Boron Neutron Capture Therapy in Treating Patients With Glioblastoma Multiforme or Melanoma Metastatic to the Brain
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.
|Brain and Central Nervous System Tumors Melanoma (Skin) Metastatic Cancer||Drug: boronophenylalanine-fructose complex||Phase 1 Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I/II Trial For Neutron Capture Therapy In Glioblastoma Multiforme And Intracranial Melanoma|
|Study Start Date:||May 2002|
|Study Completion Date:||January 2005|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00039572
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Massachusetts Institute of Technology|
|Cambridge, Massachusetts, United States, 02139|
|Study Chair:||Paul M. Busse, MD, PhD||Beth Israel Deaconess Medical Center|