Carmustine Implants in Treating Patients With Brain Metastases

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. Giving the drugs in different ways may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of implanted carmustine wafers in treating patients who have brain metastases and who are undergoing surgery to remove the tumor.

Detailed Description
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OBJECTIVES: Determine the local recurrence rate in patients with supratentorial metastatic brain tumors undergoing surgical resection treated with polifeprosan 20 with carmustine implant (Gliadel wafers). Determine the incidence and time to recurrence at distant sites within the CNS in these patients after this treatment. Determine the median, 6-month, 1-year, and 2-year survival of these patients on this regimen. Determine the incidence and severity of cognitive function loss of these patients on this regimen. Determine the incidence and severity of CNS and systemic toxic effects of these patients on this regimen. OUTLINE: Patients receive up to 8 polifeprosan 20 with carmustine implants (Gliadel wafers) implanted in the resected tumor cavity. Patients are followed on day 7 or day of discharge, at 1 month, 3 months, every 3 months for 21 months, and then for survival. PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 30 months.

Official Title
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The Treatment of One or Two Supratentorial Brain Metastases With Surgical Resection and BCNU-Polymer Wafers

Conditions
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Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Drug: polifeprosan 20 with carmustine implant
* Procedure: conventional surgery


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Supratentorial brain metastases for which surgery is recommended Solitary, unilateral, intracranial mass consistent with metastasis on MRI scan OR Two brain lesions consistent with metastases on MRI scan Lesions must be accessible through a single craniotomy Metastatic lesions clearly distinct from tumor bed of any benign lesions Intraoperative frozen section diagnosis of metastatic tumor from CNS lesion No prior malignant intracranial neoplasm No lesion(s) in the brainstem No open communication of the resection cavity with the ventricle following resection PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 60-100% Life expectancy At least 3 months Hematopoietic No concurrent hematologic disorders Hepatic No concurrent hepatic disease Renal No concurrent renal disease Cardiovascular No concurrent cardiac disease Pulmonary No concurrent pulmonary disorders Other Not pregnant or nursing Fertile patients must use effective contraception Mini mental score at least 15 No known hypersensitivity to carmustine or Gliadel wafers No other serious concurrent medical illness or infection PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy No prior cranial irradiation Surgery See Disease Characteristics No prior surgery involving brain metastases or primary brain tumor(s) (except for benign intracranial lesions such as pituitary adenoma, meningioma, or schwannoma) Other Concurrent systemic therapy allowed

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- |
|Drug: polifeprosan 20 with carmustine implant|nan|
|Procedure: conventional surgery|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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unspecified adult solid tumor, protocol specific, tumors metastatic to brain