Boron Neutron Capture Therapy in Treating Patients With Glioblastoma Multiforme or Melanoma Metastatic to the Brain

Phase 1

Completed

• Conditions: Melanoma (Skin); Brain and Central Nervous System Tumors; Metastatic Cancer

• Registration Number: NCT00039572
• Lead Sponsor: Beth Israel Deaconess Medical Center

Brief 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.

Study Timeline

• Study Start: 2002-05
• Study First Submitted: 2002-06-06
• Status Verified: 2002-07
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Study Completion: 2005-01
• Last Update Submitted: 2013-06-25
• Last Update Posted: 2013-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (2)

Massachusetts Institute of Technology; 🇺🇸 Cambridge, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States