NCT00057889

Monoclonal Antibody Therapy in Treating Patients With Metastatic Renal Cell Cancer

A Phase II Open-Label Study of Single Agent MDX-010 for the Treatment of IL-2 Refractory or IL-2 Ineligible Patients With Stage IV Renal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: National Institutes of Health Clinical Center (CC) · NIH
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have metastatic renal cell cancer (kidney cancer) that is refractory to treatment with interleukin-2 or unable to be treated with interleukin-2.

Detailed description

OBJECTIVES: * Determine the activity of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody in patients with metastatic clear cell renal cancer who are refractory to or ineligible for interleukin-2. * Determine the impact of this drug on T-cell number and phenotype in these patients. OUTLINE: This is an open-label study. Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody IV over 90 minutes once every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with an ongoing partial response may receive additional courses of therapy. Patients are followed at 4 weeks, every 3 months for 1 year, every 6 months for 2 years, and then annually until disease progression. PROJECTED ACCRUAL: A total of 21-103 patients will be accrued for this study within 2-4 years.

Conditions

• Kidney Cancer

Interventions

Type	Name	Description
BIOLOGICAL	ipilimumab

Timeline

• Start date: 2003-02-01
• Primary completion: 2007-10-01
• Completion: 2008-02-01
• First posted: 2003-04-09
• Last updated: 2012-03-15

Locations

1 site across 1 country: United States