16
Participants
Start Date
September 30, 2009
Primary Completion Date
September 30, 2011
Study Completion Date
September 30, 2011
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."
Institut Paoli Calmette,, Marseille
Institut Claudius Regaud, Toulouse
Centre René Gauducheau, Saint-Herblain
Hôpitaux Universitaires de Strasbourg, Strasbourg
Hôpitaux Civils de Colmar, Colmar
Hôpitaux Civils de Lyon,, Pierre-Bénite
Lead Sponsor
Transgene
INDUSTRY