Trial of TG4023 Combined With Flucytosine in Liver Tumors
Information source: Transgene
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatocellular Carcinoma
Intervention: MVA-FCU1, flucytosine (Biological)
Phase: Phase 1
Status: Recruiting
Sponsored by: Transgene Overall contact:
Jean Emmanuel Kurtz, MD, Phone: 33.388 12 84 36, Email: J-Emmanuel.KURTZ@chru-strasbourg.fr
Summary
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, Control: Uncontrolled, 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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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,
Locations and Contacts
Jean Emmanuel Kurtz, MD, Phone: 33.388 12 84 36, Email: J-Emmanuel.KURTZ@chru-strasbourg.fr
Hôpitaux Civils de Colmar, Colmar 68000, France; Not yet recruiting
Fares Husseini, MD, Phone: +33.(0)389 12 41 04, Email: fares.husseini@ch-colmar.rss.fr
Fares Husseini, MD, Principal Investigator
Institut Paoli Calmette,, Marseille 13000, France; Not yet recruiting
Marc Giovannini, MD, Phone: +33.(0)491 22 37 40, Email: giovanninim@wanadoo.fr
Marc Giovannini, MD, Principal Investigator
Erwan Bories, MD, Sub-Investigator
Hôpitaux Civils de Lyon,, Pierre Benite 69495, France; Not yet recruiting
Véronique Trillet-Lenoir, MD, Phone: +33.(0)478 86 43 15, Email: veronique.trillet-lenoir@chu-lyon.fr
Cécile Fournel-Federico, MD, Sub-Investigator
Centre René Gauducheau, Saint Herblain 44800, France; Not yet recruiting
Jaafar Bennouna, MD, Phone: +33.(0)240 67 99 00, Email: j-bennouna@fnclcc.fr
Jaafar Bennouna, MD, Principal Investigator
Hôpitaux Universitaires de Strasbourg, Strasbourg 67000, France; Recruiting
J Emmanuel Kurtz, MD, Phone: +33.(0)388 12 84 36, Email: J-Emmanuel.KURTZ@chru-strasbourg.fr
J Emmanuel Kurtz, MD, Principal Investigator
Patrick Dufour, MD, Sub-Investigator
Institut Claudius Regaud, Toulouse 31000, France; Not yet recruiting
Jean-Pierre Delord, MD, Phone: +33.(0)561 42 41 14, Email: Delord.Jean-Pierre@claudiusregaud.fr
Jean-Pierre Delord, MD, Principal Investigator
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: September 17, 2009
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