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Boron Neutron Capture Therapy in Treating Patients With Melanoma

Primary Purpose

Melanoma (Skin)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
boron neutron capture therapy
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring recurrent melanoma, stage 0 melanoma, stage I melanoma, stage II melanoma, stage III melanoma, stage IV melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beth Israel Deaconess Medical Center
  • Massachusetts Institute of Technology

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 6, 2003
Last Updated
June 25, 2013
Sponsor
Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00059800
Brief Title
Boron Neutron Capture Therapy in Treating Patients With Melanoma
Official Title
A Phase II Trial For Neutron Capture Therapy In Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2005
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Beth Israel Deaconess Medical Center

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)
Keywords
recurrent melanoma, stage 0 melanoma, stage I melanoma, stage II melanoma, stage III melanoma, stage IV melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type
Radiation
Intervention Name(s)
boron neutron capture therapy
Primary Outcome Measure Information:
Title
Clinical response
Title
Time course, uniformity, and severity of acute dermal reactions
Title
Late dermal reaction after at least six months
Title
Pharmacokinetics

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul M. Busse, MD, PhD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Massachusetts Institute of Technology
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02139
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Boron Neutron Capture Therapy in Treating Patients With Melanoma

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