Immunotherapy of Hepatocellular Carcinoma With Gamma Delta T Cells (ICAR)

This study has been terminated.
Sponsor:
Collaborator:
Innate Pharma
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT00562666
First received: November 21, 2007
Last updated: June 21, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Hepatocellular Carcinoma
Other: T gamma delta lymphocytes
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Immunotherapy of Hepatocellular Carcinoma by Hepatic Intra Arterial Injection of Autologous Gamma-delta T Lymphocytes: A Phase I Study

Resource links provided by NLM:


Further study details as provided by Rennes University Hospital:

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 [ Time Frame: Within 14 days after treatment ] [ Designated as safety issue: Yes ]

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. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: February 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Single hepatic intra arterial administration of 500 millions T gamma delta lymphocytes
Other: T gamma delta lymphocytes
Single hepatic intra arterial administration of increasing doses of T gamma delta lymphocytes
Experimental: 2
Single hepatic intra arterial administration of 1000 millions T gamma delta lymphocytes
Other: T gamma delta lymphocytes
Single hepatic intra arterial administration of increasing doses of T gamma delta lymphocytes
Experimental: 3
Single hepatic intra arterial administration of 2000 millions T gamma delta lymphocytes
Other: T gamma delta lymphocytes
Single hepatic intra arterial administration of increasing doses of T gamma delta lymphocytes
Experimental: 4
Single hepatic intra arterial administration of 4000 millions T gamma delta lymphocytes
Other: T gamma delta lymphocytes
Single hepatic intra arterial administration of increasing doses of T gamma delta lymphocytes

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00562666

Locations
France
Département d'Oncologie Médicale - CRLCC Eugène Marquis
Rennes, France, 35042
Service de Chirugie Viscérale - Hôpital de Pontchaillou
Rennes, France
Unité de Thérapie Cellulaire, Laboratoire de Cytogénétique et Biologie Cellulaire, CHU Rennes
Rennes, France, 35000
Sponsors and Collaborators
Rennes University Hospital
Innate Pharma
Investigators
Principal Investigator: Jean-Luc RAOUL, MD, PhD CRLCC Eugène Marquis, Rennes
Study Chair: Eric BELLISSANT, MD, PhD Rennes University Hospital
  More Information

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT00562666     History of Changes
Other Study ID Numbers: ID RCB 2007-A00249-44, CIC 0203/074, LOC 06/07
Study First Received: November 21, 2007
Last Updated: June 21, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Rennes University Hospital:
cell therapy
T lymphocytes
hepatic intra-arterial injection

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on August 28, 2014