Clinical Trial Title Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Rhabdomyosarcoma
Trial Status Closed to Enrollment
Start Date 05/14/2008
Location randall-childrens-hospital-at-legacy-emanuel
Trial Type Pediatric Cancer (Oncology)
Specific Condition Rhabdomyosarcoma (Intermediate Risk)
Description This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work when given together with radiation therapy in treating patients with newly diagnosed rhabdomyosarcoma. Drugs used in chemotherapy, such as vincristine sulfate, dactinomycin, cyclophosphamide, and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective when given together with radiation therapy in treating patients with rhabdomyosarcoma.

Eligibility Criteria All patients must enroll on D9902 prior to enrollment on ARST0531 (refer to D9902 for requirements of tissue submission and time limitations for submission)

The results of rapid central review as part of D9902 must be received prior to Week 4 of protocol therapy

Patients must start protocol therapy within 42 days of the date of the pathology report that establishes the diagnosis of rhabdomyosarcoma (RMS)

Age: < 50 years at the time of enrollment

Newly diagnosed embryonal RMS, botryoid or spindle cell variants of embryonal RMS, ectomesenchymoma, or alveolar RMS are eligible for this study

Enrollment on D9902 to confirm local histologic diagnosis with central pathology review is required

Patients may be enrolled on ARST0531 and start protocol treatment prior to receipt of central pathology review results

Intermediate risk RMS is defined as: a) embryonal, botryoid, or spindle cell RMS, or ectomesenchymoma: Stage 2 or 3 and Group III OR b) alveolar RMS Stage 1-3 and Group I-III

Patients who have received prior chemotherapy (excluding steroids) or radiation therapy, except for patients transferring from ARST0331 (low-risk study), are not eligible

Adequate kidney, liver, and bone marrow function

No evidence of uncontrolled infection
IRB Number

Study status is:
Completed: The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).
Principal Investigator Janice Olson, MD
Contact Name Children's Cancer and Blood Disorders Program
Contact Phone (503) 276-9300
Contact Fax
Contact E-Mail