RATIONALE: Boron neutron capture therapy may selectively kill tumor cells without harming normal tissue. PURPOSE: This phase I trial is studying the side effects and best dose of boron neutron capture therapy following surgery in treating patients with glioblastoma multiforme removed during surgery.
OBJECTIVES: * Determine systemic and local toxicity of borocaptate sodium with boron neutron capture therapy (BNCT) following craniotomy with gross total resection in patients with glioblastoma multiforme. * Determine the qualitative and quantitative dose-limiting toxicity and maximum tolerated dose of this regimen in these patients. * Determine the maximum tolerated radiation dose of BNCT in cranial localization to healthy tissues in these patients under defined conditions. OUTLINE: This is a dose escalation, multicenter study. Within 6 weeks of surgery, patients receive borocaptate sodium followed 12-18 hours later by neutron irradiation. Treatment repeats daily for 4 days. Cohorts of 3-9 patients receive escalating doses of neutron irradiation. The maximum tolerated dose is defined as the dose preceding that at which 3 or more patients experience dose limiting toxicity. Patients are followed weekly for 4 weeks, monthly for 2 months, every 6 weeks for 15 months and then every 3 months thereafter. PROJECTED ACCRUAL: Approximately 30-36 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Enrollment
36
Karl-Franzens-University Graz
Graz, Austria
Toronto Sunnybrook Regional Cancer Centre at Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Hopital Pasteur
Nice, France
Universitaetsklinikum Essen
Essen, Germany
Acute toxicity as measured by NCIC-Common Toxicity Criteria up to 30 days after the first BSH administration
Late toxicity as measured by RTOC and EORTC late radiation morbidity scale from 90 days after completion of irradiation treatment until death
Overall survival as measured by Logrank until death
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Klinikum der Universitaet Muenchen - Grosshadern Campus
Munich, Germany
Ospedale Santa Chiara Pisa
Pisa, Italy
Vrije Universiteit Medisch Centrum
Amsterdam, Netherlands
EC Joint Research Centre - Institute for Energy
Petten, Netherlands