S0351, CNTO 328 in Treating Patients With Unresectable or Metastatic Kidney Cancer
RATIONALE: Monoclonal antibodies, such as CNTO 328, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.
PURPOSE: This phase II trial is studying how well CNTO 328 works in treating patients with unresectable or metastatic kidney cancer.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of CNTO 328, A Monoclonal Antibody Against Interleukin-6 (IL-6), In Patients With Advanced or Metastatic Renal Cell Cancer|
Experimental: CNTO 328
CNTO 328, anti-IL-6 monoclonal antibody; 6 mg/kg, IV, q 2wks x 12 cycles (1 cycle = 2 wks)
Biological: CNTO 328
Anti-IL-6 chimeric monoclonal antibody
Other Name: Siltuximab
- 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 these patients.
- 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.
|Study Chair:||Jacek K. Pinski, MD||USC/Norris Comprehensive Cancer Center|
|Study Chair:||Philip C. Mack, Ph.D.||UC Davis Cancer Center|