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

May 21, 2010
November 6, 2013
October 2009
October 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01128803 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Immunotherapy of Hepatocellular Carcinoma by Induction of Anti-alpha Fetoprotein Response
Phase I/II Multicenter: Immunotherapy of Hepatocellular Carcinoma by Induction of Anti-alpha Fetoprotein Response

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.

Not Provided
Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatocellular Carcinoma
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
October 2010
October 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01128803
06/9-P
No
Nantes University Hospital
Nantes University Hospital
Not Provided
Principal Investigator: Jérôme GOURNAY, Dr CHU Nantes
Nantes University Hospital
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP