on days 1 through 5 of weeks 4 and 10 | **0.55-0.59 m<sup>2</sup> BSA: 28 mg IV over 90 minutes once daily on days 1 through 5 of weeks 4 and 10 | ||
**≥ 0.6 m<sup>2</sup> BSA: 50 mg/m<sup>2</sup> IV over 90 minutes once daily on days 1 through 5 of weeks 4 and 10 | **≥ 0.6 m<sup>2</sup> BSA: 50 mg/m<sup>2</sup> IV over 90 minutes once daily on days 1 through 5 of weeks 4 and 10 | ||
| − | ====Supportive | + | ====Supportive therapy==== |
*[[Mesna (Mesnex)]] by the following BSA-based criteria: | *[[Mesna (Mesnex)]] by the following BSA-based criteria: | ||
[[Mesna (Mesnex)]] can also be given PO at twice the IV dose | [[Mesna (Mesnex)]] can also be given PO at twice the IV dose | ||
| Line 324: | Line 324: | ||
**0.55-0.59 m<sup>2</sup> BSA: 28 mg IV over 90 minutes once daily on days 1 through 5 of weeks 16, 19, 25 | **0.55-0.59 m<sup>2</sup> BSA: 28 mg IV over 90 minutes once daily on days 1 through 5 of weeks 16, 19, 25 | ||
**≥ 0.6 m<sup>2</sup> BSA: 50 mg/m<sup>2</sup> IV over 90 minutes once daily on days 1 through 5 of weeks 16, 19, 25 | **≥ 0.6 m<sup>2</sup> BSA: 50 mg/m<sup>2</sup> IV over 90 minutes once daily on days 1 through 5 of weeks 16, 19, 25 | ||
| − | ====Supportive | + | ====Supportive therapy==== |
*[[Mesna (Mesnex)]] by the following BSA-based criteria: | *[[Mesna (Mesnex)]] by the following BSA-based criteria: | ||
[[Mesna (Mesnex)]] can also be given PO at twice the IV dose | [[Mesna (Mesnex)]] can also be given PO at twice the IV dose | ||
| Line 380: | Line 380: | ||
**0.55-0.59 m<sup>2</sup> BSA: 28 mg IV over 90 minutes once daily on days 1 through 5 of weeks 31, 37 | **0.55-0.59 m<sup>2</sup> BSA: 28 mg IV over 90 minutes once daily on days 1 through 5 of weeks 31, 37 | ||
**≥ 0.6 m<sup>2</sup> BSA: 50 mg/m<sup>2</sup> IV over 90 minutes once daily on days 1 through 5 of weeks 31, 37 | **≥ 0.6 m<sup>2</sup> BSA: 50 mg/m<sup>2</sup> IV over 90 minutes once daily on days 1 through 5 of weeks 31, 37 | ||
| − | ====Supportive | + | ====Supportive therapy==== |
*[[Mesna (Mesnex)]] by the following BSA-based criteria: | *[[Mesna (Mesnex)]] by the following BSA-based criteria: | ||
[[Mesna (Mesnex)]] can also be given PO at twice the IV dose | [[Mesna (Mesnex)]] can also be given PO at twice the IV dose | ||
| Line 441: | Line 441: | ||
**Age ≥ 3 years: 1200 mg/m<sup>2</sup> IV over 1 hour once per day on day 1 | **Age ≥ 3 years: 1200 mg/m<sup>2</sup> 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 | **Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1 | ||
| − | ====Supportive | + | ====Supportive therapy, Week 1==== |
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
**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 | ||
| Line 467: | Line 467: | ||
**Age ≥ 3 years: 1200 mg/m<sup>2</sup> IV over 1 hour once per day on day 1 | **Age ≥ 3 years: 1200 mg/m<sup>2</sup> 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 | **Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1 | ||
| − | ====Supportive | + | ====Supportive therapy, Week 4==== |
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
**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 | ||
| Line 492: | Line 492: | ||
**Age ≥ 3 years: 1200 mg/m<sup>2</sup> IV over 1 hour once per day on day 1 | **Age ≥ 3 years: 1200 mg/m<sup>2</sup> 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 | **Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1 | ||
| − | ====Supportive | + | ====Supportive therapy, Week 7==== |
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
**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 | ||
| Line 516: | Line 516: | ||
**Age ≥ 3 years: 1200 mg/m<sup>2</sup> IV over 1 hour once per day on day 1 | **Age ≥ 3 years: 1200 mg/m<sup>2</sup> 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 | **Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1 | ||
| − | ====Supportive | + | ====Supportive therapy, Week 10==== |
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
**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 | ||
| Line 541: | Line 541: | ||
**Age ≥ 3 years: 1200 mg/m<sup>2</sup> IV over 1 hour once per day on day 1 | **Age ≥ 3 years: 1200 mg/m<sup>2</sup> 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 | **Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1 | ||
| − | ====Supportive | + | ====Supportive therapy, Week 13==== |
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
**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 | ||
| Line 563: | Line 563: | ||
**Age ≥ 3 years: 1200 mg/m<sup>2</sup> IV over 1 hour once per day on day 1 | **Age ≥ 3 years: 1200 mg/m<sup>2</sup> 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 | **Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1 | ||
| − | ====Supportive | + | ====Supportive therapy, Week 16==== |
