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Boron Neutron Capture Therapy in Treating Patients With Stage III Melanoma

Sponsor
Beth Israel Deaconess Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT00002781
Collaborator
(none)
15
Enrollment
2
Locations
7.5
Patients Per Site

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: boronophenylalanine-fructose complex
 Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Primary Purpose:
Treatment
Official Title:
PROCEDURES FOR BNCT PHASE-I STUDY OF MELANOMA IN THE EXTREMITIES
Study Start Date :
Apr 1, 1996

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    DISEASE CHARACTERISTICS: Biopsy-proven melanoma that is clinical stage III Estimated clinical tumor depth 1.0-6.0 cm from the epidermis Tumor surface diameter no greater than 10 cm Grossly evident cutaneous or subcutaneous tumor nodules are eligible for irradiation

    PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70%-100% Life expectancy: More than 3 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No history of phenylketonuria Negative serum pregnancy test required of fertile women Adequate contraception required of fertile women during and for 6 months after the study

    PRIOR CONCURRENT THERAPY: No prior radiotherapy to the target area

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Boston University School of Medicine Boston Massachusetts United States 02118
    2 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215

    Sponsors and Collaborators

    • Beth Israel Deaconess Medical Center

    Investigators

    • Study Chair: Paul M. Busse, MD, PhD, Beth Israel Deaconess Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00002781
    Other Study ID Numbers:
    • CDR0000064811
    • NEDH-961207015
    • NCI-V96-0907
    First Posted:
    Sep 2, 2004
    Last Update Posted:
    Sep 17, 2013
    Last Verified:
    Apr 1, 2000
    Keywords provided by , ,
    stage III melanoma
    recurrent melanoma
    Additional relevant MeSH terms:
    Melanoma

    Study Results

    No Results Posted as of Sep 17, 2013