SB-715992 in Treating Patients With Metastatic or Recurrent Malignant Melanoma
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of SB-715992 (NSC 727990) in Previously Untreated Patients With Metastatic or Recurrent Malignant Melanoma|
- Response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Pharmacokinetics at day 1 of course 1 (day 1 of course 2 if dose is changed) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Molecular correlates on archival tissue, fresh tumor tissue, and peripheral blood mononuclear cells (PVMCs) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||November 2004|
|Study Completion Date:||September 2008|
|Primary Completion Date:||September 2006 (Final data collection date for primary outcome measure)|
- 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.
|Canada, British Columbia|
|British Columbia Cancer Agency - Centre for the Southern Interior|
|Kelowna, British Columbia, Canada, V1Y 5L3|
|Fraser Valley Cancer Centre at British Columbia Cancer Agency|
|Surrey, British Columbia, Canada, V3V 1Z2|
|British Columbia Cancer Agency - Vancouver Cancer Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Canada, Nova Scotia|
|Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre|
|Halifax, Nova Scotia, Canada, B3H 1V7|
|Margaret and Charles Juravinski Cancer Centre|
|Hamilton, Ontario, Canada, L8V 5C2|
|Toronto Sunnybrook Regional Cancer Centre at Sunnybrook and Women's College Health Sciences Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|Centre Hospitalier de l'Universite de Montreal|
|Montreal, Quebec, Canada, H2L-4M1|
|Study Chair:||Christopher Lee, MD||BCCA - Fraser Valley Cancer Centre|