Boron Neutron Capture Therapy in Treating Patients With Melanoma

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. Identifier: NCT00059800
Recruitment Status : Completed
First Posted : May 7, 2003
Last Update Posted : June 26, 2013
Information provided by:
National Cancer Institute (NCI)

May 6, 2003
May 7, 2003
June 26, 2013
May 2002
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  • Clinical response
  • Time course, uniformity, and severity of acute dermal reactions
  • Late dermal reaction after at least six months
  • Pharmacokinetics
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Complete list of historical versions of study NCT00059800 on Archive Site
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Boron Neutron Capture Therapy in Treating Patients With Melanoma
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.


  • 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.

Phase 2
Allocation: Non-Randomized
Primary Purpose: Treatment
Melanoma (Skin)
Radiation: boron neutron capture therapy
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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January 2004
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  • 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



  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • More than 6 months


  • Not specified


  • Not specified


  • Creatinine normal


  • 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


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


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • Not specified


  • No prior radiotherapy to study sites


  • Not specified
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
CDR0000287207 ( Registry Identifier: PDQ (Physician Data Query) )
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Beth Israel Deaconess Medical Center
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Study Chair: Paul M. Busse, MD, PhD Beth Israel Deaconess Medical Center
National Cancer Institute (NCI)
December 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP