Trial of TG4023 Combined With Flucytosine in Liver Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

September 30, 2009

Primary Completion Date

September 30, 2011

Study Completion Date

September 30, 2011

Conditions
Hepatocellular Carcinoma
Interventions
BIOLOGICAL

MVA-FCU1, flucytosine

"1. TG4023: single IT injection; possibility to re-administer once,~ * Percutaneous IT injections, under radiological or ultrasound imaging guidance~ * Dose-escalating schedule of administration: 107 pfu (Cohort #1), 108 pfu (Cohort #2) and 4x108 pfu (Cohort #3),~ * MTD injected to up to 3 different lesions (Cohort #4)~2. 5-FC (5-fluorocytosine)/flucytosine~ * Dose and dosing schedule:~ * Daily starting dose of 200 mg/kg; daily dose will be adjusted after measurement of 5-FC plasma concentration at steady state, which should be kept below 100 mg/L~ * Duration: 2 weeks.~ * Possible routes of administration:~ * PO: 500 mg tablets, qid~ * IV: 1% 250 mL vials, 45-minute infusions."

Trial Locations (6)

13000

Institut Paoli Calmette,, Marseille

31000

Institut Claudius Regaud, Toulouse

44800

Centre René Gauducheau, Saint-Herblain

67000

Hôpitaux Universitaires de Strasbourg, Strasbourg

68000

Hôpitaux Civils de Colmar, Colmar

69495

Hôpitaux Civils de Lyon,, Pierre-Bénite

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Transgene

INDUSTRY