Ispinesib in Treating Patients With Metastatic or Unresectable Kidney Cancer

Stage IV Renal Cell Cancer Clinical Trial

Official title: A Phase II Study of SB-715992 (NSC-727990, IND-70273) in Advanced Renal Cell Cancer

Status Completed

Clinical Trial Summary

This phase II trial is studying how well ispinesib works in treating patients with metastatic or unresectable kidney cancer. Ispinesib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To assess the efficacy of SB-715992 in patients with advanced renal cell cancer who have received at least one prior therapy. This will be achieved by a multi-center, single arm phase II study to evaluate the proportion of patients who achieve a complete or partial response with this agent.

SECONDARY OBJECTIVES:

I. To assess the overall survival. II. To assess the time to progression. III. To evaluate the qualitative and quantitative toxicities of this regimen.

OUTLINE: This is a multicenter study.

Patients receive ispinesib (SB-715992) IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 3 years. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Recurrent Renal Cell Cancer
• Stage III Renal Cell Cancer
• Stage IV Renal Cell Cancer

• NCT number: NCT00354250
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Completed
• Phase: Phase 2
• Start date: May 2006