TK-based Suicide Gene Therapy for Hepatocellular Carcinoma

Clinica Universidad de Navarra, Universidad de Navarra10 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Carcinoma, Hepatocellular

Interventions

TK99UNGENETIC

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Clinica Universitaria de Navarra

Pamplona, Spain

Outcomes

Primary Outcomes

Adverse Events

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

Secondary Outcomes

Tumor response by WHO criteria

Time frame: at day 63 and months 4, 6, 9 y 12

Data from ClinicalTrials.gov

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