Rhabdomyosarcoma, pediatric - historical

The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. As a general rule, this includes the inferior arm(s) of a randomized study, unless said regimens continue to be recommended by trustworthy sources such as the NCCN Guidelines. Is there a regimen missing from this list? See the pediatric rhabdomyosarcoma page for current regimens.

1 regimens on this page 1 variants on this page

Unstratified, all lines of therapy

Dactinomycin monotherapy

Regimen

Study	Evidence
Pinkel 1959	Pilot

Chemotherapy

• Dactinomycin (Cosmegen)

References

1. Pinkel D. Actinomycin D in childhood cancer; a preliminary report. Pediatrics. 1959 Feb;23(2):342-7. link to original article PubMed

High Risk, all lines of therapy

COG D9802 VCPT Alternating with VAC Arm

Study	Years of enrollment	Evidence
Pappo et al. 2007 (COG D9802)	9/1999-11/2000	Phase 2

Protocol, Irinotecan Window

Chemotherapy, Week 0 (VCPT)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
• Irinotecan (Camptosar) 50 mg/m² (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 through 5
  • Irinotecan (Camptosar) to be given after Vincristine (Oncovin)

Chemotherapy, Week 1 (VCPT)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
• Irinotecan (Camptosar) 50 mg/m² (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 through 5
  • Irinotecan (Camptosar) to be given after Vincristine (Oncovin)

Chemotherapy, Week 2 Off Chemo

Chemotherapy, Week 3 (VCPT)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
• Irinotecan (Camptosar) 50 mg/m² (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 through 5
  • Irinotecan (Camptosar) to be given after Vincristine (Oncovin)

Chemotherapy, Week 4 (VCPT)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
• Irinotecan (Camptosar) 50 mg/m² (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 through 5
  • Irinotecan (Camptosar) to be given after Vincristine (Oncovin)

Chemotherapy, Week 5 Evaluation

Induction

Chemotherapy, Week 6 (VAC)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
• Dactinomycin (Cosmegen) by the following age-based criteria:
  • Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
  • Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
• Cyclophosphamide (Cytoxan) by the following age-based criteria:
  • Age ≥ 3 years: 2.2 g/m² IV infusion over 30 to 60 minutes once per day on day 1
  • Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
  • Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1

Supportive Medications, Week 6

• Mesna (Mesnex) by the following age-based criteria:
  • Age ≥ 3 years: 440 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age ≥ 1 year: 14.6 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age < 1 year: 7.2 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1

Chemotherapy, Week 7 (Vincristine)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 8 (Vincristine)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 9 (VCPT)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
• Irinotecan (Camptosar) 50 mg/m² (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 through 5
  • Irinotecan (Camptosar) to be given after Vincristine (Oncovin)

Chemotherapy, Week 10 (VCPT)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
• Irinotecan (Camptosar) 50 mg/m² (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 through 5
  • Irinotecan (Camptosar) to be given after Vincristine (Oncovin)

Chemotherapy, Week 11 (Vincristine)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 12 (VAC)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
• Dactinomycin (Cosmegen) by the following age-based criteria:
  • Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
  • Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
• Cyclophosphamide (Cytoxan) by the following age-based criteria:
  • Age ≥ 3 years: 2.2 g/m² IV infusion over 30 to 60 minutes once per day on day 1
  • Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
  • Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1

Supportive Medications, Week 12

• Mesna (Mesnex) by the following age-based criteria:
  • Age ≥ 3 years: 440 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age ≥ 1 year: 14.6 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age < 1 year: 7.2 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1

Chemotherapy, Week 13 (Vincristine)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 14 Evaluation

Chemotherapy, Week 15 (Vincristine)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 16 (VC)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
• Cyclophosphamide (Cytoxan) by the following age-based criteria:
  • Age ≥ 3 years: 2.2 g/m² IV infusion over 30 to 60 minutes once per day on day 1
  • Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
  • Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1

Supportive Medications, Week 16

• Mesna (Mesnex) by the following age-based criteria:
  • Age ≥ 3 years: 440 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age ≥ 1 year: 14.6 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age < 1 year: 7.2 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1

Chemotherapy, Week 17 (Vincristine)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 18 (Vincristine)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 19 (VC)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
• Cyclophosphamide (Cytoxan) by the following age-based criteria:
  • Age ≥ 3 years: 2.2 g/m² IV infusion over 30 to 60 minutes once per day on day 1
  • Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
  • Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1

