Everolimus in Treating Patients With Stage IV Melanoma

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed malignant melanoma for which no known standard or potentially curative therapy exists or has been proven to extend life expectancy
• •* Stage IV disease
• •Measurable disease
• •* At least 1 lesion ≥ 20 mm by CT scan or MRI OR ≥ 10 mm by spiral CT scan
• •No intracranial disease
• •PATIENT CHARACTERISTICS:
• •Age
• •18 and over
• •Performance status
• •ECOG 0-2
• •Life expectancy
• •At least 12 weeks
• •Hematopoietic
• •Absolute neutrophil count ≥ 1,500/mm\^3
• •Platelet count ≥ 100,000/mm\^3
• •Hemoglobin ≥ 9.0 g/dL
• •No bleeding diathesis
• •Hepatic
• •AST ≤ 3 times upper limit of normal (ULN)
• •Alkaline phosphatase ≤ 3 ULN
• •INR ≤ 1.5
• •Renal
• •Creatinine ≤ 1.5 times ULN
• •Other
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •Willing to refrain from foods high in fat content
• •No uncontrolled infection
• •No immunosuppression from any cause (e.g., known HIV infection)
• •No other malignancy within the past 5 years except basal cell or squamous cell skin cancer treated with local resection only
• •No other severe condition that would preclude study participation or compliance
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy
• •More than 4 weeks since prior immunotherapy or biologic therapy
• •Chemotherapy
• •More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
• •No prior sirolimus or its analogues for any indication
• •No other concurrent chemotherapy
• •Endocrine therapy
• •No concurrent steroids
• •Radiotherapy
• •More than 4 weeks since prior radiotherapy to head and neck area
• •More than 4 weeks since prior radiosurgery
• •No prior radiotherapy to \> 30% of bone marrow
• •No concurrent radiotherapy
• •Surgery
• •Not specified
• •Other
• •At least 1 week since prior and no concurrent CYP3A4 inducers
• •No concurrent warfarin
• •No concurrent cytotoxic agents
• •No other concurrent experimental drugs
• •No other concurrent immunosuppressive therapy