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
**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 | ||
| Line 580: | Line 580: | ||
**Age ≥ 3 years: 1200 mg/m<sup>2</sup> IV over 1 hour once per day on day 1 | **Age ≥ 3 years: 1200 mg/m<sup>2</sup> 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 | **Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1 | ||
| − | ====Supportive | + | ====Supportive therapy, Week 19==== |
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
**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 | ||
| Line 605: | Line 605: | ||
**Age ≥ 3 years: 1200 mg/m<sup>2</sup> IV over 1 hour once per day on day 1 | **Age ≥ 3 years: 1200 mg/m<sup>2</sup> 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 | **Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1 | ||
| − | ====Supportive | + | ====Supportive therapy, Week 22==== |
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
**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 | ||
| Line 630: | Line 630: | ||
**Age ≥ 3 years: 1200 mg/m<sup>2</sup> IV over 1 hour once per day on day 1 | **Age ≥ 3 years: 1200 mg/m<sup>2</sup> 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 | **Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1 | ||
| − | ====Supportive | + | ====Supportive therapy, Week 25==== |
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
**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 | ||
| Line 647: | Line 647: | ||
**Age ≥ 3 years: 1200 mg/m<sup>2</sup> IV over 1 hour once per day on day 1 | **Age ≥ 3 years: 1200 mg/m<sup>2</sup> 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 | **Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1 | ||
| − | ====Supportive | + | ====Supportive therapy, Week 28==== |
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
**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 | ||
| Line 668: | Line 668: | ||
**Age ≥ 3 years: 1200 mg/m<sup>2</sup> IV over 1 hour once per day on day 1 | **Age ≥ 3 years: 1200 mg/m<sup>2</sup> 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 | **Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1 | ||
| − | ====Supportive | + | ====Supportive therapy, Week 31==== |
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
**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 | ||
| Line 693: | Line 693: | ||
**Age ≥ 3 years: 1200 mg/m<sup>2</sup> IV over 1 hour once per day on day 1 | **Age ≥ 3 years: 1200 mg/m<sup>2</sup> 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 | **Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1 | ||
| − | ====Supportive | + | ====Supportive therapy, Week 34==== |
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
**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 | ||
| Line 718: | Line 718: | ||
**Age ≥ 3 years: 1200 mg/m<sup>2</sup> IV over 1 hour once per day on day 1 | **Age ≥ 3 years: 1200 mg/m<sup>2</sup> 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 | **Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1 | ||
| − | ====Supportive | + | ====Supportive therapy, Week 37==== |
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
**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 | ||
| Line 735: | Line 735: | ||
**Age ≥ 3 years: 1200 mg/m<sup>2</sup> IV over 1 hour once per day on day 1 | **Age ≥ 3 years: 1200 mg/m<sup>2</sup> 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 | **Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1 | ||
| − | ====Supportive | + | ====Supportive therapy, Week 40==== |
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
**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 | ||
| Line 775: | Line 775: | ||
**Age ≥ 3 years: 1200 mg/m<sup>2</sup> IV over 1 hour once per day on day 1 | **Age ≥ 3 years: 1200 mg/m<sup>2</sup> 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 | **Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1 | ||
| − | ====Supportive | + | ====Supportive therapy, Week 1==== |
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
**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 | ||
| Line 837: | Line 837: | ||
**Age ≥ 3 years: 1200 mg/m<sup>2</sup> IV over 1 hour once per day on day 1 | **Age ≥ 3 years: 1200 mg/m<sup>2</sup> 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 | **Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1 | ||
| − | ====Supportive | + | ====Supportive therapy, Week 10==== |
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
**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 | ||
| Line 862: | Line 862: | ||
**Age ≥ 3 years: 1200 mg/m<sup>2</sup> IV over 1 hour once per day on day 1 | **Age ≥ 3 years: 1200 mg/m<sup>2</sup> 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 | **Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1 | ||
| − | ====Supportive | + | ====Supportive therapy, Week 13==== |
