Trial of TG4023 Combined With Flucytosine in Liver Tumors

July 15, 2014 updated by: Transgene

A Phase I, Open-label, Dose-escalating Study of the Safety or Percutaneous Intra-tumoral Injection of TG4023 (MVA-FCU1) Combined With Systemic Administration of 5-fluorocytosine in Patients With Primary or Secondary Hepatic Tumors.

This trial is a phase I, open-label, dose-escalating study of the safety or percutaneous intra-tumoral injection of TG4023 (MVA-FCU1) combined with systemic administration of 5-fluorocytosine in patients with primary or secondary hepatic tumors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

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
      • Colmar, France, 68000
        • Hopitaux Civils de Colmar
      • Marseille, France, 13000
        • Institut Paoli Calmette,
      • Pierre Benite, France, 69495
        • Hôpitaux Civils de Lyon,
      • Saint Herblain, France, 44800
        • Centre Rene Gauducheau
      • Strasbourg, France, 67000
        • Hôpitaux Universitaires de Strasbourg
      • Toulouse, France, 31000
        • Institut Claudius Regaud

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with advanced disease without any other standard of care treatment options:

    • hepatic metastases of colorectal cancer (CRC) or of other cancers
    • Hepatocellular carcinoma (HCC)
  • At least one unresectable target tumor located in the liver, measuring 2-5 cm and accessible to IT administration of TG4023 and amenable to radiological measurement using RECIST,
  • Weight ≤ 100 kg,
  • Patients with stable disease, who have to discontinue chemotherapy because of intolerance,
  • ECOG performance status ≤ 2,
  • Life expectancy ≥ 3 months,

  • Hematology:

    • Absolute neutrophil count > 1,500/mm3,
    • Hemoglobin > 9g/dL,
    • Platelet count > 100,000/mm3,
    • Prothrombin time international normalized ratio (INR) ≤ 2; partial thromboplastin time ≤ 1.66 times upper limit of normal (ULN),

  • Biochemistry:

    • Total bilirubin ≤ 3 x ULN,

    • Aspartate amino-transferase (AST), alanine amino-transferase (ALT), alkaline phosphatase

      • 5.0 x ULN,
    • Creatinin clearance ≥ 40 mL/min,
    • Total albumin ≥ 30 g/L,
  • Anti-vitamin K anticoagulants should have been switched for low-molecular weight heparin prior to TG4023 injection,
  • Signed, written Independent Ethics Committee (IEC)-approved informed consent.

Exclusion Criteria:

  • Child-Pugh stage C hepatic insufficiency,
  • Impaired renal function (creatinin clearance < 40 mL/min),
  • Known deficiency in dihydropyrimidine dehydrogenase (DPD) or total DPD deficiency diagnosed at baseline in those patients not previously treated with 5-FU-related compounds,
  • Ascites,
  • Brain metastases,
  • Significant impairment of gastro-intestinal (GI) tract absorption capacity, such as total gastrectomy, gastric mucosal atrophy, extensive intestinal resections or malabsorption disease will not be treated by oral 5-FC,
  • History of bleeding disorders,
  • Pregnant or breast-feeding women,
  • Human Immunodeficiency Virus (HIV) positive,
  • Chronic use of immunodepressants within 4 weeks prior to TG4023 injection or immune-depressed patients,
  • Hypersensitivity to 5-FC,
  • Hypersensitivity to egg proteins,
  • Concomitant or previous chemotherapy or targeted therapy within 4 weeks prior to TG4023 injection and last treatment with bevacizumab (Avastin®) within 2 months prior to TG4023 injection,
  • Concomitant treatment with anti-inflammatory drugs: systemic cortico-steroids and non-steroidal anti-inflammatory drugs (NSAIDs),
  • Prior gene therapy,
  • Prior participation in any other research protocol involving an IMP within 2 months prior to TG4023 injection,
  • Major surgery within 6 weeks of TG4023 injection,

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: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximal tolerated dose
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Tumor response of injected and non-injected lesions Viral dissemination Proof of concept: 5-FU concentration in plasma and in tumors
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Transgene

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2009

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

September 15, 2009

First Submitted That Met QC Criteria

September 15, 2009

First Posted (Estimate)

September 16, 2009

Study Record Updates

Last Update Posted (Estimate)

July 16, 2014

Last Update Submitted That Met QC Criteria

July 15, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TG4023.01
  • Eudra CT 2008-005024-90

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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