CCI-779 in Treating Patients With Metastatic Melanoma

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically or cytologically confirmed metastatic melanoma that is incurable by surgery, radiotherapy, or limb perfusion
• Measurable disease
• * At least 20 mm by conventional techniques OR
• * At least 10 mm by spiral CT scan
• * The following are not considered measurable:
• * Bone lesions
• * Leptomeningeal disease
• * Ascites
• * Pleural/pericardial effusion
• * Inflammatory breast disease
• * Lymphangitis cutis/pulmonis
• * Abdominal masses not confirmed and followed by imaging techniques
• * Cystic lesions
• Progressive disease
• No prior or concurrent CNS metastasis
• PATIENT CHARACTERISTICS:
• Age:
• 18 and over
• Performance status:
• ECOG 0-2
• Life expectancy:
• More than 4 months
• Hematopoietic:
• WBC at least 3,000/mm\^3
• Absolute neutrophil count at least 1,500/mm\^3
• Platelet count at least 100,000/mm\^3
• Hepatic:
• Bilirubin normal
• AST and ALT no greater than 2.5 times upper limit of normal
• Cholesterol no greater than 350 mg/dL (lipid-lowering therapy allowed)
• Triglycerides no greater than 300 mg/dL except for hydroxymethyl-glutaryl-coenzyme A reductase inhibitors
• Renal:
• Creatinine normal OR
• Creatinine clearance at least 60 mL/min
• Cardiovascular:
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia
• Other:
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• HIV negative
• No prior allergic reactions to compounds of similar chemical or biological composition to study drug
• No ongoing or active infection
• No seizure disorder
• No autoimmune disease
• No psychiatric illness or social situation that would preclude study
• No other concurrent uncontrolled illness that would preclude study
• PRIOR CONCURRENT THERAPY:
• Biologic therapy:
• No more than 1 prior adjuvant biological therapy regimen
• No more than 1 prior biological therapy regimen for advanced disease
• At least 6 months since prior biological therapy or biochemotherapy and recovered
• Prior isolated limb perfusion with biological agent allowed if not to sole site of disease
• Chemotherapy:
• See Biologic therapy
• Prior isolated limb perfusion with chemotherapy allowed if not to sole site of disease
• No more than 1 prior chemotherapy-containing regimen for advanced disease, regardless of adjuvant therapy
• * May be in addition to 1 prior biologic regimen for advanced disease OR
• * May have had 1 prior biochemotherapy regimen for advanced disease
• At least 3 weeks since prior chemotherapy and recovered
• Endocrine therapy:
• At least 1 week since prior dexamethasone
• No concurrent glucocorticosteroid therapy
• Radiotherapy:
• See Disease Characteristics
• Surgery:
• See Disease Characteristics
• Other:
• At least 1 week since prior phenobarbital, phenytoin, carbamazepine, or rifampin
• At least 3 weeks since other prior agents to treat malignancy
• At least 3 weeks since prior investigational agents
• No other concurrent investigational agents
• No concurrent drugs that are metabolized by or alter the level of cytochrome P450-3A