Gene Therapy Clinical Trials
Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation, Radiation Therapy, and/or Surgery in Treating Patients With Ewing's Sarcoma
RATIONALE: Drugs used in chemotherapy use 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. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and kill more tumor cells. It is not yet known if combination chemotherapy is more effective with or without radiation therapy and/or surgery in treating Ewing's sarcoma.
PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens to see how well they work when given with or without peripheral stem cell transplantation, radiation therapy, and/or surgery in treating patients with Ewing's sarcoma.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- biological: dactinomycin
- drug: vincristine sulfate
- procedure: autologous hematopoietic stem cell transplantation
- radiation: radiation therapy
- drug: busulfan
- drug: doxorubicin hydrochloride
- drug: etoposide
- drug: ifosfamide
- drug: melphalan
- procedure: conventional surgery
Eligibility
DISEASE CHARACTERISTICS:
- Histologically confirmed tumor of the Ewing's family of bone or soft tissue
- Ewing's sarcoma
- Peripheral primitive neuroectodermal tumor
- Disease meeting one of the following criteria:
- Resectable localized disease (tumor volume less than 200 mL)
- Localized disease previously resected at diagnosis
- Unresectable disease (at least 200 mL tumor volume) but radiotherapy as local
control can be delayed
- Localized disease with early radiotherapy required
- Pulmonary and/or pleural metastases only
- Extrapulmonary/pleural metastases (skeleton, bone marrow, lymph nodes)
- No more than 45 days since definitive biopsy
PATIENT CHARACTERISTICS:
Age:
- Under 50
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Renal function normal
- Glomerular filtration rate at least 60 mL/min
Cardiovascular:
- Normal cardiac function
- Fractional shortening at least 29%
- Ejection fraction at least 40%
Other:
- No medical, psychiatric, or social condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- See Disease Characteristics
Ages Eligible for Study
N/A - 49 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Peds Hem/Onc CRAs
650-723-5535
Not Recruiting