Supportive Medications, Week 19

• Mesna (Mesnex) by the following age-based criteria:
  • Age ≥ 3 years: 440 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age ≥ 1 year: 14.6 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age < 1 year: 7.2 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1

Chemotherapy, Week 20 through 22 Off Chemo

Chemotherapy, Week 23 (VAC)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
• Dactinomycin (Cosmegen) by the following age-based criteria:
  • Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
  • Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
• Cyclophosphamide (Cytoxan) by the following age-based criteria:
  • Age ≥ 3 years: 2.2 g/m² IV infusion over 30 to 60 minutes once per day on day 1
  • Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
  • Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1

Supportive Medications, Week 23

• Mesna (Mesnex) by the following age-based criteria:
  • Age ≥ 3 years: 440 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age ≥ 1 year: 14.6 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age < 1 year: 7.2 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1

Chemotherapy, Week 24 (Vincristine)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 25 (Eval/Vincristine)

• Evaluation Week
• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Continuation

Chemotherapy, Week 26 (VCPT)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
• Irinotecan (Camptosar) 50 mg/m² (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 through 5
  • Irinotecan (Camptosar) to be given after Vincristine (Oncovin)

Chemotherapy, Week 27 (VCPT)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
• Irinotecan (Camptosar) 50 mg/m² (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 through 5
  • Irinotecan (Camptosar) to be given after Vincristine (Oncovin)

Chemotherapy, Week 28 Off Chemo

Chemotherapy, Week 29 (VAC)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
• Dactinomycin (Cosmegen) by the following age-based criteria:
  • Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
  • Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
• Cyclophosphamide (Cytoxan) by the following age-based criteria:
  • Age ≥ 3 years: 2.2 g/m² IV infusion over 30 to 60 minutes once per day on day 1
  • Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
  • Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1

Supportive Medications, Week 29

• Mesna (Mesnex) by the following age-based criteria:
  • Age ≥ 3 years: 440 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age ≥ 1 year: 14.6 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age < 1 year: 7.2 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1

Chemotherapy, Week 30 through 31 Off Chemo

Chemotherapy, Week 32 (VCPT)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
• Irinotecan (Camptosar) 50 mg/m² (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 through 5
  • Irinotecan (Camptosar) to be given after Vincristine (Oncovin)

Chemotherapy, Week 33 (VCPT)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
• Irinotecan (Camptosar) 50 mg/m² (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 through 5
  • Irinotecan (Camptosar) to be given after Vincristine (Oncovin)

Chemotherapy, Week 34 (Vincristine)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

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: 2.2 g/m² IV infusion over 30 to 60 minutes once per day on day 1
  • Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
  • Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1

Supportive Medications, Week 35

• Mesna (Mesnex) by the following age-based criteria:
  • Age ≥ 3 years: 440 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age ≥ 1 year: 14.6 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age < 1 year: 7.2 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1

Chemotherapy, Week 36 through 37 Off Chemo

Chemotherapy, Week 38 (VCPT)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
• Irinotecan (Camptosar) 50 mg/m² (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 through 5
  • Irinotecan (Camptosar) to be given after Vincristine (Oncovin)

Chemotherapy, Week 39 (VCPT)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
• Irinotecan (Camptosar) 50 mg/m² (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 through 5
  • Irinotecan (Camptosar) to be given after Vincristine (Oncovin)

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: 2.2 g/m² IV infusion over 30 to 60 minutes once per day on day 1
  • Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
  • Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1

Supportive Medications, Week 41

• Mesna (Mesnex) by the following age-based criteria:
  • Age ≥ 3 years: 440 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age ≥ 1 year: 14.6 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age < 1 year: 7.2 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1

Chemotherapy, Week 42 through 43 Off Chemo

Chemotherapy, Week 44 Evaluation

References

1. COG D9802: Pappo AS, Lyden E, Breitfeld P, Donaldson SS, Wiener E, Parham D, Crews KR, Houghton P, Meyer WH. Two Consecutive Phase II Window Trials of Irinotecan Alone or in Combination With vincristine for the Treatment of Metastatic Rhabdomyosarcoma: The Children's Oncology Group. J Clin Oncol. 2007 Feb 1;25(4):362-9. link to original article PubMed NCT00003955

