Brachytherapy in Treating Patients With Recurrent Malignant Glioma
- Conditions
- Brain and Central Nervous System Tumors
- Registration Number
- NCT00045474
- Lead Sponsor
- National Cancer Institute (NCI)
- Brief Summary
RATIONALE: Brachytherapy uses radioactive material to kill cancer cells remaining after surgery.
PURPOSE: Phase I trial to study the effectiveness of brachytherapy in treating patients who have recurrent malignant glioma.
- Detailed Description
OBJECTIVES:
* Determine the maximum tolerated dose of brachytherapy using an intracavitary applicator and liquid iodine I 125 in patients with recurrent malignant glioma.
* Determine the acute and chronic toxicity of this therapy in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
Within 3-21 days after surgical resection, patients receive brachytherapy using an intracavity balloon application (GliaSite) with iodine I 125 solution for a total of 5-7 days.
Cohorts of 5-10 patients receive escalating doses of brachytherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 10 patients experience dose-limiting toxicity.
Patients are followed at 4 weeks and then every 2 months for 1 year.
PROJECTED ACCRUAL: Approximately 20-30 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 at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
Winship Cancer Institute of Emory University
🇺🇸Atlanta, Georgia, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States
Josephine Ford Cancer Center at Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Abramson Cancer Center at University of Pennsylvania Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
University of Alabama at Birmingham Comprehensive Cancer Center🇺🇸Birmingham, Alabama, United States