Brain and Central Nervous System Tumors Clinical Trial
Official title:
Postoperative Treatment of Glioblastoma With BNCT at the Petten Irradiation Facility
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.
;
Primary Purpose: Treatment
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