Boron Neutron Capture Therapy in Treating Patients With Stage III Melanoma
|ClinicalTrials.gov Identifier: NCT00002781|
Recruitment Status : Unknown
Verified April 2000 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : September 2, 2004
Last Update Posted : September 17, 2013
RATIONALE: Boron neutron capture therapy may selectively kill tumor cells without harming normal tissue.
PURPOSE: Phase I trial to study the effectiveness of boron neuron capture therapy in treating patients with stage III melanoma.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Drug: boronophenylalanine-fructose complex||Phase 1|
OBJECTIVES: I. Estimate the maximum tolerated dose of neutron irradiation that can be given in combination with borophenylalanine-fructose complex (BPA-F) in patients with stage III melanoma. II. Evaluate the safety of this regimen. III. Evaluate tumor response to this regimen.
OUTLINE: This is a dose-finding study. Patients receive a test dose of borophenylalanine-fructose complex (BPA-F) for biodistribution studies and undergo punch biopses of tumor and normal tissue to measure B-10 concentration. Later, a treatment dose of BPA-F over 1 hour is followed by neutron irradiation. Groups of 3 patients receive escalated doses of neutron irradiation until the maximum tolerated dose is determined. Patients who complete protocol treatment and continue to meet the eligibility criteria may re-enter the study, provided at least 6 months has elapsed since the completion of prior therapy and the field boundary for the new irradiation site is seperated from the boundary of the previously irradiated site. Patients are followed monthly for 12 months, then every 3-6 months as needed.
PROJECTED ACCRUAL: Approximately 15 patients will be entered.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Official Title:||PROCEDURES FOR BNCT PHASE-I STUDY OF MELANOMA IN THE EXTREMITIES|
|Study Start Date :||April 1996|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002781
|United States, Massachusetts|
|Boston University School of Medicine|
|Boston, Massachusetts, United States, 02118|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Study Chair:||Paul M. Busse, MD, PhD||Beth Israel Deaconess Medical Center|