Immunotherapy of Hepatocellular Carcinoma With Gamma Delta T Cells

Phase 1

Terminated

• Conditions: Hepatocellular Carcinoma
• Interventions: Other: T gamma delta lymphocytes

• Registration Number: NCT00562666
• Lead Sponsor: Rennes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-11-21
• Study First Submitted QC: 2007-11-21
• Study First Posted: 2007-11-22
• Study Start: 2008-02
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-21
• Last Update Posted: 2012-06-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	T gamma delta lymphocytes	Single hepatic intra arterial administration of 500 millions T gamma delta lymphocytes
2	T gamma delta lymphocytes	Single hepatic intra arterial administration of 1000 millions T gamma delta lymphocytes
3	T gamma delta lymphocytes	Single hepatic intra arterial administration of 2000 millions T gamma delta lymphocytes
4	T gamma delta lymphocytes	Single hepatic intra arterial administration of 4000 millions T gamma delta lymphocytes

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Unité de Thérapie Cellulaire, Laboratoire de Cytogénétique et Biologie Cellulaire, CHU Rennes; 🇫🇷 Rennes, France

Département d'Oncologie Médicale - CRLCC Eugène Marquis; 🇫🇷 Rennes, France

Service de Chirugie Viscérale - Hôpital de Pontchaillou; 🇫🇷 Rennes, France