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.
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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
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
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