Spots Global Cancer Trial Database for Brachytherapy in Treating Patients With Recurrent Malignant Glioma
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Trial Identification
Brief Title: Brachytherapy in Treating Patients With Recurrent Malignant Glioma
Official Title: Phase I Brachytherapy Dose Escalating Study Using the Proxima Therapeutics, Inc. GliaSite RTS in Patients With Recurrent Malignant Gliomas
Study ID: NCT00045474
Conditions
Study Description
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Contact Details
Name: Larry Kleinberg, MD
Affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Role: STUDY_CHAIR
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