Melanoma Clinical Trial
Boron Neutron Capture Therapy in Treating Patients With Melanoma
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.
Full 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.
Eligibility 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
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There are 2 Locations for this study
Boston Massachusetts, 02215, United States
Cambridge Massachusetts, 02139, United States
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