COG D9802 VAC Alone Arm

Study	Years of enrollment	Evidence
Pappo et al. 2007 (COG D9802)	9/1999-11/2000	Phase 2

Protocol, Irinotecan Window

Chemotherapy, Week 0 (VCPT)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
• Irinotecan (Camptosar) 50 mg/m² (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 through 5
  • Irinotecan (Camptosar) to be given after Vincristine (Oncovin)

Chemotherapy, Week 1 (VCPT)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
• Irinotecan (Camptosar) 50 mg/m² (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 through 5
  • Irinotecan (Camptosar) to be given after Vincristine (Oncovin)

Chemotherapy, Week 2 Off Chemo

Chemotherapy, Week 3 (VCPT)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
• Irinotecan (Camptosar) 50 mg/m² (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 through 5
  • Irinotecan (Camptosar) to be given after Vincristine (Oncovin)

Chemotherapy, Week 4 (VCPT)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
• Irinotecan (Camptosar) 50 mg/m² (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 through 5
  • Irinotecan (Camptosar) to be given after Vincristine (Oncovin)

Chemotherapy, Week 5 Evaluation

Induction

Chemotherapy, Week 6 (VAC)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
• Dactinomycin (Cosmegen) by the following age-based criteria:
  • Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
  • Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
• Cyclophosphamide (Cytoxan) by the following age-based criteria:
  • Age ≥ 3 years: 2.2 g/m² IV infusion over 30 to 60 minutes once per day on day 1
  • Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
  • Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1

Supportive Medications, Week 6

• Mesna (Mesnex) by the following age-based criteria:
  • Age ≥ 3 years: 440 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age ≥ 1 year: 14.6 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age < 1 year: 7.2 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1

Chemotherapy, Week 7 (Vincristine)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 8 (Vincristine)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 9 (VCPT)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
• Irinotecan (Camptosar) 50 mg/m² (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 through 5
  • Irinotecan (Camptosar) to be given after Vincristine (Oncovin)

Chemotherapy, Week 10 (VCPT)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
• Irinotecan (Camptosar) 50 mg/m² (maximum dose of 40 mg/day) IV over 60 minutes once per day on days 1 through 5
  • Irinotecan (Camptosar) to be given after Vincristine (Oncovin)

Chemotherapy, Week 11 (Vincristine)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 12 (VAC)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
• Dactinomycin (Cosmegen) by the following age-based criteria:
  • Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
  • Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
• Cyclophosphamide (Cytoxan) by the following age-based criteria:
  • Age ≥ 3 years: 2.2 g/m² IV infusion over 30 to 60 minutes once per day on day 1
  • Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
  • Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1

Supportive Medications, Week 12

• Mesna (Mesnex) by the following age-based criteria:
  • Age ≥ 3 years: 440 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age ≥ 1 year: 14.6 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age < 1 year: 7.2 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1

Chemotherapy, Week 13 (Vincristine)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 14 Evaluation

Chemotherapy, Week 15 (Vincristine)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 16 (VC)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
• Cyclophosphamide (Cytoxan) by the following age-based criteria:
  • Age ≥ 3 years: 2.2 g/m² IV infusion over 30 to 60 minutes once per day on day 1
  • Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
  • Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1

Supportive Medications, Week 16

• Mesna (Mesnex) by the following age-based criteria:
  • Age ≥ 3 years: 440 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age ≥ 1 year: 14.6 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age < 1 year: 7.2 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1

Chemotherapy, Week 17 (Vincristine)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 18 (Vincristine)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 19 (VC)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
• Cyclophosphamide (Cytoxan) by the following age-based criteria:
  • Age ≥ 3 years: 2.2 g/m² IV infusion over 30 to 60 minutes once per day on day 1
  • Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
  • Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1

Supportive Medications, Week 19

• Mesna (Mesnex) by the following age-based criteria:
  • Age ≥ 3 years: 440 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age ≥ 1 year: 14.6 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age < 1 year: 7.2 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1

Chemotherapy, Week 20 through 22 Off Chemo

Chemotherapy, Week 23 (VAC)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
• Dactinomycin (Cosmegen) by the following age-based criteria:
  • Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
  • Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
• Cyclophosphamide (Cytoxan) by the following age-based criteria:
  • Age ≥ 3 years: 2.2 g/m² IV infusion over 30 to 60 minutes once per day on day 1
  • Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
  • Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1

