PHASE I, OPEN LABEL, MULTICENTER DOSE ESCALATION STUDY OF GLIADEL IN PATIENTS WITH RECURRENT MALIGNANT GLIOMA
- Determine the safety of polifeprosan 20 with carmustine implant (GLIADEL) in patients
undergoing surgery for recurrent malignant glioma.
OUTLINE: This is a dose escalation study.
All patients undergo maximal tumor resection. At the time of surgery, groups of 6 patients
receive up to 8 polifeprosan 20 wafers containing increasing doses of carmustine implanted
into the resection cavity.
Patients with an intraoperative diagnosis other than glioblastoma multiforme or anaplastic
astrocytoma do not receive wafer implantation, and are removed from study.
Patients are followed 3, 6, and 12 months after implantation.
PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study.
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|
|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|