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ARST1431 A Randomized Phase 3 Study of Vincristine, Dactinomycin, Cyclophosphamide (VAC) Alternating with Vincristine and Irinotecan (VI) Versus VAC/VI Plus Temsirolimus (TORI, Torisel, NSC# 683864) in Patients with Intermediate Risk (IR) Rhabdomyosarcoma

NCT02567435

A Randomized Phase 3 Study of Vincristine, Dactinomycin, Cyclophosphamide (VAC) Alternating with Vincristine and Irinotecan (VI) Versus VAC/VI Plus Temsirolimus (TORI, Torisel, NSC# 683864) in Patients with Intermediate Risk (IR) Rhabdomyosarcoma (RMS)

Associated Conditions

Bone and Soft Tissue Cancer

Principal Investigator

Sponsor

Children's Oncology Group

Subjects in Part 1 (Dose Finding Phase) Only: The overall goals of this study are: (1) to compare the effects, good and/or bad, of a new combination of chemotherapy using VAC/VI plus temsirolimus; (2) to find if adding the drug temsirolimus to VAC/VI therapy will get rid of the cancer better than VAC/VI by itself. Subjects in Part 2 (Regimen A and Regimen B Randomization) Only: The overall goals of this study are: (1) to compare the effects, good and/or bad, of a new combination of chemotherapy using VAC/VI plus temsirolimus; (2) to find if adding the drug temsirolimus to VAC/VI therapy will get rid of the cancer better than VAC/VI by itself; (3) to find out if adding maintenance therapy after VAC/VI therapy with or without temsirolimus will get rid of the cancer better than VAC/VI by itself. Patients Eligible for Regimen C, VAC/VA Only: The overall goal of this study is to see if a shorter length of treatment and lower doses of cyclophosphamide used together with current standard doses of vincristine and dactinomycin can be as effective in curing subjects as using the current standard doses of all three drugs, and cause fewer late effects.