Boron Neutron Capture Therapy in Treating Patients With Glioblastoma Multiforme or Melanoma Metastatic to the Brain
Description
OBJECTIVES:
Determine the time course, uniformity, and severity of acute and chronic normal tissue reactions in patients with glioblastoma multiforme or intracranial melanoma treated with boronophenylalanine-fructose complex (BPA-f) followed by cranial neutron irradiation using a new fission converter beam facility.
Determine the maximum tolerated dose of cranial neutron capture therapy in these patients.
Determine, through serial objective measurements, the clinical response in patients treated with this therapy.
Determine the pharmacokinetics of BPA-f in these patients.
OUTLINE: This is a dose-escalation study of cranial neutron capture therapy (NCT).
Patients receive boronophenylalanine-fructose complex IV over 90 minutes followed by cranial NCT on days 1 and 2.
Cohorts of 3-6 patients receive escalating doses of NCT until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at the MTD.
Patients are followed at 1, 2, 4, 6, 9, and 12 months and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 16 patients will be accrued for this study within 2 years.
