Carmustine Implants in Treating Patients With Brain Metastases

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.

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