A Phase II Study of CNTO 328, A Monoclonal Antibody Against Interleukin-6 (IL-6), In Patients With Advanced or Metastatic Renal Cell Cancer
- Assess the probability of response (confirmed complete and partial responses) in
patients with unresectable or metastatic renal cell cancer treated with CNTO 328.
- Assess the 6-month progression-free survival probability and median overall survival in
- Evaluate the qualitative and quantitative toxicities of this treatment.
- Investigate, in a preliminary manner, the association of tumor response with potential
markers of anti-interleukin-6 activity.
OUTLINE: This is a multicenter study.
Patients receive CNTO 328 IV over 2 hours on day 1. Treatment repeats every 2 weeks for 6
courses in the absence of disease progression or unacceptable toxicity. Patients achieving
complete or partial response after 6 courses of therapy may receive an additional 6 courses.
After completion of study treatment, patients are followed periodically for 3 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Jacek K. Pinski, MD
USC/Norris Comprehensive Cancer Center
United States: Food and Drug Administration