Immunotherapy of Hepatocellular Carcinoma by Induction of Anti-alpha Fetoprotein Response

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01128803
First received: May 21, 2010
Last updated: November 6, 2013
Last verified: November 2013
  Purpose

The secretion by tumor cells of alpha fetoprotein (AFP) was observed in 50 to 60% of hepatocellular carcinoma. The AFP can be used as a marker for tumor recurrence after treatment and may be considered as a tumor antigen specific for hepatocellular carcinoma.The aim of the project is to use the alpha fetoprotein (AFP) as a tumor antigen and to propose an approach of immunotherapy for hepatocellular carcinoma based on the injection of autologous dendritic cells loaded with specific peptides of AFP.


Condition Intervention Phase
Hepatocellular Carcinoma
Procedure: injection of the cell therapy product
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Multicenter: Immunotherapy of Hepatocellular Carcinoma by Induction of Anti-alpha Fetoprotein Response

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 3 days after each injection ] [ Designated as safety issue: Yes ]
    The main aim of this study is to test the absence of toxicity of the injection of autologist dendritic cells loaded with specific peptides of the AFP, for patients with hepatocellular carcinoma and already treated.

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 3 weeks after the last injection ] [ Designated as safety issue: Yes ]
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 3 months after the last injection ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Analysis of T lymphocytes [ Time Frame: before each injection ] [ Designated as safety issue: No ]
    The secondary aim of the study is to evaluate the anti-AFP immunizing response among patients who received the treatment

  • Analysis of T lymphocytes [ Time Frame: 3 weeks after the last injection ] [ Designated as safety issue: No ]
  • Analysis of T lymphocytes [ Time Frame: 3 months after the last injection ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: October 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: injection of the cell therapy product
    Between D-15 and D-30: Cytapheresis D0: 1st injection of the cell therapy product D21: 2nd injection of the cell therapy product D42: 3rd injection of the cell therapy product and 1 injection of dendritic cells not loaded D45: cutaneous biopsies if induration > 2mm
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Pre-inclusion Criteria :

  • Adults (men or women) aged between 18 and 80 years
  • Patients affiliated to a social security reimbursement system
  • Signed informed consent
  • Hepatocellular carcinoma
  • At least one dosage with Alpha-foeto-protein ≥ 40 ng/ml
  • Patient already treated with chemoembolization, percutaneous destruction (alcohol or radiofrequency), surgery or Sorafenib.

Inclusion Criteria:

  • Negative test for pregnancy or effective contraception
  • Patient HIV-, Hep B-, Hep C-, HTLV1 and 2-, Syphilis-
  • HLA A 0201 group

Exclusion Criteria:

  • Life expectancy < 3 months
  • Pregnancy or breast-feeding
  • Severe auto-immune disease
  • Another malignant tumor except if considered as cured since more than 5 years
  • History of uncontrolled psychiatric condition
  • Risk factors of Creutzfeldt Jacobs disease
  • Decompensated cirrhosis(ascites or Child-Pugh score greater than 8)
  • Hepatic transplantation
  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: NCT01128803

Locations
France
University Hospital of Angers
Angers, France, 49000
CHD La Roche-sur-Yon
La Roche-sur-Yon, France, 85000
Nantes University Hospital
Nantes, France
CH Saint Nazaire
Saint Nazaire, France, 44000
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Jérôme GOURNAY, Dr CHU Nantes
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01128803     History of Changes
Other Study ID Numbers: 06/9-P
Study First Received: May 21, 2010
Last Updated: November 6, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Nantes University Hospital:
Hepatocellular carcinoma
immunotherapy
alpha foetoprotein
dendritic cells

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on July 28, 2014