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
**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 | ||
| Line 909: | Line 909: | ||
**Age ≥ 3 years: 1200 mg/m<sup>2</sup> IV over 1 hour once per day on day 1 | **Age ≥ 3 years: 1200 mg/m<sup>2</sup> 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 | **Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1 | ||
| − | ====Supportive | + | ====Supportive therapy, Week 22==== |
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
**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 | ||
| Line 947: | Line 947: | ||
**Age ≥ 3 years: 1200 mg/m<sup>2</sup> IV over 1 hour once per day on day 1 | **Age ≥ 3 years: 1200 mg/m<sup>2</sup> 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 | **Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1 | ||
| − | ====Supportive | + | ====Supportive therapy, Week 28==== |
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
**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 | ||
| Line 985: | Line 985: | ||
**Age ≥ 3 years: 1200 mg/m<sup>2</sup> IV over 1 hour once per day on day 1 | **Age ≥ 3 years: 1200 mg/m<sup>2</sup> 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 | **Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1 | ||
| − | ====Supportive | + | ====Supportive therapy, Week 34==== |
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
**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 | ||
| Line 1,069: | Line 1,069: | ||
**0.55-0.59 m<sup>2</sup> BSA: 660 mg IV over 60 minutes on day 1 of weeks 1, 4, 7, 10 | **0.55-0.59 m<sup>2</sup> BSA: 660 mg IV over 60 minutes on day 1 of weeks 1, 4, 7, 10 | ||
**≥ 0.6 m<sup>2</sup> BSA: 1200 mg/m<sup>2</sup> IV over 60 minutes on day 1 of weeks 1, 4, 7, 10 | **≥ 0.6 m<sup>2</sup> BSA: 1200 mg/m<sup>2</sup> IV over 60 minutes on day 1 of weeks 1, 4, 7, 10 | ||
| − | ====Supportive | + | ====Supportive therapy==== |
*[[Mesna (Mesnex)]] by the following BSA-based criteria: | *[[Mesna (Mesnex)]] by the following BSA-based criteria: | ||
**0.25-0.29 m<sup>2</sup> BSA: 176 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 | **0.25-0.29 m<sup>2</sup> BSA: 176 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 | ||
| Line 1,173: | Line 1,173: | ||
**Age ≥ 3 years: 1200 mg/m<sup>2</sup> IV over 1 hour once per day on day 1 | **Age ≥ 3 years: 1200 mg/m<sup>2</sup> 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 | **Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1 | ||
| − | ====Supportive | + | ====Supportive therapy, Week 7==== |
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
**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 | ||
| Line 1,189: | Line 1,189: | ||
**Age ≥ 1 year: 100 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on days 1 through 5 | **Age ≥ 1 year: 100 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on days 1 through 5 | ||
**Age < 1 year: 50 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on days 1 through 5 | **Age < 1 year: 50 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on days 1 through 5 | ||
| − | ====Supportive | + | ====Supportive therapy, Week 9==== |
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
**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 | ||
| Line 1,205: | Line 1,205: | ||
**Age ≥ 3 years: 1200 mg/m<sup>2</sup> IV over 1 hour once per day on day 1 | **Age ≥ 3 years: 1200 mg/m<sup>2</sup> 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 | **Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1 | ||
| − | ====Supportive | + | ====Supportive therapy, Week 11==== |
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
**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 | ||
| Line 1,221: | Line 1,221: | ||
**Age ≥ 1 year: 100 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on days 1 through 5 | **Age ≥ 1 year: 100 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on days 1 through 5 | ||
**Age < 1 year: 50 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on days 1 through 5 | **Age < 1 year: 50 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on days 1 through 5 | ||
| − | ====Supportive | + | ====Supportive therapy, Week 13==== |
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
**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 | ||
| Line 1,237: | Line 1,237: | ||
**Age ≥ 3 years: 1200 mg/m<sup>2</sup> IV over 1 hour once per day on day 1 | **Age ≥ 3 years: 1200 mg/m<sup>2</sup> 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 | **Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1 | ||
| − | ====Supportive | + | ====Supportive therapy, Week 15==== |
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