Supportive Medications, Week 23

• Mesna (Mesnex) by the following age-based criteria:
  • Age ≥ 3 years: 440 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age ≥ 1 year: 14.6 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age < 1 year: 7.2 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1

Chemotherapy, Week 24 (Vincristine)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 25 (Evaluation/Vincristine)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Continuation

Chemotherapy, Week 26 (VAC)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
• Dactinomycin (Cosmegen) by the following age-based criteria:
  • Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
  • Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
• Cyclophosphamide (Cytoxan) by the following age-based criteria:
  • Age ≥ 3 years: 2.2 g/m² IV infusion over 30 to 60 minutes once per day on day 1
  • Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
  • Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1

Supportive Medications, Week 26

• Mesna (Mesnex) by the following age-based criteria:
  • Age ≥ 3 years: 440 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age ≥ 1 year: 14.6 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age < 1 year: 7.2 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1

Chemotherapy, Week 27 (VCR)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 28 Off Chemo

Chemotherapy, Week 29 (VAC)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
• Dactinomycin (Cosmegen) by the following age-based criteria:
  • Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
  • Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
• Cyclophosphamide (Cytoxan) by the following age-based criteria:
  • Age ≥ 3 years: 2.2 g/m² IV infusion over 30 to 60 minutes once per day on day 1
  • Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
  • Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1

Supportive Medications, Week 29

• Mesna (Mesnex) by the following age-based criteria:
  • Age ≥ 3 years: 440 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age ≥ 1 year: 14.6 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age < 1 year: 7.2 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1

Chemotherapy, Week 30 through 31 Off Chemo

Chemotherapy, Week 32 (VAC)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
• Dactinomycin (Cosmegen) by the following age-based criteria:
  • Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
  • Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
• Cyclophosphamide (Cytoxan) by the following age-based criteria:
  • Age ≥ 3 years: 2.2 g/m² IV infusion over 30 to 60 minutes once per day on day 1
  • Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
  • Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1

Supportive Medications, Week 32

• Mesna (Mesnex) by the following age-based criteria:
  • Age ≥ 3 years: 440 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age ≥ 1 year: 14.6 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age < 1 year: 7.2 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1

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 (Vincristine)

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

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: 2.2 g/m² IV infusion over 30 to 60 minutes once per day on day 1
  • Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
  • Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1

Supportive Medications, Week 35

• Mesna (Mesnex) by the following age-based criteria:
  • Age ≥ 3 years: 440 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age ≥ 1 year: 14.6 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age < 1 year: 7.2 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1

Chemotherapy, Week 36 through 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: 2.2 g/m² IV infusion over 30 to 60 minutes once per day on day 1
  • Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
  • Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1

Supportive Medications, Week 38

• Mesna (Mesnex) by the following age-based criteria:
  • Age ≥ 3 years: 440 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age ≥ 1 year: 14.6 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age < 1 year: 7.2 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1

Chemotherapy, Week 39 through 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: 2.2 g/m² IV infusion over 30 to 60 minutes once per day on day 1
  • Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
  • Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1

Supportive Medications, Week 41

• Mesna (Mesnex) by the following age-based criteria:
  • Age ≥ 3 years: 440 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age ≥ 1 year: 14.6 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age < 1 year: 7.2 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1

Chemotherapy, Week 42 through 43 Off Chemo

Chemotherapy, Week 44 Evaluation

References

1. COG D9802: Pappo AS, Lyden E, Breitfeld P, Donaldson SS, Wiener E, Parham D, Crews KR, Houghton P, Meyer WH. Two Consecutive Phase II Window Trials of Irinotecan Alone or in Combination With vincristine for the Treatment of Metastatic Rhabdomyosarcoma: The Children's Oncology Group. J Clin Oncol. 2007 Feb 1;25(4):362-9. link to original article PubMed NCT00003955

Low Risk, all lines of therapy

COG D9602 Subgroup A Clinical Group 1

Regimen

Study	Years of enrollment	Evidence
Raney et al. 2011 (IRSG D9602)	9/1/1997-9/17/2004	Phase 2

Chemotherapy, Week 0

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
• Dactinomycin (Cosmegen) by the following age-based criteria:
  • Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
  • Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1

