NCT00059800

Boron Neutron Capture Therapy in Treating Patients With Melanoma

A Phase II Trial For Neutron Capture Therapy In Melanoma

• Status: Completed
• Phase: 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: Boron neutron capture therapy may selectively kill tumor cells without harming normal tissue. PURPOSE: Phase II trial to study the effectiveness of boron neutron capture therapy in treating patients who have melanoma.

Detailed description

OBJECTIVES: * Determine the clinical response, by serial objective measurements, in patients with melanoma treated with boron neutron capture therapy. * Determine the time course, uniformity, and severity of acute dermal reactions in patients treated with this regimen. * Determine the late dermal reactions in patients who are followed for at least 6 months after treatment with this regimen. * Determine the pharmacokinetics of this regimen in these patients. OUTLINE: Patients are stratified according to tumor size (no greater than 15 cc vs greater than 15 cc). Patients undergo boron neutron capture therapy. Patients are followed for 3 years. PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 3 years.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
RADIATION	boron neutron capture therapy

Timeline

• Start date: 2002-05-01
• Completion: 2004-01-01
• First posted: 2003-05-07
• Last updated: 2013-06-26

Locations

2 sites across 1 country: United States