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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Hepatocellular Carcinoma	Procedure: injection of the cell therapy product	Phase 1; Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Phase I/II Multicenter: Immunotherapy of Hepatocellular Carcinoma by Induction of Anti-alpha Fetoprotein Response
Study Start Date :	October 2009
Actual Primary Completion Date :	October 2010
Actual Study Completion Date :	October 2010

Arms and Interventions

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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

Outcome Measures

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Primary Outcome Measures :

1. 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.
2. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 3 weeks after the last injection ]
3. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 3 months after the last injection ]

Secondary Outcome Measures :

1. 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
2. Analysis of T lymphocytes [ Time Frame: 3 weeks after the last injection ]
3. Analysis of T lymphocytes [ Time Frame: 3 months after the last injection ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Nantes University Hospital
ClinicalTrials.gov Identifier:	NCT01128803 History of Changes
Other Study ID Numbers:	06/9-P
First Posted:	May 24, 2010
Last Update Posted:	November 7, 2013
Last Verified:	November 2013

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