Radiation Therapy in Treating Patients With Progressive or Recurrent Malignant Brain Tumors
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of radiation therapy in treating patients who are undergoing surgical removal of progressive or recurrent malignant brain tumors.
|Brain and Central Nervous System Tumors||Procedure: surgical procedure Radiation: brachytherapy Radiation: intraoperative radiation therapy Radiation: iodine I 125||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||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|
|Study Start Date:||April 1999|
|Study Completion Date:||June 2004|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003574
|United States, Alabama|
|University of Alabama Comprehensive Cancer Center|
|Birmingham, Alabama, United States, 35294|
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|United States, Georgia|
|Emory University Hospital - Atlanta|
|Atlanta, Georgia, United States, 30322|
|United States, Maryland|
|Johns Hopkins Oncology Center|
|Baltimore, Maryland, United States, 21287|
|United States, Massachusetts|
|Massachusetts General Hospital Cancer Center|
|Boston, Massachusetts, United States, 02114|
|United States, Michigan|
|Henry Ford Hospital|
|Detroit, Michigan, United States, 48202|
|United States, North Carolina|
|Comprehensive Cancer Center of Wake Forest University Baptist Medical Center|
|Winston-Salem, North Carolina, United States, 27157-1082|
|United States, Pennsylvania|
|University of Pennsylvania Cancer Center|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Texas|
|University of Texas Health Science Center at San Antonio|
|San Antonio, Texas, United States, 78284-7811|
|Study Chair:||Stephen Tatter, MD, PhD||Wake Forest University Health Sciences|