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Anti-CTLA-4 Human Monoclonal Antibody CP-675,206 in Patients With Advanced Hepatocellular Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01008358
Recruitment Status : Completed
First Posted : November 4, 2009
Last Update Posted : June 8, 2012
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra

Study Description
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Brief Summary:
CP-675,206 (tremelimumab) is a fully humanized monoclonal antibody that binds to activated T lymphocytes and by enhancing their activation may produce a stimulation of the immune response against tumoral or viral antigens. In this clinical trial, the ability of tremelimumab to produce tumor responses among hepatitis C virus-infected patients with hepatocellular carcinoma not amenable to other therapies will be explored. Besides, the effect on the replication of the virus will be analysed.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Hepatitis C Virus Chronic Infection Biological: CP 675,206 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Anti-CTLA-4 Human Monoclonal Antibody CP-675,206 in Patients With Advanced Hepatocellular Carcinoma
Study Start Date : December 2008
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Tumor response by Response Evaluation Criteria In Solid Tumors (RECIST)

Secondary Outcome Measures :
  1. Changes in Hepatitis C Virus (HCV) viral load

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unequivocal diagnosis of HCC
  • unresectable disease not amenable to locoregional treatment.
  • a 4-week washout period after sorafenib or any other systemic agent
  • a 2-month washout period after internal or external radiation
  • HCV chronic infection
  • Child-Pugh stage A or B
  • Measurable disease according to RECIST criteria
  • ECOG < 2
  • expected survival > 3 months
  • Adequate liver, renal and blood functions
  • ability to sign informed consent

Exclusion Criteria:

  • previous treatment with an anti-CTL-4 agent
  • serious infections or disease compromising general health status
  • autoimmune disease that requires therapy
  • treatment with immunosuppressors
  • treatment with investigational agents
  • other neoplasms except skin and bladder superficial tumors
  • pregnancy or lactation
  • SNC metastasis
  • HIV infection
  • relevant heart disease (NYHA class III or IV)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01008358


Locations
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Spain
Hospital Universitario Reina Sofía
Córdoba, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Clinica Universitaria de Navarra
Pamplona, Spain
Sponsors and Collaborators
Clinica Universidad de Navarra, Universidad de Navarra
Pfizer
Investigators
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Study Director: Jesús Prieto-Valtuena, MD, PhD Clinica Universidad de Navarra
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier: NCT01008358    
Other Study ID Numbers: CT-2007-01
EudraCT number 2008-001177-15
First Posted: November 4, 2009    Key Record Dates
Last Update Posted: June 8, 2012
Last Verified: June 2012
Additional relevant MeSH terms:
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Hepatitis C
Persistent Infection
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Hepatitis
Liver Diseases
Digestive System Diseases
Blood-Borne Infections
Communicable Diseases
Infections
 Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Disease Attributes
Pathologic Processes
Tremelimumab
Antineoplastic Agents