ARST2031: A Randomized Phase 3 Trial of Vinorelbine, Dactinomycin, and Cyclophosphamide (VINO-AC) Plus Maintenance Chemotherapy with Vinorelbine and Oral Cyclophosphamide (VINO-CPO) vs Vincristine, Dactinomycin and Cyclophosphamide (VAC) plus VINO-CPO

The overall goals of this study are: 1) To find out if vinorelbine can be given safely in combination with vincristine, dactinomycin, and cyclophosphamide (together called VINO-AC with vincristine). This is Part 1 of the study. 2) To compare the effects, good and/or bad, vinorelbine has on people with high risk RMS. This is Part 2 of the study. 3) To find out if adding maintenance therapy will help get rid of the cancer and/or lower the chance that the cancer comes back. This is Part 2 of the study.

Are you Eligible? (Inclusion Criteria)

• Patients must be ≤ 50 years of age at the time of enrollment
• Patients must have newly diagnosed RMS of any subtype, except adult-type pleomorphic, based upon institutional histopathologic classification
• Patients must meet organ function requirements as defined in the study protocol
• Patients must also meet all other eligibility criteria as outlined in the study protocol