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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00844623

Enrollment

Registered

2009-02-16

Start date

2002-12-31

Completion date

2008-03-31

Last updated

2013-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Hepatocellular

Keywords

primary liver cancer, hepatoma

Brief 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.

Interventions

GENETICTK99UN

escalated dosis from 2x10e10 to 2x10e12 viral particles injected intratumorally

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Unequivocal diagnosis of hepatocellular carcinoma according to histological confirmation or EASL-AASLD criteria * Contraindication for surgical treatment of the disease * Detectable disease by imaging * Ability to give informed consent and to express the willingness to fulfill protocol requirements during the study

Exclusion criteria

* Current pregnancy or breast-feeding * Acute infection * Positive anti-HIV antibodies * Hematologic alterations not attributable to hypersplenism, or in any case, intense neutropenia and thrombocytopenia, defined as neutrophil count lower than 0,5/pL or platelet count lower than 20/pL * Participation in other clinical trial during the previous month

Design outcomes

Primary

Measure	Time frame
Adverse Events	Daily for the first 16 day, monthly thereafter for 6 months, 3-monthly since then

Secondary

Measure	Time frame
Tumor response by WHO criteria	at day 63 and months 4, 6, 9 y 12

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026