TK-based Suicide Gene Therapy for Hepatocellular Carcinoma

University of Navarra

Status and phase

Completed

Phase 1

Conditions

Carcinoma, Hepatocellular

Treatments

Genetic: TK99UN

Study type

Interventional

Funder types

Other

Identifiers

NCT00844623

TK99UN-HCC1

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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