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Vincristine, Dactinomycin, and Lower Doses of Cyclophosphamide in Patients with Newly Diagnosed Low-Risk Embryonal/Botryoid Rhabdomyosarcoma

[Protocol 05-032]

Full Title :

COG ARST0331, VINCRISTINE, DACTINOMYCIN, AND LOWER DOSES OF CYCLOPHOSPHAMIDE WITH OR WITHOUT RADIATION THERAPY FOR PATIENTS WITH NEWLY DIAGNOSED LOW-RISK EMBRYONAL/BOTRYOID RHABDOMYOSARCOMA

Purpose :

Low-risk embryonal/botryoid rhabdomyosarcoma can usually be cured with a combination of chemotherapy, surgery, and/or radiation therapy. But chemotherapy and radiation therapy can cause bad side effects later in life, including growth delays, infertility, and increased risk of second cancers. This study is being performed to determine the most effective treatment with the least amount of therapy that will still cure patients with low-risk rhabdomyosarcoma.

Results of past research studies of low-risk rhabdomyosarcoma patients showed that using three chemotherapy medicines (cyclophosphamide, vincristine, and dactinomycin) helps to cure more patients, but that the high doses of cyclophosphamide used in these past studies can cause late effects. Investigators in the current study will see if lower doses of cyclophosphamide are effective when used together with the current standard doses of the drugs vincristine and dactinomycin, if the length of therapy can be shortened, and if the incidence of bad late effects can be decreased.

Eligibility :

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

• Patients must be newly diagnosed with low-risk embryonal rhabdomyosarcoma, botryoid or spindle cell variants of this disease, or embryonal ectomesenchymoma that has not yet been treated with chemotherapy or radiation therapy.
• Patients must be under age 50.

For more information and to see if your child is or you are eligible for this study, please contact Dr. Leonard H. Wexler at 212-639-7990.