Boron Neutron Capture Therapy in Treating Patients With Melanoma
|ClinicalTrials.gov Identifier: NCT00059800|
Recruitment Status : Completed
First Posted : May 7, 2003
Last Update Posted : June 26, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Radiation: boron neutron capture therapy||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase II Trial For Neutron Capture Therapy In Melanoma|
|Study Start Date :||May 2002|
|Actual Study Completion Date :||January 2004|
- Clinical response
- Time course, uniformity, and severity of acute dermal reactions
- Late dermal reaction after at least six months
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|