Chemotherapy, Week 1

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 2

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 3

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
• Dactinomycin (Cosmegen) by the following age-based criteria:
  • Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
  • Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
• No External beam radiotherapy

Chemotherapy, Week 4

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 5

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 6

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
• Dactinomycin (Cosmegen) by the following age-based criteria:
  • Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
  • Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1

Chemotherapy, Week 7

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 8

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 9

• Dactinomycin (Cosmegen) by the following age-based criteria:
  • Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
  • Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1

Chemotherapy, Week 10 and 11 Off Chemo

Chemotherapy, Week 12 Evaluation

12-week cycle for 4 cycles, beginning on weeks 0, 12, 24, 36

References

1. IRSG D9602: Raney RB, Walterhouse DO, Meza JL, Andrassy RJ, Breneman JC, Crist WM, Maurer HM, Meyer WH, Parham DM, Anderson JR. Results of the Intergroup Rhabdomyosarcoma Study Group D9602 protocol, using vincristine and dactinomycin with or without cyclophosphamide and radiation therapy, for newly diagnosed patients with low-risk embryonal rhabdomyosarcoma: a report from the Soft Tissue Sarcoma Committee of the Children's Oncology Group. J Clin Oncol. 2011 Apr 1;29(10):1312-8. link to original article link to PMC article PubMed NCT00002995

COG D9602 Subgroup A Clinical Group 2

Regimen

Study	Years of enrollment	Evidence
Raney et al. 2011 (IRSG D9602)	9/1/1997-9/17/2004	Phase 2

Chemotherapy, Week 0

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
• Dactinomycin (Cosmegen) by the following age-based criteria:
  • Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
  • Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1

Chemotherapy, Week 1

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 2

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 3

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
• Dactinomycin (Cosmegen) by the following age-based criteria:
  • Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
  • Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1

Radiotherapy, Week 3

• External beam radiotherapy 36 Gy given once daily in 20 divided fractions

Chemotherapy, Week 4

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 5

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 6

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 7

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 8

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 9

• Dactinomycin (Cosmegen) by the following age-based criteria:
  • Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
  • Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1

Chemotherapy, Week 10 and 11 Off Chemo

Chemotherapy, Week 12 Evaluation

12-week cycle for 4 cycles, beginning on weeks 0, 12, 24, 36

References

1. IRSG D9602: Raney RB, Walterhouse DO, Meza JL, Andrassy RJ, Breneman JC, Crist WM, Maurer HM, Meyer WH, Parham DM, Anderson JR. Results of the Intergroup Rhabdomyosarcoma Study Group D9602 protocol, using vincristine and dactinomycin with or without cyclophosphamide and radiation therapy, for newly diagnosed patients with low-risk embryonal rhabdomyosarcoma: a report from the Soft Tissue Sarcoma Committee of the Children's Oncology Group. J Clin Oncol. 2011 Apr 1;29(10):1312-8. link to original article link to PMC article PubMed NCT00002995

COG D9602 Subgroup A Clinical Group 3

Regimen

Study	Years of enrollment	Evidence
Raney et al. 2011 (IRSG D9602)	9/1/1997-9/17/2004	Phase 2

Chemotherapy, Week 0

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
• Dactinomycin (Cosmegen) by the following age-based criteria:
  • Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
  • Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1

Chemotherapy, Week 1

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 2

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 3

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
• Dactinomycin (Cosmegen) by the following age-based criteria:
  • Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
  • Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1

Radiotherapy, Week 3

• External beam radiotherapy 45 Gy given once daily in 25 divided fractions

Chemotherapy, Week 4

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 5

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 6

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 7

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 8

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 9

• Dactinomycin (Cosmegen) by the following age-based criteria:
  • Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
  • Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1

Chemotherapy, Week 10 and 11 Off Chemo

Chemotherapy, Week 12 Evaluation

12-week cycle for 4 cycles, beginning on weeks 0, 12, 24, 36

References

1. IRSG D9602: Raney RB, Walterhouse DO, Meza JL, Andrassy RJ, Breneman JC, Crist WM, Maurer HM, Meyer WH, Parham DM, Anderson JR. Results of the Intergroup Rhabdomyosarcoma Study Group D9602 protocol, using vincristine and dactinomycin with or without cyclophosphamide and radiation therapy, for newly diagnosed patients with low-risk embryonal rhabdomyosarcoma: a report from the Soft Tissue Sarcoma Committee of the Children's Oncology Group. J Clin Oncol. 2011 Apr 1;29(10):1312-8. link to original article link to PMC article PubMed NCT00002995

