The Treatment of One or Two Supratentorial Brain Metastases With Surgical Resection and BCNU-Polymer Wafers
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.
Interventional
Primary Purpose: Treatment
Alessandro Olivi, MD
Study Chair
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government
CDR0000067044
NCT00003878
April 2002
April 2003
Name | Location |
---|---|
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
Emory University Hospital - Atlanta | Atlanta, Georgia 30322 |
Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama 35294-3300 |
Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
Henry Ford Hospital | Detroit, Michigan 48202 |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |