SB-715992 in Treating Patients With Metastatic or Recurrent Malignant Melanoma
- Conditions
- Melanoma (Skin)
- Registration Number
- NCT00095953
- Lead Sponsor
- NCIC Clinical Trials Group
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Response 2 years
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (7)
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
British Columbia Cancer Agency - Centre for the Southern Interior🇨🇦Kelowna, British Columbia, Canada