Randomized Study of Vincristine, Dactinomycin and Cyclophosphamide (VAC) versus VACAlternating with Vincristine and Irinotecan (VI) for Patients with Intermediate-Risk Rhabdomyosarcoma (RMS)

IRB-HSR# 13667
Service: Cancer (Children) | Category: Cancer (Oncology), Pediatrics
Adult Enrollment: No | Minor Enrollment: No
Primary Investigator: Kimberly Dunsmore, M.D.

Contact Information

Contact: Candace Hudspeth
Phone: 434.982.1091
E-mail: ckh3k@virginia.edu

Clinical Trial Description

UVA Health System, Department of Pediatrics seeks: children, adolescents, women and men with intermediate-risk, newly diagnosed rhabdomyosarcoma who are less than 50 years of age at the time of enrollment for research study.

The overall goals of the study are: (a) to see if the investigational combination (vincristine, dactinomycin and cyclophosphamide [VAC] plus vincristine and irinotecan [VI]) is better than the standard chemotherapy (VAC) alone for treating intermediate risk rhabdomyosarcoma, (b) to compare the effects, of an investigational combination (VAC plus VI) of chemotherapy, (c) to compare a new schedule (starting at week 4) for giving radiation therapy to the standard schedule (starting at week 13), and (d) to compare the side effects and efficacy of a slightly lower dose of cyclophosphamide to the higher standard dose.

The study involves blood draws (which test for things such as blood counts and kidney and liver function), physical exams, urinalyses, lumbar puncture, bone marrow aspirate and biopsy, CT/MRI, bone and PET (optional) scans, and taking FDA approved chemotherapy agents. With the exception of the optional PET scan, all testing done on the study is considered standard of care. The length of the visits will be comparable to or shorter than the length of the visits you would receive for standard of care treatment. Patients are expected to receive treatment on this study for 43 weeks. Data will be collected on patients for 10 years after the study closes to new patient enrollment.

You and/or your insurance will be billed for all study related medication, tests, treatment, and procedures.

Compensation

No compensation is provided for this study.