COG D9602 Subgroup B Clinical Group 1

Regimen

Study	Years of enrollment	Evidence
Raney et al. 2011 (IRSG D9602)	9/1/1997-9/17/2004	Phase 2

Chemotherapy, Week 0

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
• Dactinomycin (Cosmegen) by the following age-based criteria:
  • Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
  • Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
• Cyclophosphamide (Cytoxan) by the following age-based criteria:
  • Age ≥ 3 years: 2.2 g/m² IV infusion over 30 to 60 minutes once per day on day 1
  • Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
  • Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1

Supportive Medications, Week 0

• Mesna (Mesnex) by the following age-based criteria:
  • Age ≥ 3 years: 440 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age ≥ 1 year: 14.6 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age < 1 year: 7.2 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
• Filgrastim (Neupogen) 5 mcg/kg SubQ or IV (per institutional policy) once daily starting 24 hours after VAC completion and continued once daily for 10 days or until ANC > 2000/μL

Chemotherapy, Week 1

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 2

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 3

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
• Dactinomycin (Cosmegen) by the following age-based criteria:
  • Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
  • Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
• Cyclophosphamide (Cytoxan) by the following age-based criteria:
  • Age ≥ 3 years: 2.2 g/m² IV infusion over 30 to 60 minutes once per day on day 1
  • Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
  • Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1

Supportive Medications, Week 3

• Mesna (Mesnex) by the following age-based criteria:
  • Age ≥ 3 years: 440 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age ≥ 1 year: 14.6 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age < 1 year: 7.2 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
• Filgrastim (Neupogen) 5 mcg/kg SubQ or IV (per institutional policy) once daily starting 24 hours after VAC completion and continued once daily for 10 days or until ANC > 2000/μL
• No External beam radiotherapy

Chemotherapy, Week 4

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 5

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 6

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
• Dactinomycin (Cosmegen) by the following age-based criteria:
  • Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
  • Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
• Cyclophosphamide (Cytoxan) by the following age-based criteria:
  • Age ≥ 3 years: 2.2 g/m² IV infusion over 30 to 60 minutes once per day on day 1
  • Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
  • Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1

Supportive Medications, Week 6

• Mesna (Mesnex) by the following age-based criteria:
  • Age ≥ 3 years: 440 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age ≥ 1 year: 14.6 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age < 1 year: 7.2 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
• Filgrastim (Neupogen) 5 mcg/kg SubQ or IV (per institutional policy) once daily starting 24 hours after VAC completion and continued once daily for 10 days or until ANC > 2000/μL

Chemotherapy, Week 7

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 8

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 9

• Dactinomycin (Cosmegen) by the following age-based criteria:
  • Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
  • Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
• Cyclophosphamide (Cytoxan) by the following age-based criteria:
  • Age ≥ 3 years: 2.2 g/m² IV infusion over 30 to 60 minutes once per day on day 1
  • Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
  • Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1

Supportive Medications, Week 9

• Mesna (Mesnex) by the following age-based criteria:
  • Age ≥ 3 years: 440 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age ≥ 1 year: 14.6 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age < 1 year: 7.2 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
• Filgrastim (Neupogen) 5 mcg/kg SubQ or IV (per institutional policy) once daily starting 24 hours after AC completion and continued once daily for 10 days or until ANC > 2000/μL

Chemotherapy, Week 10 and 11 Off Chemo

Chemotherapy, Week 12 Evaluation

12-week cycle for 4 cycles, beginning on weeks 0, 12, 24, 36

References

1. IRSG D9602: Raney RB, Walterhouse DO, Meza JL, Andrassy RJ, Breneman JC, Crist WM, Maurer HM, Meyer WH, Parham DM, Anderson JR. Results of the Intergroup Rhabdomyosarcoma Study Group D9602 protocol, using vincristine and dactinomycin with or without cyclophosphamide and radiation therapy, for newly diagnosed patients with low-risk embryonal rhabdomyosarcoma: a report from the Soft Tissue Sarcoma Committee of the Children's Oncology Group. J Clin Oncol. 2011 Apr 1;29(10):1312-8. link to original article link to PMC article PubMed NCT00002995