**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 | ||
| Line 1,253: | Line 1,253: | ||
**Age ≥ 1 year: 100 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on days 1 through 5 | **Age ≥ 1 year: 100 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on days 1 through 5 | ||
**Age < 1 year: 50 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on days 1 through 5 | **Age < 1 year: 50 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on days 1 through 5 | ||
| − | ====Supportive | + | ====Supportive therapy, Week 17==== |
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
**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 | ||
| Line 1,300: | Line 1,300: | ||
**Age ≥ 1 year: 100 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on days 1 through 5 | **Age ≥ 1 year: 100 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on days 1 through 5 | ||
**Age < 1 year: 50 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on days 1 through 5 | **Age < 1 year: 50 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on days 1 through 5 | ||
| − | ====Supportive | + | ====Supportive therapy, Week 26==== |
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
**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 | ||
| Line 1,316: | Line 1,316: | ||
**Age ≥ 3 years: 1200 mg/m<sup>2</sup> IV over 1 hour once per day on day 1 | **Age ≥ 3 years: 1200 mg/m<sup>2</sup> 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 | **Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1 | ||
| − | ====Supportive | + | ====Supportive therapy, Week 28==== |
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
**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 | ||
| Line 1,332: | Line 1,332: | ||
**Age ≥ 1 year: 100 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on days 1 through 5 | **Age ≥ 1 year: 100 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on days 1 through 5 | ||
**Age < 1 year: 50 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on days 1 through 5 | **Age < 1 year: 50 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on days 1 through 5 | ||
| − | ====Supportive | + | ====Supportive therapy, Week 30==== |
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
**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 | ||
| Line 1,348: | Line 1,348: | ||
**Age ≥ 3 years: 1200 mg/m<sup>2</sup> IV over 1 hour once per day on day 1 | **Age ≥ 3 years: 1200 mg/m<sup>2</sup> 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 | **Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1 | ||
| − | ====Supportive | + | ====Supportive therapy, Week 32==== |
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
**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 | ||
| Line 1,373: | Line 1,373: | ||
**Age ≥ 3 years: 1200 mg/m<sup>2</sup> IV over 1 hour once per day on day 1 | **Age ≥ 3 years: 1200 mg/m<sup>2</sup> 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 | **Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1 | ||
| − | ====Supportive | + | ====Supportive therapy, Week 35==== |
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
**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 | ||
| Line 1,390: | Line 1,390: | ||
**Age ≥ 3 years: 1200 mg/m<sup>2</sup> IV over 1 hour once per day on day 1 | **Age ≥ 3 years: 1200 mg/m<sup>2</sup> 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 | **Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1 | ||
| − | ====Supportive | + | ====Supportive therapy, Week 38==== |
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
**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 | ||
| Line 1,407: | Line 1,407: | ||
**Age ≥ 3 years: 1200 mg/m<sup>2</sup> IV over 1 hour once per day on day 1 | **Age ≥ 3 years: 1200 mg/m<sup>2</sup> 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 | **Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1 | ||
| − | ====Supportive | + | ====Supportive therapy, Week 41==== |
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
**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 | ||
| Line 1,432: | Line 1,432: | ||
**Age ≥ 3 years: 1200 mg/m<sup>2</sup> IV over 1 hour once per day on day 1 | **Age ≥ 3 years: 1200 mg/m<sup>2</sup> 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 | **Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1 | ||
| − | ====Supportive | + | ====Supportive therapy, Week 44==== |
*[[Mesna (Mesnex)]] by the following age-based criteria: | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
**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 | ||
Revision as of 18:45, 24 March 2023
Section editor transclusions
This page contains studies that were specific to pediatric populations. For the more general RMS page, follow this link.
