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Boron Neutron Capture Therapy in Treating Patients With Melanoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00059800
First Posted: May 7, 2003
Last Update Posted: June 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  Purpose

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.


Condition Intervention Phase
Melanoma (Skin) Radiation: boron neutron capture therapy Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Primary Purpose: Treatment
Official Title: A Phase II Trial For Neutron Capture Therapy In Melanoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

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

Study Start Date: May 2002
Study Completion Date: January 2004
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00059800


Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Massachusetts Institute of Technology
Cambridge, Massachusetts, United States, 02139
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Study Chair: Paul M. Busse, MD, PhD Beth Israel Deaconess Medical Center
  More Information

ClinicalTrials.gov Identifier: NCT00059800     History of Changes
Other Study ID Numbers: BIDMC-W-01-0380-FB
CDR0000287207 ( Registry Identifier: PDQ (Physician Data Query) )
BIDMC-2001-P-001946
First Submitted: May 6, 2003
First Posted: May 7, 2003
Last Update Posted: June 26, 2013
Last Verified: December 2005

Keywords provided by National Cancer Institute (NCI):
recurrent melanoma
stage 0 melanoma
stage I melanoma
stage II melanoma
stage III melanoma
stage IV melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Boron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs