Phase II Trial Of RAD-001 In Metastatic Malignant 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