Summary
**STUDY IS CLOSED at this site** This study is for patients with high-risk rhabdomyosarcoma, a type of cancer that’s hard to treat. Current treatments don’t work well for many patients. A medicine called vinorelbine has helped some people after treatment. This study will test if using vinorelbine earlier and for longer can help more patients survive. Two different drug plans will be tested. The study will also check if the new plan is safe and learn more about how the cancer works.
Description
Patients with high-risk rhabdomyosarcoma (HR-RMS) continue to have poor outcomes with 3-year event free survival (EFS) rates of 30% or less despite dose intensification on the most recent cooperative group RMS trials. Vinorelbine (VINO) has demonstrated clinical activity in RMS patients with relapsed and refractory disease and has been shown to provide a survival benefit when given as maintenance chemotherapy along with oral cyclophosphamide for a select group of patients who have achieved a complete remission. In an attempt to improve long term survival for patients with HR-RMS, ARST2031 will evaluate vinca alkaloid intensification and maintenance therapy. Patients will be randomly assigned to vincristine, dactinomycin and cyclophosphamide (VAC) followed by maintenance with vinorelbine and oral cyclophosphamide (VINO-CPO) or vinorelbine, dactinomycin and cyclophosphamide (VINO-AC) followed by maintenance with VINO-CPO. Safety and feasibility of VINO-AC will be assessed in the first 8 patients prior to randomization. Correlative biology studies will be performed.
Principal Investigator
Faculty Contact
Kristi Sutphin - kristi.sutphin@vandaliahealth.org
Research Contact
Sana Farooki - sana.farooki@vandaliahealth.org