CCI-779 in Treating Patients With Metastatic Melanoma

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