Melanoma (Skin)
Conditions
Keywords
recurrent melanoma, stage 0 melanoma, stage I melanoma, stage II melanoma, stage III melanoma, stage IV 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.
Interventions
RADIATIONboron neutron capture therapy
Sponsors
Beth Israel Deaconess Medical Center
Study design
Allocation
NON_RANDOMIZED
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Late dermal reaction after at least six months | — |
| Pharmacokinetics | — |
| Clinical response | — |
| Time course, uniformity, and severity of acute dermal reactions | — |
Countries
United States
Outcome results
None listed