Boron Neutron Capture Therapy in Treating Patients With Melanoma
- Conditions
- Melanoma (Skin)
- Registration Number
- NCT00059800
- Lead Sponsor
- Beth Israel Deaconess Medical Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical response Time course, uniformity, and severity of acute dermal reactions Late dermal reaction after at least six months Pharmacokinetics
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Massachusetts Institute of Technology
🇺🇸Cambridge, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States