Boron Neutron Capture Therapy in Treating Patients With Melanoma

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Melanoma (Skin)

Intervention / Treatment
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* Radiation: boron neutron capture therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: boron neutron capture therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response |  |  | 
| Time course, uniformity, and severity of acute dermal reactions |  |  | 
| Late dermal reaction after at least six months |  |  | 
| Pharmacokinetics |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent melanoma, stage 0 melanoma, stage I melanoma, stage II melanoma, stage III melanoma, stage IV melanoma