Immunotherapy of Hepatocellular Carcinoma With Gamma Delta T Cells

Hepatocellular Carcinoma Clinical Trial

— ICAR  

Official title:

Immunotherapy of Hepatocellular Carcinoma by Hepatic Intra Arterial Injection of Autologous Gamma-delta T Lymphocytes: A Phase I Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00562666
• Other study ID #: ID RCB 2007-A00249-44
• Secondary ID: CIC 0203/074LOC
• Status: Terminated
• Phase: Phase 1
• First received: November 21, 2007
• Last updated: June 21, 2012
• Start date: February 2008
• Est. completion date: January 2009

Study information

• Verified date: June 2012
• Source: Rennes 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Other:
• T gamma delta lymphocytes
Single hepatic intra arterial administration of increasing doses of T gamma delta lymphocytes

Locations

Country	Name	City	State
France	Département d'Oncologie Médicale - CRLCC Eugène Marquis	Rennes
France	Service de Chirugie Viscérale - Hôpital de Pontchaillou	Rennes
France	Unité de Thérapie Cellulaire, Laboratoire de Cytogénétique et Biologie Cellulaire, CHU Rennes	Rennes

Sponsors (2)

Lead Sponsor	Collaborator
Rennes University Hospital	Innate Pharma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Onset of: thrombosis of hepatic artery, grade 4 liver toxicity, or grade 3 or more allergic, neurological, dermatological, infectious, or respiratory reaction		Within 14 days after treatment	Yes
Secondary	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.		3 months	No