Boron Neutron Capture Therapy in Treating Patients With Melanoma

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00059800
First received: May 6, 2003
Last updated: June 25, 2013
Last verified: December 2005
  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 [ Designated as safety issue: No ]
  • Time course, uniformity, and severity of acute dermal reactions [ Designated as safety issue: No ]
  • Late dermal reaction after at least six months [ Designated as safety issue: No ]
  • Pharmacokinetics [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00059800     History of Changes
Other Study ID Numbers: BIDMC-W-01-0380-FB, CDR0000287207, BIDMC-2001-P-001946
Study First Received: May 6, 2003
Last Updated: June 25, 2013
Health Authority: United States: Federal Government

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014