COG D9602 Subgroup B Clinical Group 2

Regimen

Study	Years of enrollment	Evidence
Raney et al. 2011 (IRSG D9602)	9/1/1997-9/17/2004	Phase 2

Chemotherapy, Week 0

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
• Dactinomycin (Cosmegen) by the following age-based criteria:
  • Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
  • Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
• Cyclophosphamide (Cytoxan) by the following age-based criteria:
  • Age ≥ 3 years: 2.2 g/m² IV infusion over 30 to 60 minutes once per day on day 1
  • Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
  • Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1

Supportive Medications, Week 0

• Mesna (Mesnex) by the following age-based criteria:
  • Age ≥ 3 years: 440 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age ≥ 1 year: 14.6 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age < 1 year: 7.2 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
• Filgrastim (Neupogen) 5 mcg/kg SubQ or IV (per institutional policy) once daily starting 24 hours after VAC completion and continued once daily for 10 days or until ANC > 2000/μL

Chemotherapy, Week 1

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 2

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 3

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
• Dactinomycin (Cosmegen) by the following age-based criteria:
  • Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
  • Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
• Cyclophosphamide (Cytoxan) by the following age-based criteria:
  • Age ≥ 3 years: 2.2 g/m² IV infusion over 30 to 60 minutes once per day on day 1
  • Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
  • Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1

Supportive Medications, Week 3

• Mesna (Mesnex) by the following age-based criteria:
  • Age ≥ 3 years: 440 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age ≥ 1 year: 14.6 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age < 1 year: 7.2 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
• Filgrastim (Neupogen) 5 mcg/kg SubQ or IV (per institutional policy) once daily starting 24 hours after VAC completion and continued once daily for 10 days or until ANC > 2000/μL

Radiotherapy, Week 3

• External beam radiotherapy 36 Gy given once daily in 20 divided fractions

Chemotherapy, Week 4

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 5

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 6

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
• Cyclophosphamide (Cytoxan) by the following age-based criteria:
  • Age ≥ 3 years: 2.2 g/m² IV infusion over 30 to 60 minutes once per day on day 1
  • Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
  • Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1

Supportive Medications, Week 6

• Mesna (Mesnex) by the following age-based criteria:
  • Age ≥ 3 years: 440 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age ≥ 1 year: 14.6 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age < 1 year: 7.2 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
• Filgrastim (Neupogen) 5 mcg/kg SubQ or IV (per institutional policy) once daily starting 24 hours after VAC completion and continued once daily for 10 days or until ANC > 2000/μL

Chemotherapy, Week 7

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 8

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 9

• Dactinomycin (Cosmegen) by the following age-based criteria:
  • Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
  • Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
• Cyclophosphamide (Cytoxan) by the following age-based criteria:
  • Age ≥ 3 years: 2.2 g/m² IV infusion over 30 to 60 minutes once per day on day 1
  • Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
  • Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1

Supportive Medications, Week 9

• Mesna (Mesnex) by the following age-based criteria:
  • Age ≥ 3 years: 440 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age ≥ 1 year: 14.6 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age < 1 year: 7.2 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
• Filgrastim (Neupogen) 5 mcg/kg SubQ or IV (per institutional policy) once daily starting 24 hours after AC completion and continued once daily for 10 days or until ANC > 2000/μL

Chemotherapy, Week 10 and 11 Off Chemo

Chemotherapy, Week 12 Evaluation

12-week cycle for 4 cycles, beginning on weeks 0, 12, 24, 36

References

1. IRSG D9602: Raney RB, Walterhouse DO, Meza JL, Andrassy RJ, Breneman JC, Crist WM, Maurer HM, Meyer WH, Parham DM, Anderson JR. Results of the Intergroup Rhabdomyosarcoma Study Group D9602 protocol, using vincristine and dactinomycin with or without cyclophosphamide and radiation therapy, for newly diagnosed patients with low-risk embryonal rhabdomyosarcoma: a report from the Soft Tissue Sarcoma Committee of the Children's Oncology Group. J Clin Oncol. 2011 Apr 1;29(10):1312-8. link to original article link to PMC article PubMed NCT00002995

COG D9602 Subgroup B Clinical Group 3

Regimen

Study	Years of enrollment	Evidence
Raney et al. 2011 (IRSG D9602)	9/1/1997-9/17/2004	Phase 2

