sb-715992 in treating patients with metastatic or recurrent malignant melanoma

Conditions: Melanoma (Skin)

Summary: rationale: drugs used in chemotherapy, such as sb-715992, work in different ways to stop tumor cells from dividing so they stop growing or die. purpose: this phase ii trial is studying how well sb-715992 works in treating patients with metastatic or recurrent malignant melanoma.

objectives: * determine the efficacy of sb-715992, in terms of response rate, in patients with previously untreated metastatic or recurrent malignant melanoma. * determine the toxic effects of this drug in these patients. * determine the early progression rate and response duration in patients treated with this drug. * determine the pharmacokinetics of this drug in these patients. * correlate pharmacokinetics with safety and efficacy endpoints of this drug in these patients. * correlate β-tubulin and kinesin spindle protein expression in tumor tissue with clinical outcomes in patients treated with this drug. outline: this is a nonrandomized, multicenter study. patients receive sb-715992 iv over 1 hour on day 1. courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. all patients are followed at 4 weeks after completion of protocol therapy. patients with ongoing complete response, partial response, or stable disease are followed every 3 months thereafter until relapse. projected accrual: a total of 15-25 patients will be accrued for this study within 12-14 months.

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

Keywords: recurrent melanoma stage iv melanoma