Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
The Treatment of One or Two Supratentorial Brain Metastases With Surgical Resection and BCNU-Polymer Wafers
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.
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.
;
Primary Purpose: Treatment
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