Spots Global Cancer Trial Database for SB-715992 in Treating Patients With Metastatic or Recurrent Malignant Melanoma
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Trial Identification
Brief Title: SB-715992 in Treating Patients With Metastatic or Recurrent Malignant Melanoma
Official Title: A Phase II Study of SB-715992 (NSC 727990) in Previously Untreated Patients With Metastatic or Recurrent Malignant Melanoma
Study ID: NCT00095953
Conditions
Interventions
Study Description
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
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
Contact Details
Name: Christopher Lee, MD
Affiliation: BCCA - Fraser Valley Cancer Centre
Role: STUDY_CHAIR
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