Current Research: Pediatric Hematology-Oncology

ARST0331 -- Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Drugs used in chemotherapy, such as vincristine, dactinomycin, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. It is not yet known which treatment regimen is more effective in treating low-risk rhabdomyosarcoma.

This phase III trial is studying how well combination chemotherapy and radiation therapy work in treating patients with newly diagnosed low-risk rhabdomyosarcoma.

Eligibility

Patients may be eligible for this trial if:

• Histologically confirmed newly diagnosed embryonal rhabdomyosarcoma (RMS), botryoid or spindle cell variants of embryonal RMS, or embryonal ectomesenchymoma
• Prior staging ipsilateral retroperitoneal lymph node dissection required for all patients age 10 and over with paratesticular tumors and patients under 10 years of age with clinically or radiographically involved lymph nodes (except when extensive lymph node involvement is identified by imaging studies)
• None of the following diagnoses:
  • Intermediate-risk embryonal RMS
  • Metastatic embryonal RMS
  • Alveolar RMS
  • Undifferentiated sarcoma
  • RMS not otherwise specified (NOS)
  • Other soft tissue sarcoma, including sarcoma NOS
• Prior enrollment on clinical trial COG-D9902
• Under 50 years of age
  • No infants who would not be able to receive study radiotherapy, in the opinion of the treating physician
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No uncontrolled infection
• No prior chemotherapy (except for patients treated on the related intermediate-risk study)
• Prior steroids allowed
• No prior radiotherapy

Trial Sponsor

• Eastern Cooperative Oncology Group (ECOG)

Project Begin Date

• Oct 2004

Tentative Project End Date

• Aug 2010

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Revised March 31, 2009.   Please send comments, suggestions or questions about this page to Goldei Posey, gposey@mcg.edu .