Trials / Completed
CompletedNCT00003878
Carmustine Implants in Treating Patients With Brain Metastases
The Treatment of One or Two Supratentorial Brain Metastases With Surgical Resection and BCNU-Polymer Wafers
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- New Approaches to Brain Tumor Therapy Consortium · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | polifeprosan 20 with carmustine implant | |
| PROCEDURE | conventional surgery |
Timeline
- Start date
- 2002-04-01
- Completion
- 2003-04-01
- First posted
- 2003-01-27
- Last updated
- 2013-06-21
Locations
11 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00003878. Inclusion in this directory is not an endorsement.