NCT00844623

TK-based Suicide Gene Therapy for Hepatocellular Carcinoma

Phase I Clinical Trial Of Gene Therapy For Hepatocellular Carcinoma By Intratumoral Injection Of TK99UN (An Adenoviral Vector Containing The Thymidine Kinase Of Herpes Simplex Virus)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether activation of a prodrug after intratumoral gene transfer is safe in humans, and to determine dose levels for further clinical development.

Detailed description

The study is a phase I clinical trial evaluating the intratumoral injection of defective adenovirus containing HSVtk (the thymidine kinase of herpes simplex virus), in patients with advanced hepatocellular carcinoma that were not amenable to curative therapy. The study was conducted in a single center in Spain. Five consecutive cohorts of two patients received increasing doses of the vector by intratumoral injection and equal doses of either intravenous ganciclovir or oral valganciclovir. The dose received by each consecutive cohort of patients was progressively higher according to a prefixed scale.

Conditions

• Carcinoma, Hepatocellular

Interventions

Type	Name	Description
GENETIC	TK99UN	escalated dosis from 2x10e10 to 2x10e12 viral particles injected intratumorally

Timeline

• Start date: 2002-12-01
• Primary completion: 2003-11-01
• Completion: 2008-03-01
• First posted: 2009-02-16
• Last updated: 2013-01-16

Locations

1 site across 1 country: Spain