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

Overview

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.

Full Title of Study: “Phase I/II Multicenter: Immunotherapy of Hepatocellular Carcinoma by Induction of Anti-alpha Fetoprotein Response”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2010

Interventions

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability
    • Time Frame: 3 days after each injection
    • 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
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability
    • Time Frame: 3 months after the last injection

Secondary Measures

  • Analysis of T lymphocytes
    • Time Frame: before each injection
    • 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
  • Analysis of T lymphocytes
    • Time Frame: 3 months after the last injection

Participating in This Clinical Trial

Preinclusion 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Nantes University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jérôme GOURNAY, Dr, Principal Investigator, Nantes University Hospital

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