NCT00978107

Trial of TG4023 Combined With Flucytosine in Liver Tumors

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Transgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-09-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2009-09-16
• Last updated: 2014-07-16

Locations

6 sites across 1 country: France