Phase I Brachytherapy Dose Escalation Using The GliaSite RTS In Newly Diagnosed Glioblastoma Multiforme In Conjunction With External Beam Radiation Therapy

Brief Summary

Detailed Description

OBJECTIVES: * Determine the maximum tolerated dose of brachytherapy administered via GliaSite RTS™ applicator followed by external beam radiotherapy in patients with newly diagnosed glioblastoma multiforme. * Determine the acute and chronic toxicity of brachytherapy administered via GliaSite RTS™ in these patients. * Determine the survival rate of patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of brachytherapy. Patients undergo craniotomy for histologic confirmation of glioblastoma multiforme, surgical resection, and placement of a GliaSite RTS™ applicator that includes Iotrex™. Beginning 3-21 days after surgery, patients undergo brachytherapy via the GliaSite RTS™ applicator. Within 30 days of brachytherapy (no more than 60 days after resection) patients undergo external beam radiotherapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity. 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 5 or 3 of 10 patients experience dose-limiting toxicity. Patients are followed at 21-35 days, every 2 months for 1 year, and then for survival. PROJECTED ACCRUAL: A total of 15-100 patients will be accrued for this study.

Primary Outcomes

Not specified