Pediatrics

Category: Cancer (Oncology), Pediatrics, HIC#12680
Title:
Vincristine, Dactinomycin, and Lower Doses of Cyclophosphamide With or Without Radiation Therapy for Patients with Newly Diagnosed Low-Risk Embryonal/Botryoid/Spindle Cell Rhabdomyosarcoma
Contact:Candy Hudspeth
Phone:(434)982-1091
E-mail:ckh3k@virginia.edu

UVa Health System, Department of Pediatrics seeks: children, adolescents, women and men with newly diagnosed embryonal rhabdomyosarcoma (or a related type called botryoid or spindle cell rhabdomyosarcoma or embryonal ectomesenchymoma) that has a low risk of returning after treatment for research study. The patient must be less than 50 years old at the time of enrollment.

The standard treatment for rhabdomyosarcoma consists of chemotherapy (treatment with anti-cancer drugs), surgery, and/or radiation therapy (the use of high energy X-rays to kill cancer cells). The purpose of the study is to find out the most effective treatment with the least amount of therapy that will still cure subjects with low risk rhabdomyosarcoma. We want to know this because although chemotherapy and radiation therapy can cure low-risk rhabdomyosarcoma they can also have side effects on patients later in life (late effects).

The study involves taking FDA approved chemotherapy agents, blood draws, physical exams, urinalyses, lymph node biopsy (in certain situations), pregnancy test (for females of child bearing age), CT/MRI and bone scans. The patient may also receive radiation therapy and/or surgery. Treatment option subset 1 requires 23 study visits over 24 weeks. Four of these visits will take 3-4 hours longer than if you were receiving non-study treatment. However, the total length of treatment will be shortened from 32 to 24 weeks. Data will be collected for study purposes for 10 years after treatment is completed.

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 # 12680 (COG ARST0331)

Principal Investigator: Kimberly P. Dunsmore, MD

Primary Investigator: Dunsmore Kimberly, P
Department: Pediatrics
Accepts adult enrollment :YES
Accepts minor enrollment :YES