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

Hepatocellular Carcinoma Clinical Trial

Official title:

Phase I/II Multicenter: Immunotherapy of Hepatocellular Carcinoma by Induction of Anti-alpha Fetoprotein Response

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01128803
• Other study ID #: 06/9-P
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: May 21, 2010
• Last updated: November 6, 2013
• Start date: October 2009
• Est. completion date: October 2010

Study information

• Verified date: November 2013
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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

Locations

Country	Name	City	State
France	University Hospital of Angers	Angers
France	CHD La Roche-sur-Yon	La Roche-sur-Yon
France	Nantes University Hospital	Nantes
France	CH Saint Nazaire	Saint Nazaire

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	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.	3 days after each injection	Yes
Primary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		3 weeks after the last injection	Yes
Primary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		3 months after the last injection	Yes
Secondary	Analysis of T lymphocytes	The secondary aim of the study is to evaluate the anti-AFP immunizing response among patients who received the treatment	before each injection	No
Secondary	Analysis of T lymphocytes		3 weeks after the last injection	No
Secondary	Analysis of T lymphocytes		3 months after the last injection	No