Boron Neutron Capture Therapy in Treating Patients With Melanoma

Sponsor

Beth Israel Deaconess Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00059800

Collaborator

(none)

Locations

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Melanoma (Skin)	Radiation: boron neutron capture therapy	Phase 2

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 Design

Study Type:

Interventional

Allocation:

Non-Randomized

Primary Purpose:

Treatment

Official Title:

A Phase II Trial For Neutron Capture Therapy In Melanoma

Study Start Date :

May 1, 2002

Actual Study Completion Date :

Jan 1, 2004

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
2	Massachusetts Institute of Technology	Cambridge	Massachusetts	United States	02139