A Phase I/II Study of a Chimeric Antibody Against Interleukin-6 (CNTO 328) in Subjects With Metastatic Renal Cell Carcinoma
18 Years
N/A
Both
Carcinoma, Renal Cell
Trial Information
A Phase I/II Study of a Chimeric Antibody Against Interleukin-6 (CNTO 328) in Subjects With Metastatic Renal Cell Carcinoma
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 tolerability (side effects), and the distribution of the drug in the blood
stream. The effects of CNTO 328 in patients with renal cell carcinoma are currently unknown.
However, recent data has shown that treatment with another anti-IL-6 monoclonal antibody
reduces the symptoms of renal cell carcinoma.
The study is divided in 3 parts. Part 1 is the phase I portion of the study and evaluated
the safety of CNTO 328 in subjects with metastatic renal cell carcinoma. Part 2 and 3 will
evaluate efficacy and safety of the drug in this patient population.
Inclusion Criteria:
- Age = 18 years old
- diagnosis of metastatic renal cell carcinoma
- documented disease progression
Exclusion Criteria:
- Received any investigational drug within past 30 days
- 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The primary objectives of Part 1 of the study are to assess the toxicity, pharmacokinetics, and pharmacodynamics of CNTO 328 in subjects with metastatic renal cell carcinoma, so that 2 possible dose levels can be evaluated in Part 2.
Principal Investigator
Centocor, Inc. Clinical Trial
Investigator Role:
Study Director
Investigator Affiliation:
Centocor, Inc.
Authority:
United States: Institutional Review Board
Study ID:
CR005278
NCT ID:
NCT00265135
Start Date:
July 2003
Completion Date:
February 2006
Related Keywords:
- Carcinoma, Renal Cell
- Renal cell carcinoma
- infusions
- renal cell cancer
- Carcinoma
- Carcinoma, Renal Cell
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