SB-715992 in Treating Patients With Metastatic or Recurrent Malignant Melanoma
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|ClinicalTrials.gov Identifier: NCT00095953|
Recruitment Status : Completed
First Posted : November 9, 2004
Last Update Posted : May 17, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Drug: ispinesib||Phase 2|
- 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 (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of SB-715992 (NSC 727990) in Previously Untreated Patients With Metastatic or Recurrent Malignant Melanoma|
|Study Start Date :||November 2004|
|Actual Primary Completion Date :||September 2006|
|Actual Study Completion Date :||September 2008|
- Drug: ispinesib
SB-715992 will be given as a 1 hour intravenous infusion in a dose of 18 mg/m2 once every 3 weeks.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00095953
|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|