Boron Neutron Capture Therapy in Treating Patients With Melanoma
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.
|Study Design:||Allocation: Non-Randomized
Primary Purpose: Treatment
|Official Title:||A Phase II Trial For Neutron Capture Therapy In Melanoma|
- Clinical response
- Time course, uniformity, and severity of acute dermal reactions
- Late dermal reaction after at least six months
|Study Start Date:||May 2002|
|Study Completion Date:||January 2004|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00059800
|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|