Evaluate novel agents with intensive multi-agent interval compressed reaction for high-risk rhabdomyosarcoma

eagle-i ID

Resource Type

Properties

1. Intervention

   Cixutumumab

2. Intervention

   Temozolomide

3. Intervention

   Vincristine/irinotecan

4. Additional Topic(s)

   Antineoplastic combined chemotherapy

5. Resource Description

   This trial evaluates the addition of novel therapeutic agents to the intensive chemotherapy used in the previous COG trial for metastatic rhabdomyosarcoma. As in the previous trial, patients enrolled in this study will be treated with an intensified chemotherapy regimen. This study will assess the feasibility of adding new agents to the chemotherapy backbone. Patients in Pilot 1 will have cixutumumab added to their weekly chemotherapy. Patients in Pilot 2 will have temozolomide added to their vincristine/irinotecan cycles. Patients in Pilot 3 will receive both cixutumumab and temozolomide with the chemotherapy.

6. Contact

   Berenberg, Jeffrey

7. PI

   Wilkinson, Robert, M.D.

8. Topic

   rhabdomyosarcoma

9. Study Population

   Patients must have newly diagnosed (within 42 days of enrollment), biopsy-confirmed metastatic rhabdomyosarcoma (RMS) or ectomesenchymoma, including the following: Embryonal RMS (for patients 10 to 49 years of age) ; Alveolar RMS or ectomesenchymoma (for patients under 50 years of age)

10. Funded by

    Children's Oncology Group

11. Phase

    Phase 0 clinical trial

12. Performed by

    Clinical Protocol & Data Management Shared Resource