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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)
May 6, 2003
May 7, 2003
June 26, 2013
May 2002
Not Provided
  • Clinical response
  • Time course, uniformity, and severity of acute dermal reactions
  • Late dermal reaction after at least six months
  • Pharmacokinetics
Not Provided
Complete list of historical versions of study NCT00059800 on ClinicalTrials.gov 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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Primary Purpose: Treatment
Melanoma (Skin)
Radiation: boron neutron capture therapy
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
January 2004
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00059800
BIDMC-W-01-0380-FB
CDR0000287207 ( Registry Identifier: PDQ (Physician Data Query) )
BIDMC-2001-P-001946
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Beth Israel Deaconess Medical Center
Not Provided
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