Radiation Therapy in Treating Patients With Progressive or Recurrent Malignant Brain Tumors
- Conditions
- Brain and Central Nervous System Tumors
- Registration Number
- NCT00003574
- Lead Sponsor
- New Approaches to Brain Tumor Therapy Consortium
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
University of Alabama Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
Emory University Hospital - Atlanta
🇺🇸Atlanta, Georgia, United States
Johns Hopkins Oncology Center
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
University of Alabama Comprehensive Cancer Center🇺🇸Birmingham, Alabama, United States