High-Risk Rhabdomyosarcoma Study: VINO-AC Plus Maintenance Chemotherapy With VINO-CPO vs. VAC plus VINO-CPO Maintenance
A Randomized Phase III 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 Maintenance in Patients with High-Risk Rhabdomyosa...
About
Protocol Description
Rhabdomyosarcoma (RMS) is the most common soft-tissue sarcoma in children and adolescents. While patients with low- or intermediate-risk RMS have a favorable prognosis, patients with high-risk RMS (HR-RMS) continue to have poor outcomes. This study hopes to improve the outcomes of patients with HR-RMS. In this study, patients will be randomized between two chemotherapy regimens and maintenance will be added to each arm.
COG# ARST2031
Eligibility Criteria
Inclusion Criteria
- Patients with newly diagnosed RMS of any subtype (except adult-type pleomorphic) based upon institutional pathologic classification are eligible to enroll based on stage, group and age, further described in the protocol.
- Patients must be ≤ 50 years of age at the time of enrollment.
- Must have adequate renal and liver function as defined by the protocol.
Exclusion Criteria
- Patients with RMS that is considered a second malignancy and previous cancer(s) that were treated with chemotherapy and/or radiation
- Patients with central nervous system involvement of RMS
- Pregnant or lactating female patients
See Protocol Section 3 for a complete comprehensive list of inclusion and exclusion criteria.
Primary Investigator
Dr. Glenn Edwards is the section chief of Pediatric Hematology/Oncology, as well as the Children's Oncology Group's principal investigator for Carilion Clinic. He has over 30 years of clinical experience and is board certified by the American Board of Pediatrics in Pediatrics and Pediatric Hematology/Oncology. He completed his fellowship at Walter Reed Army Medical Center and completed his internship and residency at Tripler Army Medical Center.
Contact Information
Wendy McCarty, C.C.R.P.
Clinical Research Coordinator II
