Immunotherapy of Hepatocellular Carcinoma by Induction of Anti-alpha Fetoprotein Response - Full Text View

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:

Genetic and Rare Diseases Information Center resources: Liver Cancer

U.S. FDA Resources

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:

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 (Adult, Senior)
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


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 September 29, 2016