Combination Chemotherapy Plus Radiation Therapy in Treating Adult Patients With Brain Cancer

Eastern Cooperative Oncology Group33 enrolled

Overview

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. Combining more than one drug and combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy in treating adult patients with brain cancer.

OBJECTIVES: * Determine the complete and partial response rate of patients with adult medulloblastoma, primitive neuroectodermal tumor, or disseminated ependymoma treated with preradiation combination chemotherapy. * Determine the progression free survival and overall survival of these adult patients treated with combination chemotherapy followed by craniospinal radiation. * Determine the toxic effects associated with this treatment in these patients. OUTLINE: Patients receive cisplatin IV over 6 hours, etoposide IV, and vincristine IV over 1-2 minutes on day 1; etoposide IV and cyclophosphamide IV over 1-2 hours on days 2-3; filgrastim (G-CSF) subcutaneously (SC) on days 4-13; and vincristine IV over 1-2 minutes on day 15. Treatment repeats every 42 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Within 4-6 weeks after the last chemotherapy course, patients undergo radiotherapy 5 days a week for 6 to 7 weeks. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5-10 years. PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study within 3 years.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Brain and Central Nervous System Tumors

Interventions

filgrastimBIOLOGICAL

cisplatinDRUG

cyclophosphamideDRUG

etoposideDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically confirmed central nervous system cancer including: * Medulloblastoma with either local residual disease of greater than 1 cm\^2 on MRI following resection or evidence of metastases (M1-4) * Other primitive neuroectodermal tumors * Ependymoma with evidence of subarachnoid metastases * Must have less than 1 cm of midline shift or no acute elevated intercranial pressure PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * WBC greater than 4,000/mm\^3 * Platelet count greater than 125,000/mm\^3 * Hemoglobin greater than 10 g/dL * No preexisting hematologic condition that would increase toxicity or limit ability to comply with evaluations and follow-up Hepatic: * Bilirubin less than 2 times upper limit of normal (ULN) * SGOT less than 2 times ULN * Alkaline phosphatase less than 2 times ULN * No preexisting hepatic condition that would increase toxicity or limit ability to comply with evaluations and follow-up Renal: * Creatinine greater than 70 mL/min * No preexisting renal condition that would increase toxicity or limit ability to comply with evaluations and follow-up Pulmonary: * No history of significant pulmonary disease or, if there is preexisting pulmonary disease, then DLCO greater than 60% of predicted * No preexisting pulmonary condition that would increase toxicity or limit ability to comply with evaluations and follow-up Other: * No preexisting psychiatric condition that would increase toxicity or limit ability to comply with evaluations and follow-up * No prior or concurrent malignancies within the past 5 years except curatively treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy Endocrine therapy: * No increasing doses of steroids for intracranial disease within 3 days of registration Radiotherapy: * No prior radiotherapy Surgery: * 10-28 days since prior surgical resection OR * At least 5 days since prior biopsy

Locations (14)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Veterans Affairs Medical Center - Lakeside Chicago

Chicago, Illinois, United States

Data from ClinicalTrials.gov

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