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

June 21, 2012 updated by: Rennes University Hospital

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rennes, France, 35000
        • Unité de Thérapie Cellulaire, Laboratoire de Cytogénétique et Biologie Cellulaire, CHU Rennes
      • Rennes, France, 35042
        • Département d'Oncologie Médicale - CRLCC Eugène Marquis
      • Rennes, France
        • Service de Chirugie Viscérale - Hôpital de Pontchaillou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Within 14 days after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Collaborators

Innate Pharma

Investigators

  • Principal Investigator: Jean-Luc RAOUL, MD, PhD, CRLCC Eugène Marquis, Rennes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

November 21, 2007

First Submitted That Met QC Criteria

November 21, 2007

First Posted (Estimate)

November 22, 2007

Study Record Updates

Last Update Posted (Estimate)

June 22, 2012

Last Update Submitted That Met QC Criteria

June 21, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID RCB 2007-A00249-44
  • CIC 0203/074
  • LOC 06/07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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