Back to resultsImmunotherapy of Hepatocellular Carcinoma With Gamma Delta T Cells (ICAR)
Primary Purpose
Hepatocellular Carcinoma
Status
Terminated
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
T gamma delta lymphocytes
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring cell therapy, T lymphocytes, hepatic intra-arterial injection
Eligibility Criteria
Inclusion Criteria:
- Adult over 18
- Hepatocellular carcinoma histologically proven, with at least one measurable tumor
- Non operable tumor
- Alfa foeto protein > 400 ng/ml
- Other treatments (surgery, chemoembolization) non indicated
- Chemoembolization non indicated due to good performance status (WHO 1) or to tumor volume
- Performance status WHO < 2
- Life expectancy > 3 months
Non inclusion Criteria:
- Extra hepatic metastases
- Severe hepatopathy (Child B or C)
- Virus B or C chronic hepatitis
- Chronic cardiac failure
- Uncontrolled severe infectious disease
- Other cancer, if not considered as cured
- Positive serology for HIV or HTLV
- Leucocytes < 3000/mm3 or neutrophils < 1500/mm3
- Platelets < 80000/mm3
- Serum creatinine > 110 µmol/L
- Bilirubin > 35 µmol/L
- AST, ALT, alkaline phosphatase > 5N
- Current immunosuppressive treatment
- Impossibility to comply with scheduled follow-up
- Anatomical situation not permitting the selective injection of the product of cell therapy
- Pregnant or breastfeeding woman, or not using adequate effective contraceptive method
Exclusion Criterion:
- Insufficient number of gamma delta lymphocytes after expansion
Sites / Locations
- Unité de Thérapie Cellulaire, Laboratoire de Cytogénétique et Biologie Cellulaire, CHU Rennes
- Département d'Oncologie Médicale - CRLCC Eugène Marquis
- Service de Chirugie Viscérale - Hôpital de Pontchaillou
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
1
2
3
4
Arm Description
Single hepatic intra arterial administration of 500 millions T gamma delta lymphocytes
Single hepatic intra arterial administration of 1000 millions T gamma delta lymphocytes
Single hepatic intra arterial administration of 2000 millions T gamma delta lymphocytes
Single hepatic intra arterial administration of 4000 millions T gamma delta lymphocytes
Outcomes
Primary Outcome Measures
Onset of: thrombosis of hepatic artery, grade 4 liver toxicity, or grade 3 or more allergic, neurological, dermatological, infectious, or respiratory reaction
Secondary Outcome Measures
Onset of clinical, biological signs or images evocative of lymphocyte-induced tumor cytotoxicity and/or of a persistence of gamma-delta T cells in peripheral blood. Tumor response will be evaluated with the RECIST criteria.
Full Information
NCT ID
NCT00562666
First Posted
November 21, 2007
Last Updated
June 21, 2012
Sponsor
Rennes University Hospital
Collaborators
Innate Pharma
1. Study Identification
Unique Protocol Identification Number
NCT00562666
Brief Title
Immunotherapy of Hepatocellular Carcinoma With Gamma Delta T Cells
Acronym
ICAR
Official Title
Immunotherapy of Hepatocellular Carcinoma by Hepatic Intra Arterial Injection of Autologous Gamma-delta T Lymphocytes: A Phase I Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Terminated
Study Start Date
February 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
Collaborators
Innate Pharma
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
For most patients with hepatocellular carcinoma, surgery or other curative procedures are not possible and only palliative measures could be applied (chemoembolization, targeted drugs, best supportive cares, etc). In the ICAR study, increasing doses of a cell therapy product will be evaluated in patients in a palliative setting. All patients will have one hepatic intra-arterial injection of immunological cells (gamma-delta T lymphocytes) and will be evaluated for safety.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
cell therapy, T lymphocytes, hepatic intra-arterial injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Single hepatic intra arterial administration of 500 millions T gamma delta lymphocytes
Arm Title
2
Arm Type
Experimental
Arm Description
Single hepatic intra arterial administration of 1000 millions T gamma delta lymphocytes
Arm Title
3
Arm Type
Experimental
Arm Description
Single hepatic intra arterial administration of 2000 millions T gamma delta lymphocytes
Arm Title
4
Arm Type
Experimental
Arm Description
Single hepatic intra arterial administration of 4000 millions T gamma delta lymphocytes
Intervention Type
Other
Intervention Name(s)
T gamma delta lymphocytes
Intervention Description
Single hepatic intra arterial administration of increasing doses of T gamma delta lymphocytes
Primary Outcome Measure Information:
Title
Onset of: thrombosis of hepatic artery, grade 4 liver toxicity, or grade 3 or more allergic, neurological, dermatological, infectious, or respiratory reaction
Time Frame
Within 14 days after treatment
Secondary Outcome Measure Information:
Title
Onset of clinical, biological signs or images evocative of lymphocyte-induced tumor cytotoxicity and/or of a persistence of gamma-delta T cells in peripheral blood. Tumor response will be evaluated with the RECIST criteria.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult over 18
Hepatocellular carcinoma histologically proven, with at least one measurable tumor
Non operable tumor
Alfa foeto protein > 400 ng/ml
Other treatments (surgery, chemoembolization) non indicated
Chemoembolization non indicated due to good performance status (WHO 1) or to tumor volume
Performance status WHO < 2
Life expectancy > 3 months
Non inclusion Criteria:
Extra hepatic metastases
Severe hepatopathy (Child B or C)
Virus B or C chronic hepatitis
Chronic cardiac failure
Uncontrolled severe infectious disease
Other cancer, if not considered as cured
Positive serology for HIV or HTLV
Leucocytes < 3000/mm3 or neutrophils < 1500/mm3
Platelets < 80000/mm3
Serum creatinine > 110 µmol/L
Bilirubin > 35 µmol/L
AST, ALT, alkaline phosphatase > 5N
Current immunosuppressive treatment
Impossibility to comply with scheduled follow-up
Anatomical situation not permitting the selective injection of the product of cell therapy
Pregnant or breastfeeding woman, or not using adequate effective contraceptive method
Exclusion Criterion:
Insufficient number of gamma delta lymphocytes after expansion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Luc RAOUL, MD, PhD
Organizational Affiliation
CRLCC Eugène Marquis, Rennes
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric BELLISSANT, MD, PhD
Organizational Affiliation
Rennes University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Unité de Thérapie Cellulaire, Laboratoire de Cytogénétique et Biologie Cellulaire, CHU Rennes
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
Département d'Oncologie Médicale - CRLCC Eugène Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Service de Chirugie Viscérale - Hôpital de Pontchaillou
City
Rennes
Country
France
12. IPD Sharing Statement
Learn more about this trial
Immunotherapy of Hepatocellular Carcinoma With Gamma Delta T Cells
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