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Therapeutic Areas: Oncology
Disease Category: Cancer/Chemotherapy

Trial Information

Clinical trials for patients wiht intermediate-risk, newly diagnosed Rhabdomyosarcoma

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.
No compensation is provided for this study.

Contact Information:
For more information please contact:
Candace Hudspeth, CCRC
Tel: 434-982-1091 Email: ckh3k@virginia.edu
IRB-HSR # 13667 (COG ARST0531)

Principal Investigator: Kimberly P. Dunsmore, MD



www.healthsystem.virginia.edu/clinical_trials

Candy Hudspeth CCRC
University of Virginia
School of Medicine
Hematology/Oncology, Pediatrics
Box 800334
Charlottesville, VA 22908
Phone: 434-982-1091
EMail: ckh3k@virginia.edu

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