Phase I Brachytherapy Dose Escalating Study Using the Proxima Therapeutics, Inc. GliaSite RTS in Patients With Recurrent Malignant Gliomas
- 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
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.
Primary Purpose: Treatment
Larry Kleinberg, MD
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|
|Massachusetts General Hospital Cancer Center||Boston, Massachusetts 02114|
|University of Alabama at Birmingham Comprehensive Cancer Center||Birmingham, Alabama 35294-3300|
|Comprehensive Cancer Center at Wake Forest University||Winston-Salem, North Carolina 27157-1082|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|Cleveland Clinic Taussig Cancer Center||Cleveland, Ohio 44195|
|Josephine Ford Cancer Center at Henry Ford Hospital||Detroit, Michigan 48202|
|Winship Cancer Institute of Emory University||Atlanta, Georgia 30322|
|Abramson Cancer Center at University of Pennsylvania Medical Center||Philadelphia, Pennsylvania 19104|