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First Study of the Safety of CNTO 888 in Patients With Solid Tumors

This study is currently recruiting participants.
Verified by Centocor, Inc., October 2008

Sponsored by: Centocor, Inc.
Information provided by: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT00537368
  Purpose

The purpose of this study is to determine if CNTO 888 is safe and to determine how long CNTO 888 stays in the body and what effects it might have on cancer tumors.


Condition Intervention Phase
Cancer
Drug: CNTO 888
Phase I

MedlinePlus related topics:   Cancer   

Drug Information available for:   CNTO 888   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:   A Phase 1 Study of CNTO 888, a Human Monoconal Antibody Against CC-Chemokine Ligand 2 in Subjects With Solid Tumors

Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:
  • Evaluate the safety and pharmacokinetics (rate of movement in the body and then the clearance) of CNTO 888 administered as multiple intravenous (IV) infusions in patients with solid tumors throughout the course of the study.

Secondary Outcome Measures:
  • Assess the pharmacodynamics (action of drug on body systems), immune response and clinical effects (tumor response and time to disease progression) of CNTO888 when administered as multiple IV infusions in patients with solid tumors throughout the study.

Estimated Enrollment:   54
Study Start Date:   August 2007

Detailed Description:

CNTO 888 is a monoclonal antibody. Antibodies are substances in the body that are involved in many biological processes. CNTO 888 is thought to work by blocking a protein called CC-Chemokine Ligand 2 (CCL2). In research studies CCL2 has been shown to increase the growth of new blood vessels which help the tumor to survive. When new blood vessels do not grow, tumors cannot get the food or oxygen they need to grow. Blocking CCL2 may help fight disease.This study consists of two parts, Part A and Part B. In Part A, five different groups of patients will be treated with five different, increasing dose levels of CNTO 888. In Part B, two of the dose levels of CNTO 888 will be tested further in different treatment schedules. CNTO 888 is given by intravenous (into the vein) infusion. Between 1 and 30 patients with advanced cancer will take part in Part A of the study. Between 24 and 33 patients with advanced cancer will take part in Part B of the study.There are three phases in part A of the study. Screening phase, which may last up to 4 weeks. Treatment phase, which may last up to 8 weeks (4 treatments) and can be extended for an extra 9 weeks (4 extra treatments) in case the patient's tumor is not getting bigger. The total treatment period could be up to 17 weeks. Follow up phase will include an end of treatment visit 4 weeks after the last infusion of CNTO 888, visits through week 18 after last infusion as well as long term collection of follow up data. After Part A is completed, up to two doses will be selected for evaluation in part B. In Part B, patients will be placed into one of 3 study groups. There are three phases in Part B of this study. The screening phase, which may last up to 4 weeks. The treatment phase, which may last up to 9 weeks (4 treatments). If the patient's tumor is not getting bigger, the patient's treatment phase may be extended up to 12 weeks (4 treatments). The total treatment period could be up to 21 weeks. The follow up phase will include an end of treatment visit 4 weeks after the last infusion of CNTO 888, visits through week 18 after last infusion as well as long-term collection of follow up data. Safety and effectiveness evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests, vital signs (such as blood pressure), physical examinations and collection of information about the occurrence and severity of adverse events.

In Part A of this study, patients will receive either 0.3 , 1.0, 3.0, 10, or 15 mg/kg CNTO 888. The time between the first and second infusion is 4 weeks, with all of the following infusions will be given 2 weeks apart. Patients eligible for Part B will be assigned to either the lower dose selected from Part A, given every 2 weeks or the higher dose selected from Part A given either every 2 weeks or every 3 weeks. All patients may be in the study for 18 weeks after their last infusion.

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

Criteria

Inclusion Criteria:

  • Patients with solid tumors that have progressed on or after all available standard therapy
  • Histological or cytological documentation of specific tumor type
  • Evidence of measurable or evaluable metastatic disease
  • Anticipated life expectancy is >= 12 weeks

Exclusion Criteria:

  • Treatment with systemic cancer therapy or local radiotherapy within 4 weeks
  • Received any investigational drug/agent within 4 weeks
  • Major surgery within 4 weeks of first dose of study agent
  • Serious concurrent illness (medical or psychiatric), altered mental status (eg, dementia) or any uncontrolled medical condition (eg, uncontrolled diabetes)
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537368

Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:     info1@veritasmedicine.com    

Locations
United States, Texas
Recruiting
      San Antonio, Texas, United States, 78229
United Kingdom
Recruiting
      Sutton, United Kingdom, SM2 5PT

Sponsors and Collaborators
Centocor, Inc.

Investigators
Study Director:     Centocor, Inc. Clinical Trial     Centocor, Inc.    
  More Information


To learn how to participate in this trial please click here.  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CR013699
First Received:   September 28, 2007
Last Updated:   October 3, 2008
ClinicalTrials.gov Identifier:   NCT00537368
Health Authority:   United States: Food and Drug Administration

Keywords provided by Centocor, Inc.:
CNTO 888  
cancer  
solid tumor  
Phase 1  
infusion  

Study placed in the following topic categories:
Antibodies

ClinicalTrials.gov processed this record on October 24, 2008




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