Clinical trial NCT00562666: Immunotherapy of Hepatocellular Carcinoma With Gamma Delta T Cells
Official title: Immunotherapy of Hepatocellular Carcinoma by Hepatic Intra Arterial Injection of Autologous Gamma-delta T Lymphocytes: A Phase I Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Hepatocellular Carcinoma
Keywords: cell therapy
T lymphocytes
hepatic intra-arterial injection
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
Collaborators: name: Innate Pharma
First posted: 2007-11-22
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Onset of: thrombosis of hepatic artery, grade 4 liver toxicity, or grade 3 or more allergic, neurological, dermatological, infectious, or respiratory reaction
timeFrame: Within 14 days after treatment
Secondary outcomes:
measure: 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.
timeFrame: 3 months
Other outcomes:
Locations:
city: Rennes
country: France
facility: Unité de Thérapie Cellulaire, Laboratoire de Cytogénétique et Biologie Cellulaire, CHU Rennes
city: Rennes
country: France
facility: Département d'Oncologie Médicale - CRLCC Eugène Marquis
city: Rennes
country: France
facility: Service de Chirugie Viscérale - Hôpital de Pontchaillou
Study officials:
affiliation: CRLCC Eugène Marquis, Rennes
name: Jean-Luc RAOUL, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rennes University Hospital
name: Eric BELLISSANT, MD, PhD
role: STUDY_CHAIR
References: