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

Inclusion Criteria

• •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