Boron Neutron Capture Therapy in Treating Patients With Glioblastoma Multiforme or Melanoma Metastatic to the Brain
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|ClinicalTrials.gov Identifier: NCT00039572|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 26, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors Melanoma (Skin) Metastatic Cancer||Drug: boronophenylalanine-fructose complex||Phase 1 Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|