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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase II Trial of Preradiation Multiagent Chemotherapy for Adults With Poor Risk Medulloblastoma, PNET, and Disseminated Ependymoma

Conditions
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Brain and Central Nervous System Tumors

Intervention / Treatment
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* Biological: filgrastim
* Drug: cisplatin
* Drug: cyclophosphamide
* Drug: etoposide
* Drug: vincristine sulfate
* Procedure: adjuvant therapy
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: filgrastim|nan|
|Drug: cisplatin|nan|
|Drug: cyclophosphamide|nan|
|Drug: etoposide|nan|
|Drug: vincristine sulfate|nan|
|Procedure: adjuvant therapy|nan|
|Radiation: radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adult medulloblastoma, adult anaplastic ependymoma, adult ependymoma, adult supratentorial primitive neuroectodermal tumor (PNET)