Spots Global Cancer Trial Database for Boron Neutron Capture Therapy in Treating Patients With Melanoma

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Trial Identification

Brief Title: Boron Neutron Capture Therapy in Treating Patients With Melanoma

Official Title: A Phase II Trial For Neutron Capture Therapy In Melanoma

Study ID: NCT00059800

Conditions

Melanoma (Skin)

Interventions

boron neutron capture therapy

Study Description

Brief 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.