A Study of CNTO 328 in Subjects With Metastatic Renal Cell Carcinoma - Full Text View

Purpose

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

Condition	Intervention	Phase
Carcinoma, Renal Cell	Drug: CNTO 328	Phase I Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study

Official Title:	A Phase I/II Study of a Chimeric Antibody Against Interleukin-6 (CNTO 328) in Subjects With Metastatic Renal Cell Carcinoma

Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

Secondary outcomes that will be looked at are: PD markers; disease progression; clinical benefit; Quality of Life; Survival

Estimated Enrollment:	127
Study Start Date:	August 2003
Estimated Study Completion Date:	February 2006

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 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00265135

Sponsors and Collaborators

Centocor, Inc.

Investigators


Study Director:	Centocor, Inc. Clinical Trial	Centocor, Inc.

More Information

Study ID Numbers:	CR005278
First Received:	December 13, 2005
Last Updated:	October 19, 2007
ClinicalTrials.gov Identifier:	NCT00265135
Health Authority:	United States: Institutional Review Board

Keywords provided by Centocor, Inc.:

infusions

renal cell cancer

Renal cell carcinoma

Study placed in the following topic categories:

Urogenital Neoplasms

Renal cancer

Urologic Neoplasms

Kidney cancer

Carcinoma

Antibodies

Urologic Diseases

Kidney Neoplasms

Carcinoma, Renal Cell

Kidney Diseases

Adenocarcinoma

Urinary tract neoplasm

Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Centocor, Inc.
Information provided by:	Centocor, Inc.
ClinicalTrials.gov Identifier:	NCT00265135