The Treatment of One or Two Supratentorial Brain Metastases With Surgical Resection and BCNU-Polymer Wafers
- 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
- Determine the incidence and severity of cognitive function loss of these patients on
- 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
Alessandro Olivi, MD
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government
|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|