SB-715992 in Treating Patients With Metastatic or Recurrent Malignant Melanoma

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed malignant melanoma
• * Previously untreated metastatic or recurrent disease
• * Considered incurable by standard therapies
• Measurable disease
• * At least one unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
• * Bone metastases are not considered measurable disease
• * Outside any previously irradiated area
• * Patients whose sole site of measurable disease is in a previously irradiated area are ineligible unless there is evidence of progression or new lesions documented in the irradiated field
• No known CNS metastases
• * CT scans or MRI are not required to rule out CNS metastases unless patient exhibits neurological signs or symptoms
• * Patients with a prior solitary brain metastasis surgically resected with no evidence of residual disease are eligible provided CT scan or MRI confirms no evidence of disease within the past 28 days
• Archival paraffin tumor specimen available
• PATIENT CHARACTERISTICS:
• Age
• 18 and over
• Performance status
• ECOG 0-2
• Life expectancy
• At least 12 weeks
• Hematopoietic
• Absolute granulocyte count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Hepatic
• Bilirubin normal
• AST and ALT ≤ 2.5 times upper limit of normal (ULN)
• Renal
• Creatinine ≤ 1.5 times ULN
• 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
• No other malignancy except adequately treated nonmelanoma skin cancer, curatively treated carcinoma in situ of the cervix, or other curatively treated solid tumors with no evidence of disease for ≥ 5 years
• No other uncontrolled illness
• No ongoing or active infection
• No psychiatric illness or social situation that would preclude study participation
• No history of allergic reactions attributed to compounds of similar chemical or biological composition to SB-715992
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• At least 3 months since prior adjuvant immunotherapy
• No prior immunotherapy for metastatic or recurrent disease
• Chemotherapy
• No prior chemotherapy, including regional therapy
• Endocrine therapy
• Not specified
• Radiotherapy
• See Disease Characteristics
• At least 4 weeks since prior radiotherapy except for low-dose, non-myelosuppressive radiotherapy
• Surgery
• See Disease Characteristics
• At least 4 weeks since prior major surgery
• Other
• More than 28 days since prior investigational agents
• More than 14 days since prior and no concurrent use of any of the following CYP3A4 inhibitors or inducers:
• * Clarithromycin
• * Erythromycin
• * Troleandomycin
• * Itraconazole
• * Ketoconazole
• * Fluconazole (≤ 200 mg/day allowed)
• * Voriconazole
• * Nefazodone
• * Fluvoxamine
• * Verapamil
• * Diltiazem
• * Grapefruit juice
• * Bitter orange
• * Phenytoin
• * Carbamazepine
• * Phenobarbital
• * Oxcarbazepine
• * Rifampin
• * Rifabutin
• * Rifapentine
• * Hypericum perforatum (St. John's wort)
• * Modafinil
• At least 6 months since prior and no concurrent amiodarone
• No concurrent antiretroviral therapy for HIV-positive patients
• No other concurrent anticancer treatment
• No other concurrent investigational therapies