Boron Neutron Capture Therapy in Treating Patients With Melanoma
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|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|
|Study Completion Date :||January 2004|
- Clinical response
- Time course, uniformity, and severity of acute dermal reactions
- Late dermal reaction after at least six months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|