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 IND# 122782) in Patients with Intermediate Risk (IR) Rhabdomyosarcoma | NYU Langone Health

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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 IND# 122782) in Patients with Intermediate Risk (IR) Rhabdomyosarcoma

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

Conditions:
Intermediate Risk Rhabdomyosarcoma
Age: Between 1 years - 40 years
Gender: Male or Female

Other Inclusion Criteria:

1. Patients with newly diagnosed RMS of any subtype, except adult-type pleomorphic. 2. Patients must have sufficient tissue available for the required biology study. 3. Feasibility Phase: Patients must be < 21 years of age at the time of enrollment. Efficacy Phase: Patients must be = 40 years of age at the time of enrollment.

You may not be eligible for this study if the following are true:

1. Patients who have previously received TORI, another mTOR inhibitor, or any other investigational agent. 2. Patients who have received any chemotherapy (excluding steroids) and/or radiation therapy prior to this enrollment. 3. Patients with uncontrolled hyperglycemia. Patients with uncontrolled hyperlipidemia.