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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00003878
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 2
Start date April 2002
Completion date April 2003

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