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

This study has been completed.
Sponsor:
Information provided by:
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00265135
First received: December 13, 2005
Last updated: November 24, 2010
Last verified: November 2010
History of Changes
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Enrollment: 68
Study Start Date: July 2003
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

No publications provided

ClinicalTrials.gov Identifier: NCT00265135     History of Changes
Other Study ID Numbers: CR005278
Study First Received: December 13, 2005
Last Updated: November 24, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Centocor, Inc.:
Renal cell carcinoma
infusions
renal cell cancer

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013