Are you looking for a regimen, but can't find it here? It is possible that we've moved it to the historical regimens page. If you still can't find it, please let us know so we can add it!
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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 therapy
- Mesna (Mesnex) by the following BSA-based criteria:
- 0.25-0.29 m2 BSA: 176 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
- 0.3-0.34 m2 BSA: 224 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
- 0.35-0.39 m2 BSA: 288 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
- 0.4-0.44 m2 BSA: 352 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
- 0.45-0.49 m2 BSA: 416 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
- 0.5-0.54 m2 BSA: 480 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 m2 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 m2 BSA: 960 mg/m2 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
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 therapy
- Mesna (Mesnex) by the following BSA-based criteria:
- 0.25-0.29 m2 BSA: 176 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
- 0.3-0.34 m2 BSA: 224 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
- 0.35-0.39 m2 BSA: 288 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
- 0.4-0.44 m2 BSA: 352 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
- 0.45-0.49 m2 BSA: 416 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
- 0.5-0.54 m2 BSA: 480 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 m2 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 m2 BSA: 960 mg/m2 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
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 therapy
- Mesna (Mesnex) by the following BSA-based criteria:
- 0.25-0.29 m2 BSA: 176 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
- 0.3-0.34 m2 BSA: 224 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
- 0.35-0.39 m2 BSA: 288 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
- 0.4-0.44 m2 BSA: 352 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
- 0.45-0.49 m2 BSA: 416 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
- 0.5-0.54 m2 BSA: 480 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 m2 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 m2 BSA: 960 mg/m2 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
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
- 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 therapy
- Mesna (Mesnex) by the following BSA-based criteria:
Mesna (Mesnex) can also be given PO at twice the IV dose
- 0.25-0.29 m2 BSA: 176 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
- 0.3-0.34 m2 BSA: 224 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
- 0.35-0.39 m2 BSA: 288 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
- 0.4-0.44 m2 BSA: 352 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
- 0.45-0.49 m2 BSA: 416 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
- 0.5-0.54 m2 BSA: 480 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 m2 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 m2 BSA: 960 mg/m2 IV over 15 to 30 minutes immediately before Cyclophosphamide (Cytoxan) infusion, and again 4 and 8 hours after the start of Cyclophosphamide (Cytoxan) infusion
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 therapy
- Mesna (Mesnex) by the following BSA-based criteria:
Mesna (Mesnex) can also be given PO at twice the IV dose
- 0.25-0.29 m2 BSA: 176 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
- 0.3-0.34 m2 BSA: 224 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
- 0.35-0.39 m2 BSA: 288 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
- 0.4-0.44 m2 BSA: 352 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
- 0.45-0.49 m2 BSA: 416 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
- 0.5-0.54 m2 BSA: 480 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 m2 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 m2 BSA: 960 mg/m2 IV over 15 to 30 minutes immediately before Cyclophosphamide (Cytoxan) infusion, and again 4 and 8 hours after the start of Cyclophosphamide (Cytoxan) infusion
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 therapy
- Mesna (Mesnex) by the following BSA-based criteria:
Mesna (Mesnex) can also be given PO at twice the IV dose
- 0.25-0.29 m2 BSA: 176 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
- 0.3-0.34 m2 BSA: 224 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
- 0.35-0.39 m2 BSA: 288 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
- 0.4-0.44 m2 BSA: 352 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
- 0.45-0.49 m2 BSA: 416 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
- 0.5-0.54 m2 BSA: 480 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 m2 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 m2 BSA: 960 mg/m2 IV over 15 to 30 minutes immediately before Cyclophosphamide (Cytoxan) infusion, and again 4 and 8 hours after the start of Cyclophosphamide (Cytoxan) infusion
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
- 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
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 therapy, Week 1
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 240 mg/m2 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 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 therapy, Week 4
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 240 mg/m2 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
- 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 therapy, Week 7
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 240 mg/m2 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
- 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 therapy, Week 10
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 240 mg/m2 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 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 therapy, Week 13
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 240 mg/m2 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 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 therapy, Week 16
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 240 mg/m2 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 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 therapy, Week 19
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 240 mg/m2 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 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 therapy, Week 22
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 240 mg/m2 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 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 therapy, Week 25
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 240 mg/m2 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 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 therapy, Week 28
