Boron Neutron Capture Therapy in Treating Patients With Stage III Melanoma

Phase 1

• Conditions: Melanoma (Skin)

• Registration Number: NCT00002781
• Lead Sponsor: Beth Israel Deaconess Medical Center

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 1996-04
• Study First Submitted: 1999-11-01
• Status Verified: 2000-04
• Study First Submitted QC: 2004-09-01
• Study First Posted: 2004-09-02
• Last Update Submitted: 2013-09-16
• Last Update Posted: 2013-09-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (2)

Boston University School of Medicine; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States