TK-based Suicide Gene Therapy for Hepatocellular Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00844623
Recruitment Status : Completed
First Posted : February 16, 2009
Last Update Posted : January 16, 2013
Information provided by (Responsible Party):
Bruno Sangro Gomez-Acebo, Clinica Universidad de Navarra, Universidad de Navarra

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Genetic: TK99UN Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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)
Study Start Date : December 2002
Actual Primary Completion Date : November 2003
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Genetic: TK99UN
    escalated dosis from 2x10e10 to 2x10e12 viral particles injected intratumorally
    Other Name: Adenoviral vector encoding for HSV-TK

Primary Outcome Measures :
  1. Adverse Events [ Time Frame: Daily for the first 16 day, monthly thereafter for 6 months, 3-monthly since then ]

Secondary Outcome Measures :
  1. Tumor response by WHO criteria [ Time Frame: at day 63 and months 4, 6, 9 y 12 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00844623

Clinica Universitaria de Navarra
Pamplona, Spain, 31008
Sponsors and Collaborators
Clinica Universidad de Navarra, Universidad de Navarra
Principal Investigator: Jesus Prieto, MD Clinica Universitaria de Navarra
Study Director: Bruno Sangro, MD Clinica Universitaria de Navarra

Publications of Results:
Other Publications:
Responsible Party: Bruno Sangro Gomez-Acebo, Main investigator, Clinica Universidad de Navarra, Universidad de Navarra Identifier: NCT00844623     History of Changes
Other Study ID Numbers: TK99UN-HCC1
First Posted: February 16, 2009    Key Record Dates
Last Update Posted: January 16, 2013
Last Verified: January 2013

Keywords provided by Bruno Sangro Gomez-Acebo, Clinica Universidad de Navarra, Universidad de Navarra:
primary liver cancer, hepatoma

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases