Boron Neutron Capture Therapy in Treating Patients With Melanoma - Tabular View

Tracking Information

First Received Date ^ICMJE

May 6, 2003

Last Updated Date

February 6, 2009

Start Date ^ICMJE

May 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00059800 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Boron Neutron Capture Therapy in Treating Patients With Melanoma

Official Title ^ICMJE

A Phase II Trial For Neutron Capture Therapy In Melanoma

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Active Control

Condition ^ICMJE

Melanoma (Skin)

Intervention ^ICMJE

Radiation: boron neutron capture therapy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00059800

Responsible Party

Study ID Numbers ^ICMJE

CDR0000287207, BIDMC-W-01-0380-FB, BIDMC-2001-P-001946

Study Sponsor ^ICMJE

Beth Israel Deaconess Medical Center

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Paul M. Busse, MD, PhD

Beth Israel Deaconess Medical Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

December 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP