CCI-779 in Treating Patients With Metastatic Melanoma

Inclusion Criteria

• •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