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Trial of TG4023 Combined With Flucytosine in Liver Tumors

NCT00978107 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2014-07-16

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Transgene

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00978107 on ClinicalTrials.gov