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	Treatment or Intervention	Phase
Recurrent Melanoma stage 0 melanoma stage I melanoma stage II melanoma stage III melanoma Stage IV Melanoma	Procedure: boron neutron capture therapy  Procedure: radiation therapy	Phase II

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Massachusetts
      Beth Israel Deaconess Medical Center, Boston,  Massachusetts,  02215,  United States; Recruiting
      Massachusetts Institute of Technology, Cambridge,  Massachusetts,  02139,  United States; Recruiting

Study chairs or principal investigators

Paul Martin Busse, MD, PhD,  Study Chair,  Beth Israel Deaconess Medical Center   

Study ID Numbers:  CDR0000287207; BIDMC-W-01-0380-FB; BIDMC-2001-P-001946; NCT00059800
Record last reviewed:  April 2003
Last Updated:  December 6, 2004
Record first received:  May 6, 2003
ClinicalTrials.gov Identifier:  NCT00059800
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08