Melanoma (Skin)
Conditions
Keywords
recurrent melanoma, stage IV melanoma
Brief 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.
Detailed description
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.
Interventions
SB-715992 will be given as a 1 hour intravenous infusion in a dose of 18 mg/m2 once every 3 weeks.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity | 2 years |
| Pharmacokinetics at day 1 of course 1 (day 1 of course 2 if dose is changed) | 2 years |
| Molecular correlates on archival tissue, fresh tumor tissue, and peripheral blood mononuclear cells (PVMCs) | 2 years |
Countries
Canada