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Completed

NCT Number: NCT00844623

TK-based Suicide Gene Therapy for Hepatocellular Carcinoma

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.

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Key information

Conditions

Carcinoma, Hepatocellular Adenocarcinoma Carcinoma Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinica Universitaria de Navarra

Pamplona, 31008, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TK99UN

Genetic

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

Other names: Adenoviral vector encoding for HSV-TK

Primary outcomes

  1. Adverse Events

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

Secondary outcomes

  1. Tumor response by WHO criteria

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

Sponsors and collaborators

Lead sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Other

Registry information

Official study title

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)

Important dates

Study start
2002
Primary completion
2003
Study completion
2008
First posted
Feb 16, 2009
Registry last updated
Jan 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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