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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier:
NCT01008358
First received: November 3, 2009
Last updated: June 7, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Hepatocellular Carcinoma
Hepatitis C Virus Chronic Infection
Biological: CP 675,206
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Clinica Universidad de Navarra, Universidad de Navarra:

Primary Outcome Measures:
  • Tumor response by Response Evaluation Criteria In Solid Tumors (RECIST) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in Hepatitis C Virus (HCV) viral load [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: December 2008
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01008358

Locations
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
Study Director: Jesús Prieto-Valtuena, MD, PhD Clinica Universidad de Navarra
  More Information

No publications provided by Clinica Universidad de Navarra, Universidad de Navarra

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier: NCT01008358     History of Changes
Other Study ID Numbers: CT-2007-01, EudraCT number 2008-001177-15
Study First Received: November 3, 2009
Last Updated: June 7, 2012
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Hepatitis C
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Flaviviridae Infections
Hepatitis
Hepatitis, Viral, Human
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
RNA Virus Infections
Virus Diseases
Antibodies, Monoclonal
Tremelimumab
Antineoplastic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014