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

About this trial
This is an interventional treatment trial for Melanoma (Skin) focused on measuring recurrent melanoma, stage IV melanoma
Eligibility 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
Sites / Locations
- British Columbia Cancer Agency - Centre for the Southern Interior
- Fraser Valley Cancer Centre at British Columbia Cancer Agency
- British Columbia Cancer Agency - Vancouver Cancer Centre
- Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre
- Margaret and Charles Juravinski Cancer Centre
- Toronto Sunnybrook Regional Cancer Centre at Sunnybrook and Women's College Health Sciences Centre
- Centre Hospitalier de l'Universite de Montreal