Comparison of Combination Chemotherapy Regimens in Treating Patients With Ewing's Sarcoma or Neuroectodermal Tumor

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy 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. It is not yet known which chemotherapy regimen combined with radiation therapy and/or surgery is more effective in treating Ewing's sarcoma or primitive neuroectodermal tumor.

PURPOSE: Randomized phase III trial to compare the effectiveness of different chemotherapy regimens combined with radiation therapy and/or surgery in treating patients who have Ewing's sarcoma or primitive neuroectodermal tumor.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Oncology Group
• Collaborators: National Cancer Institute (NCI); Southwest Oncology Group
• Treatments: Cyclophosphamide; Doxorubicin; Etoposide; Etoposide phosphate; Ifosfamide; Isophosphamide mustard; Lenograstim; Liposomal doxorubicin; Sargramostim; Vincristine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed localized Ewing's sarcoma or peripheral primitive neuroectodermal tumor (PNET) of the bone or soft tissues

• Diagnostic biopsy of primary tumor within 30 days of study

• Paraspinal or bony skull tumors of extradural origin allowed

• No intradural soft tissue tumors

• Askin's tumor of the chest wall allowed

• Chest wall tumors with ipsilateral pleural effusions or ipsilateral pleural-based secondary tumor nodules allowed

• No contralateral pleural effusions

• No metastatic disease or distant node involvement

• One pulmonary or pleural nodule greater than 1 cm in diameter OR more than 1 nodule greater than 0.5 cm in diameter are considered pulmonary metastasis

• Solitary lung nodules of 0.5-1 cm OR multiple nodules of 0.3-0.5 cm allowed unless biopsy positive for tumor

• Light microscopic appearance (hematoxylin and eosin stained) consistent with Ewing's sarcoma or peripheral PNET

• No immunohistochemical or ultrastructural evidence of rhabdomyosarcoma

• No esthesioneuroblastoma

• Clinically or pathologically involved regional lymph nodes allowed

• No CNS involvement

PATIENT CHARACTERISTICS:

Age:

• 50 and under at diagnosis

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Bilirubin no greater than 1.5 mg/dL

Renal:

• Creatinine normal for age

• Creatinine clearance or isotope glomerular filtration rate at least 75 mL/min

Cardiovascular:

• Shortening fraction at least 28% by echocardiography OR

• Ejection fraction at least 55% by radionuclide angiogram

Other:

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No other prior malignancy except skin cancer diagnosed at least 5 years ago and currently in remission

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior immunotherapy for skin cancer

• No concurrent sargramostim (GM-CSF)

• No concurrent pegfilgrastim

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy

Surgery:

• Prior complete or partial excision of primary tumor allowed