TK-based Suicide Gene Therapy for Hepatocellular Carcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bruno Sangro Gomez-Acebo, Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier:
NCT00844623
First received: February 13, 2009
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Carcinoma, Hepatocellular
Genetic: TK99UN
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Clinica Universidad de Navarra, Universidad de Navarra:

Primary Outcome Measures:
  • Adverse Events [ Time Frame: Daily for the first 16 day, monthly thereafter for 6 months, 3-monthly since then ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Tumor response by WHO criteria [ Time Frame: at day 63 and months 4, 6, 9 y 12 ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: December 2002
Study Completion Date: March 2008
Primary Completion Date: November 2003 (Final data collection date for primary outcome measure)
Intervention Details:
    Genetic: TK99UN
    escalated dosis from 2x10e10 to 2x10e12 viral particles injected intratumorally
    Other Name: Adenoviral vector encoding for HSV-TK
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00844623

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

Publications:
Responsible Party: Bruno Sangro Gomez-Acebo, Main investigator, Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier: NCT00844623     History of Changes
Other Study ID Numbers: TK99UN-HCC1
Study First Received: February 13, 2009
Last Updated: January 15, 2013
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra:
primary liver cancer, hepatoma

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

ClinicalTrials.gov processed this record on October 23, 2014