Status:
COMPLETED
Trial of TG4023 Combined With Flucytosine in Liver Tumors
Lead Sponsor:
Transgene
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 patie...
Eligibility Criteria
Inclusion
- 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
- 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
- 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,
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00978107
Start Date
September 1 2009
End Date
September 1 2011
Last Update
July 16 2014
Active Locations (6)
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1
Hôpitaux Civils de Colmar
Colmar, France, 68000
2
Institut Paoli Calmette,
Marseille, France, 13000
3
Hôpitaux Civils de Lyon,
Pierre-Bénite, France, 69495
4
Centre René Gauducheau
Saint-Herblain, France, 44800