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

NCT ID: NCT00265135

Last Updated: 2014-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-08-31
• Study Completion Date: 2006-02-28

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 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.

Conditions

Carcinoma, Renal Cell

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1 (CNTO 328)

In Part 1 of the study, 4 intravenous infusions (IV) \[injection of a substance into a vein\] of CNTO 328 will be administered to patients in 4 dose levels ranging from 1, 3, 6, and 12 mg/kg on days 1, 29, 43, and 57 to determine the maximum tolerated dose for Part 2 of the study.

Group Type: EXPERIMENTAL

CNTO 328

Intervention Type: DRUG

Patients will receive CNTO 328 at dose levels ranging from 1, 3, 6, and 12 mg/kg in Part 1 of the study to determine the maximum tolerated dose for Part 2 of the study. Patients will receive 2 well tolerated dose levels of CNTO 328 from Part 1 of the study every 3 weeks in Part 2 of the study. Patients will receive 6 mg/kg of CNTO 328 every 2 weeks in Part 3 of the study.

Part 2 (CNTO 328)

In Part 2 of the study, 2 well tolerated dose levels of CNTO 328 from Part 1 of the study will be administered every 3 weeks as 4 IV infusions to patients.

Group Type: EXPERIMENTAL

CNTO 328

Intervention Type: DRUG

Patients will receive CNTO 328 at dose levels ranging from 1, 3, 6, and 12 mg/kg in Part 1 of the study to determine the maximum tolerated dose for Part 2 of the study. Patients will receive 2 well tolerated dose levels of CNTO 328 from Part 1 of the study every 3 weeks in Part 2 of the study. Patients will receive 6 mg/kg of CNTO 328 every 2 weeks in Part 3 of the study.

Part 3 (CNTO 328)

In Part 3 of the study, CNTO 328 at a dose level of 6 mg/kg will be administered as IV infusion every 2 weeks for at least 6 doses.

Group Type: EXPERIMENTAL

CNTO 328

Intervention Type: DRUG

Patients will receive CNTO 328 at dose levels ranging from 1, 3, 6, and 12 mg/kg in Part 1 of the study to determine the maximum tolerated dose for Part 2 of the study. Patients will receive 2 well tolerated dose levels of CNTO 328 from Part 1 of the study every 3 weeks in Part 2 of the study. Patients will receive 6 mg/kg of CNTO 328 every 2 weeks in Part 3 of the study.

Interventions

CNTO 328

Patients will receive CNTO 328 at dose levels ranging from 1, 3, 6, and 12 mg/kg in Part 1 of the study to determine the maximum tolerated dose for Part 2 of the study. Patients will receive 2 well tolerated dose levels of CNTO 328 from Part 1 of the study every 3 weeks in Part 2 of the study. Patients will receive 6 mg/kg of CNTO 328 every 2 weeks in Part 3 of the study.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centocor, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Centocor, Inc. Clinical Trial

Role: STUDY_DIRECTOR

Centocor, Inc.

Locations

Brno, , Czechia

Hradec nad Svitavou, , Czechia

Caen, , France

Lyon, , France

Montpellier, , France

Montpellier Cedex 5 N/A, , France

Villejuif, , France

Groningen, , Netherlands

Nijmegen, , Netherlands

Rotterdam, , Netherlands

Birmingham, , United Kingdom

Leeds, , United Kingdom

Manchester, , United Kingdom

Plymouth, , United Kingdom

Countries

Czechia; France; Netherlands; United Kingdom

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=159&filename=CR005278_CSR.pdf

A Phase 1/2 Study of a Chimeric Antibody Against Interleukin-6 (CNTO 328) in Subjects with Metastatic Renal Cell Carcinoma

Other Identifiers

C0328T01

Identifier Type: OTHER

Identifier Source: secondary_id

CR005278

Identifier Type: -

Identifier Source: org_study_id