A Phase II Study Of CCI-779 (NSC 683864) In 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