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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
17
SB-715992 will be given as a 1 hour intravenous infusion in a dose of 18 mg/m2 once every 3 weeks.
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, Canada
Fraser Valley Cancer Centre at British Columbia Cancer Agency
Surrey, British Columbia, Canada
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, Canada
Response
Time frame: 2 years
Toxicity
Time frame: 2 years
Pharmacokinetics at day 1 of course 1 (day 1 of course 2 if dose is changed)
Time frame: 2 years
Molecular correlates on archival tissue, fresh tumor tissue, and peripheral blood mononuclear cells (PVMCs)
Time frame: 2 years
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Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada
Toronto Sunnybrook Regional Cancer Centre at Sunnybrook and Women's College Health Sciences Centre
Toronto, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada