To determine the feasibility of: administering IMC-A12 in combination with multi-agent intensive chemotherapy regimen for the treatment of high-risk rhabdomyosarcoma; adding temozolomide to vincristine/irinotecan cycles to assess the immediate and short term side effects of delivery with irradiation in patients with high-risk rhabdomyosarcoma; administering IMC-A12 in combination with multi-agent intensive chemotherapy regimen including temozolomide with vincristine/irinotecan cycles.
PATIENTS MUST BE ELIGIBLE FOR AND ENROLLED ON D9902 PRIOR TO ENROLLMENT ON THIS PROTOCOL.
- For Embryonal RMS: Age greater than or equal to 10 years and less than 50 years at time of enrollment: For alveolar RMS or ectomesenchymoma: Age less than 50 years at time of enrollment
- Newly diagnosed, biopsy-proven metastatic rhabdomyosarcoma (RMS) or ectomesenchymoma (Stage IV, Clinical Group IV)
- Patients must have a performance status corresponding to ECOG scores of 0, 1, or 2. Use Karnofsky for patients greater than 16 years and Landsky for patients less than or equal to 16 years of age
- No prior chemotherapy or radiotherapy except for use of corticosteroids or emergent radiation therapy
- Must have adequate renal, liver, cardiac, and hematological function (as defined in Section 3.2.6)
- Sexually active patients of childbearing potential must agree to use effective contraception during therapy and for at least 3 months after the last dose of IMC-A12 (Pilots 1 & 3)
- Patients with metastatic embryonal RMS and age less than 10 years are NOT eligible
- Female patients who are pregnant or breastfeeding are NOT eligible. Female patients who are lactating must agree to stop breastfeeding to participate in this study
- Patients receiving growth hormone therapy are NOT eligible
- Patients with known Type I or Type II diabetes mellitus are NOT eligible for Pilot 1 or Pilot 3.
- Patients with evidence of uncontrolled infection are NOT eligible