NCT00095953

SB-715992 in Treating Patients With Metastatic or Recurrent Malignant Melanoma

A Phase II Study of SB-715992 (NSC 727990) in Previously Untreated Patients With Metastatic or Recurrent Malignant Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: NCIC Clinical Trials Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
DRUG	ispinesib	SB-715992 will be given as a 1 hour intravenous infusion in a dose of 18 mg/m2 once every 3 weeks.

Timeline

• Start date: 2004-11-01
• Primary completion: 2006-09-01
• Completion: 2008-09-01
• First posted: 2004-11-09
• Last updated: 2013-05-17

Locations

7 sites across 1 country: Canada