Boron Neutron Capture Therapy in Treating Patients With Melanoma

NCT ID: NCT00059800

Last Updated: 2013-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-05-31
• Study Completion Date: 2004-01-31

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.

Conditions

Melanoma (Skin)

Study Design

• Allocation Method: NON_RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

boron neutron capture therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Principal Investigators

Paul M. Busse, MD, PhD

Role: STUDY_CHAIR

Beth Israel Deaconess Medical Center

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Massachusetts Institute of Technology

Cambridge, Massachusetts, United States

Countries

United States

Other Identifiers

CDR0000287207

Identifier Type: REGISTRY

Identifier Source: secondary_id

BIDMC-2001-P-001946

Identifier Type: -

Identifier Source: secondary_id

BIDMC-W-01-0380-FB

Identifier Type: -

Identifier Source: org_study_id