Trial | NCT00844623  Report issue

Title

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)

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    tk99un ...

  • Study Participants

    10
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 Started
Dec 31
2002
Primary Completion
Nov 30
2003
Study Completion
Mar 31
2008
Last Update
Jan 16
2013
Estimate

Genetic TK99UN

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

  • Other names: Adenoviral vector encoding for HSV-TK

Criteria 

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
No Results Posted