Everolimus in Treating Patients With Stage IV Melanoma

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