Chemotherapy, Week 0

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
• Dactinomycin (Cosmegen) by the following age-based criteria:
  • Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
  • Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
• Cyclophosphamide (Cytoxan) by the following age-based criteria:
  • Age ≥ 3 years: 2.2 g/m² IV infusion over 30 to 60 minutes once per day on day 1
  • Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
  • Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1

Supportive Medications, Week 0

• Mesna (Mesnex) by the following age-based criteria:
  • Age ≥ 3 years: 440 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age ≥ 1 year: 14.6 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age < 1 year: 7.2 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
• Filgrastim (Neupogen) 5 mcg/kg SubQ or IV (per institutional policy) once daily starting 24 hours after VAC completion and continued once daily for 10 days or until ANC > 2000/μL

Chemotherapy, Week 1

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 2

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 3

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
• Dactinomycin (Cosmegen) by the following age-based criteria:
  • Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
  • Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
• Cyclophosphamide (Cytoxan) by the following age-based criteria:
  • Age ≥ 3 years: 2.2 g/m² IV infusion over 30 to 60 minutes once per day on day 1
  • Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
  • Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1

Supportive Medications, Week 3

• Mesna (Mesnex) by the following age-based criteria:
  • Age ≥ 3 years: 440 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age ≥ 1 year: 14.6 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age < 1 year: 7.2 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
• Filgrastim (Neupogen) 5 mcg/kg SubQ or IV (per institutional policy) once daily starting 24 hours after VAC completion and continued once daily for 10 days or until ANC > 2000/μL

Radiotherapy, Week 3

• External beam radiotherapy 45 Gy given once daily in 25 divided fractions

Chemotherapy, Week 4

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 5

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 6

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
• Cyclophosphamide (Cytoxan) by the following age-based criteria:
  • Age ≥ 3 years: 2.2 g/m² IV infusion over 30 to 60 minutes once per day on day 1
  • Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
  • Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1

Supportive Medications, Week 6

• Mesna (Mesnex) by the following age-based criteria:
  • Age ≥ 3 years: 440 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age ≥ 1 year: 14.6 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age < 1 year: 7.2 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
• Filgrastim (Neupogen) 5 mcg/kg SubQ or IV (per institutional policy) once daily starting 24 hours after VAC completion and continued once daily for 10 days or until ANC > 2000/μL

Chemotherapy, Week 7

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 8

• Vincristine (Oncovin) by the following age-based criteria:
  • Age ≥ 3 years: 1.5 mg/m² (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
  • Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1

Chemotherapy, Week 9

• Dactinomycin (Cosmegen) by the following age-based criteria:
  • Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
  • Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
• Cyclophosphamide (Cytoxan) by the following age-based criteria:
  • Age ≥ 3 years: 2.2 g/m² IV infusion over 30 to 60 minutes once per day on day 1
  • Age ≥ 1 year: 73 mg/kg IV infusion over 30 to 60 minutes once on day 1
  • Age < 1 year: 36 mg/kg IV infusion over 30 to 60 minutes once on day 1

Supportive Medications, Week 9

• Mesna (Mesnex) by the following age-based criteria:
  • Age ≥ 3 years: 440 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age ≥ 1 year: 14.6 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
  • Age < 1 year: 7.2 mg/m² IV infusion at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on day 1
• Filgrastim (Neupogen) 5 mcg/kg SubQ or IV (per institutional policy) once daily starting 24 hours after AC completion and continued once daily for 10 days or until ANC > 2000/μL

Chemotherapy, Week 10 and 11 Off Chemo

Chemotherapy, Week 12 Evaluation

12-week cycle for 4 cycles, beginning on weeks 0, 12, 24, 36

References

1. IRSG D9602: Raney RB, Walterhouse DO, Meza JL, Andrassy RJ, Breneman JC, Crist WM, Maurer HM, Meyer WH, Parham DM, Anderson JR. Results of the Intergroup Rhabdomyosarcoma Study Group D9602 protocol, using vincristine and dactinomycin with or without cyclophosphamide and radiation therapy, for newly diagnosed patients with low-risk embryonal rhabdomyosarcoma: a report from the Soft Tissue Sarcoma Committee of the Children's Oncology Group. J Clin Oncol. 2011 Apr 1;29(10):1312-8. link to original article link to PMC article PubMed NCT00002995