Status:
COMPLETED
A Study of CNTO 328 in Subjects With Metastatic Renal Cell Carcinoma
Lead Sponsor:
Centocor, Inc.
Conditions:
Carcinoma, Renal Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to better understand the safety, tolerability and distribution of CNTO 328 in the bloodstream.
Detailed Description
This research study uses a type of drug called anti-IL-6 monoclonal antibody, also known as CNTO 328. CNTO 328 is a new experimental drug. This study is trying to better understand the safety, the tol...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2006
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00265135
Start Date
August 1 2003
End Date
February 1 2006
Last Update
July 3 2014
Active Locations (14)
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1
Brno, Czechia
2
Hradec nad Svitavou, Czechia
3
Caen, France
4
Lyon, France