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Trial of TG4023 Combined With Flucytosine in Liver Tumors

Information source: Transgene
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatocellular Carcinoma

Intervention: MVA-FCU1, flucytosine (Biological)

Phase: Phase 1

Status: Completed

Sponsored by: Transgene


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.

Clinical Details

Official title: 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 design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Maximal tolerated dose

Secondary outcome: Tumor response of injected and non-injected lesions Viral dissemination Proof of concept: 5-FU concentration in plasma and in tumors


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- 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


- 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,

Locations and Contacts

Hôpitaux Civils de Colmar, Colmar 68000, France

Institut Paoli Calmette,, Marseille 13000, France

Hôpitaux Civils de Lyon,, Pierre Benite 69495, France

Centre René Gauducheau, Saint Herblain 44800, France

Hôpitaux Universitaires de Strasbourg, Strasbourg 67000, France

Institut Claudius Regaud, Toulouse 31000, France

Additional Information

Related publications:

Erbs P, Findeli A, Kintz J, Cordier P, Hoffmann C, Geist M, Balloul JM. Modified vaccinia virus Ankara as a vector for suicide gene therapy. Cancer Gene Ther. 2008 Jan;15(1):18-28. Epub 2007 Nov 9.

Starting date: September 2009
Last updated: July 15, 2014

Page last updated: August 20, 2015

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