Trials / Completed
CompletedNCT00039572
Boron Neutron Capture Therapy in Treating Patients With Glioblastoma Multiforme or Melanoma Metastatic to the Brain
A Phase I/II Trial For Neutron Capture Therapy In Glioblastoma Multiforme And Intracranial Melanoma
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Beth Israel Deaconess Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | boronophenylalanine-fructose complex |
Timeline
- Start date
- 2002-05-01
- Completion
- 2005-01-01
- First posted
- 2003-01-27
- Last updated
- 2013-06-26
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00039572. Inclusion in this directory is not an endorsement.