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 240 mg/m2 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 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 therapy, Week 31
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 240 mg/m2 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 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 therapy, Week 34
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 240 mg/m2 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
- 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 therapy, Week 37
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 240 mg/m2 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 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 therapy, Week 40
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 240 mg/m2 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 42 Off Chemo
Chemotherapy, Week 43 Evaluation
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. 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 therapy, Week 1
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 240 mg/m2 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 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
- Administer Vincristine (Oncovin) before Irinotecan (Camptosar)
- 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
- Administer Vincristine (Oncovin) before Irinotecan (Camptosar)
- 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 therapy, Week 10
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 240 mg/m2 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 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 therapy, Week 13
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 240 mg/m2 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 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
- Administer Vincristine (Oncovin) before Irinotecan (Camptosar)
- 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
- Administer Vincristine (Oncovin) before Irinotecan (Camptosar)
- 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 therapy, Week 22
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 240 mg/m2 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 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
- Administer Vincristine (Oncovin) before Irinotecan (Camptosar)
- 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 therapy, Week 28
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 240 mg/m2 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 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
- Administer Vincristine (Oncovin) before Irinotecan (Camptosar)
- 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 therapy, Week 34
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 240 mg/m2 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 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
- Administer Vincristine (Oncovin) before Irinotecan (Camptosar)
- 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:
- Age ≥ 3 years: 240 mg/m2 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 42 Off Chemo
Chemotherapy, Week 43 Evaluation
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. 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 therapy
- Mesna (Mesnex) by the following BSA-based criteria:
- 0.25-0.29 m2 BSA: 176 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
- 0.3-0.34 m2 BSA: 224 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
- 0.35-0.39 m2 BSA: 288 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
- 0.4-0.44 m2 BSA: 352 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
- 0.45-0.49 m2 BSA: 416 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
- 0.5-0.54 m2 BSA: 480 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 m2 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 m2 BSA: 960 mg/m2 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
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
- COG ARST1431: NCT02567435
COG ARST0331 protocol
In process
References
- 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
- Administer Vincristine (Oncovin) before Irinotecan (Camptosar)
- 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
- Administer Vincristine (Oncovin) before Irinotecan (Camptosar)
- 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 therapy, Week 7
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 240 mg/m2 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 (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 therapy, 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 therapy, Week 11
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 240 mg/m2 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 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 therapy, 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 therapy, Week 15
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 240 mg/m2 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 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 therapy, 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
- Administer Vincristine (Oncovin) before Irinotecan (Camptosar)
- 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
- Administer Vincristine (Oncovin) before Irinotecan (Camptosar)
- 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 therapy, 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 therapy, Week 28
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 240 mg/m2 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 (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 therapy, 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 therapy, Week 32
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 240 mg/m2 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 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 therapy, Week 35
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 240 mg/m2 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 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 therapy, Week 38
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 240 mg/m2 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 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 therapy, Week 41
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 240 mg/m2 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 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 therapy, Week 44
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 240 mg/m2 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 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
- Administer Vincristine (Oncovin) before Irinotecan (Camptosar)
- 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
- Administer Vincristine (Oncovin) before Irinotecan (Camptosar)
- 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
- 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. J Clin Oncol. 2016 Oct;34(2):117-122. Epub 2015 Oct 26. link to original article link to PMC article PubMed NCT00354744