A Study of CNTO 328 in Subjects With Metastatic Renal Cell Carcinoma

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to better understand the safety, tolerability and distribution of CNTO 328 in the bloodstream.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centocor, Inc.
• Treatments: Antibodies, Monoclonal; Siltuximab

Criteria

Inclusion Criteria:

• Clinical diagnosis (histologically confirmed, preferably) of metastatic renal cell carcinoma with documented metastases beyond the level of the regional lymphatics (ie, any T, any N, M1 disease)

• Measurable or evaluable disease (Part 1); measurable disease (Part 2 and Part 3)

• Documented disease progression based on objective tumor assessment (Part 2 and Part 3), proven by tumor measurements on 2 computerized tomography scans within 6 months prior to enrollment

• Life expectancy greater than or equal to 6 months at screening

• Serum C-reactive protein (CRP): detectable ( 4 mg/L or more) according to the standard assay of the core laboratory (Part 1 and Part 2); serum CRP detectable to 30 mg/L or more (Part 3)

Exclusion Criteria:

• Received any investigational drug within 30 days, whichever is longer

• History of receiving murine or chimeric proteins or human/murine recombination products (such as BE8 and other anti-IL-6 monoclonal antibodies)

• Serious concurrent illness or significant cardiac disease characterized by significant ischemic coronary disease or congestive heart failure

• Chronic infection, prior history of recurrent infection, or clinically important active infection

• Presence of a transplanted solid organ (with the exception of a corneal transplant more than 3 months prior to screening) or having received an allogeneic bone marrow transplant or peripheral blood stem cell transplant