Immunotherapy of Hepatocellular Carcinoma by Induction of Anti-alpha Fetoprotein Response
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| ClinicalTrials.gov Identifier: NCT01128803 |
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Recruitment Status :
Terminated
First Posted : May 24, 2010
Last Update Posted : November 7, 2013
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Sponsor:
Nantes University Hospital
Information provided by (Responsible Party):
Nantes University Hospital
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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 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 |
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
Primary Outcome 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 Outcome 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 ]
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
| Responsible Party: | Nantes University Hospital |
| ClinicalTrials.gov Identifier: | NCT01128803 History of Changes |
| Other Study ID Numbers: |
06/9-P |
| First Posted: | May 24, 2010 Key Record Dates |
| Last Update Posted: | November 7, 2013 |
| Last Verified: | November 2013 |
Keywords provided by Nantes University Hospital:
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Hepatocellular carcinoma immunotherapy alpha foetoprotein dendritic cells |
Additional relevant MeSH terms:
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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 |