A Phase I/II Trial For Neutron Capture Therapy In Glioblastoma Multiforme And Intracranial Melanoma
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:
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.
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
No prior severe cardiac disease, including the following:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery: