A Multi-Center, Open-Label Clinical Study to Evaluate the Safety and Performance of the Proxima GliaSite RTS, a Radiation Delivery System, in Patients With Recurrent Malignant Brain Tumors Undergoing Surgical Resection
OBJECTIVES: I. Evaluate the safety of the GliaSite RTS in patients with progressive or
recurrent malignant brain tumors undergoing surgical resection. II. Evaluate the performance
of the GliaSite RTS in these patients.
OUTLINE: This is an open label, multicenter study. Patients undergo surgical resection of
the tumor followed by surgical placement of the GliaSite device in the resection cavity. One
to 2 weeks after surgery, patients receive brachytherapy consisting of an infusion of iodine
I-125. The I-125 solution is removed and collected 5-7 days later. The device is surgically
removed within 24 hours. Patients are followed at 24 hours, 14 days, and 1 year post device
removal.
PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.
Interventional
Primary Purpose: Treatment
Stephen Tatter, MD, PhD
Study Chair
Comprehensive Cancer Center of Wake Forest University
United States: Federal Government
CDR0000066641
NCT00003574
April 1999
June 2004
Name | Location |
---|---|
University of Alabama Comprehensive Cancer Center | Birmingham, Alabama 35294 |
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
Emory University Hospital - Atlanta | Atlanta, Georgia 30322 |
Johns Hopkins Oncology Center | Baltimore, Maryland 21287 |
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | Winston-Salem, North Carolina 27157-1082 |
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 |
Henry Ford Hospital | Detroit, Michigan 48202 |