Metastatic Cancer Clinical Trial
Official title:
A Phase I/II Trial For Neutron Capture Therapy In Glioblastoma Multiforme And Intracranial Melanoma
RATIONALE: Radiation therapy such as boron neutron capture therapy may kill tumor cells
without harming normal tissue.
PURPOSE: Phase I/II trial to study the effectiveness of boron neutron capture therapy in
treating patients who have glioblastoma multiforme or melanoma metastatic to the brain.
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.
;
Primary Purpose: Treatment
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