Boron Neutron Capture Therapy in Treating Patients With Stage III Melanoma
NCT ID: NCT00002781
Last Updated: 2013-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
15 participants
INTERVENTIONAL
1996-04-30
Brief Summary
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PURPOSE: Phase I trial to study the effectiveness of boron neuron capture therapy in treating patients with stage III melanoma.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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boronophenylalanine-fructose complex
Eligibility Criteria
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Inclusion Criteria
PRIOR CONCURRENT THERAPY: No prior radiotherapy to the target area
18 Years
ALL
No
Sponsors
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Beth Israel Deaconess Medical Center
OTHER
Principal Investigators
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Paul M. Busse, MD, PhD
Role: STUDY_CHAIR
Beth Israel Deaconess Medical Center
Locations
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Boston University School of Medicine
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Countries
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Other Identifiers
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NEDH-961207015
Identifier Type: -
Identifier Source: secondary_id
NCI-V96-0907
Identifier Type: -
Identifier Source: secondary_id
CDR0000064811
Identifier Type: -
Identifier Source: org_study_id