Boron Neutron Capture Therapy in Treating Patients With Melanoma

June 25, 2013 updated by: Beth Israel Deaconess Medical Center

A Phase II Trial For Neutron Capture Therapy In Melanoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • 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

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Cambridge, Massachusetts, United States, 02139
        • Massachusetts Institute of Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed melanoma
  • Evaluable disease

  • Lesion(s) to be irradiated must be located in 1 of the following areas:

    • On an extremity
    • On the head or neck (including the scalp)
    • In the subdermal lymphatics (excluding the proximal axilla)

  • Area to be irradiated must not exceed a maximum dimension of 10 cm

    • Maximum tumor depth from the surface of the skin cannot exceed 6 cm

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • More than 6 months

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Creatinine normal

Cardiovascular

  • No history of severe cardiac disease
  • No uncontrolled arrhythmias or conduction defects
  • No unstable or newly diagnosed angina pectoris
  • No recent coronary artery disease
  • No congestive heart failure

Other

  • Not pregnant
  • Negative pregnancy test
  • No history of phenylketonuria
  • Must have sufficient mental competence

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy to study sites

Surgery

  • Not specified

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pharmacokinetics
Clinical response
Time course, uniformity, and severity of acute dermal reactions
Late dermal reaction after at least six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2002

Study Completion (Actual)

January 1, 2004

Study Registration Dates

First Submitted

May 6, 2003

First Submitted That Met QC Criteria

May 6, 2003

First Posted (Estimate)

May 7, 2003

Study Record Updates

Last Update Posted (Estimate)

June 26, 2013

Last Update Submitted That Met QC Criteria

June 25, 2013

Last Verified

December 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIDMC-W-01-0380-FB
  • CDR0000287207 (Registry Identifier: PDQ (Physician Data Query))
  • BIDMC-2001-P-001946

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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