Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
unspecified adult solid tumor, protocol specific, tumors metastatic to brain
Brief summary
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
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.
Interventions
PROCEDUREconventional surgery
Sponsors
National Cancer Institute (NCI)
New Approaches to Brain Tumor Therapy Consortium
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Countries
United States
Outcome results
None listed