drugset / Trial / NCT00978107
Trial of TG4023 Combined With Flucytosine in Liver Tumors
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2009-09
- Primary completion
- 2011-09
- Completion
- 2011-09
Publications
- Background Erbs P, Findeli A, Kintz J, Cordier P, Hoffmann C, Geist M, Balloul JM. Modified vaccinia virus Ankara as a vector for suicide gene therapy. Cancer Gene Ther. 2008 Jan;15(1):18-28. doi: 10.1038/sj.cgt.7701098. Epub 2007 Nov 9.
- Husseini F, Delord JP, Fournel-Federico C, Guitton J, Erbs P, Homerin M, Halluard C, Jemming C, Orange C, Limacher JM, Kurtz JE. Vectorized gene therapy of liver tumors: proof-of-concept of TG4023 (MVA-FCU1) in combination with flucytosine. Ann Oncol. 2017 Jan 1;28(1):169-174. doi: 10.1093/annonc/mdw440.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Flucytosine | Small molecule | 200 mg/kg | Oral |
| Subject | MVA-FCU1 | Unknown | 1e+07 unknown | Other |
| Subject | MVA-FCU1 | Unknown | 1e+08 unknown | Other |
| Subject | MVA-FCU1 | Unknown | 4e+08 unknown | Other |