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Phase II Study of Boron Neutron Capture Therapy in Patients With Melanoma

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Boron Neutron Capture Therapy in Treating Patients With Melanoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase II Treatment Closed 18 and over Other BIDMC-W-01-0380-FB
BIDMC-2001-P-001946, NCT00059800

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.

Entry 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

Prior/Concurrent Therapy:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

No prior radiotherapy to study sites

Surgery

Not specified

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

Expected Enrollment

A total of 36 patients will be accrued for this study within 3 years.

Outcomes

Primary Outcome(s)

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

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.

Trial Contact Information

Trial Lead Organizations

Beth Israel Deaconess Medical Center

Paul Busse, MD, PhD, Protocol chair
Ph: 617-667-2345

Registry Information

Official Title		A Phase II Trial For Neutron Capture Therapy In Melanoma

Trial Start Date		2002-05-30

Registered in ClinicalTrials.gov		NCT00059800

Date Submitted to PDQ		2003-02-14

Information Last Verified		2005-12-08

NCI Grant/Contract Number		R01-CA90713

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.