Site for 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 (RMS)

Brief description of study

The purpose of the study is to determine the outcome for people with intermediate risk Rhabdomyosarcoma (RMS) by adding an experimental drug called temsirolimus to vincristine, dactinomycin, cyclophosphamide and irinotecan (together called VAC/VI therapy). Researchers also want to find out if we can improve the outcome for subjects with intermediate risk RMS by extending the traditional treatment to include a treatment phase called maintenance therapy. Temsirolimus is an experimental anticancer drug that has not been approved by the Food and Drug Administration (FDA) for use in treating intermediate risk RMS. Temsirolimus has been approved by the FDA since March 2007 for adults with renal cell carcinoma, the most common form of kidney cancer in adults. The study drug temsirolimus is investigational, which means that it has not been approved by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test this agent in the current trial.

Clinical Study Identifier: s19-01597 Identifier: NCT02567435

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