Brain and Central Nervous System Tumors Clinical Trial
Official title:
Phase I Brachytherapy Dose Escalating Study Using the Proxima Therapeutics, Inc. GliaSite RTS in Patients With Recurrent Malignant Gliomas
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.
;
Primary Purpose: Treatment
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