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TK-based Suicide Gene Therapy for Hepatocellular Carcinoma

Primary Purpose

Carcinoma, Hepatocellular

Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
TK99UN
Sponsored by
Clinica Universidad de Navarra, Universidad de Navarra
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular focused on measuring primary liver cancer, hepatoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinica Universitaria de Navarra

Outcomes

Primary Outcome Measures

Adverse Events

Secondary Outcome Measures

Tumor response by WHO criteria

Full Information

First Posted
February 13, 2009
Last Updated
January 15, 2013
Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
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1. Study Identification

Unique Protocol Identification Number
NCT00844623
Brief Title
TK-based Suicide Gene Therapy for Hepatocellular Carcinoma
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 Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
November 2003 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinica Universidad de Navarra, Universidad de Navarra

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Hepatocellular
Keywords
primary liver cancer, hepatoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Genetic
Intervention Name(s)
TK99UN
Other Intervention Name(s)
Adenoviral vector encoding for HSV-TK
Intervention Description
escalated dosis from 2x10e10 to 2x10e12 viral particles injected intratumorally
Primary Outcome Measure Information:
Title
Adverse Events
Time Frame
Daily for the first 16 day, monthly thereafter for 6 months, 3-monthly since then
Secondary Outcome Measure Information:
Title
Tumor response by WHO criteria
Time Frame
at day 63 and months 4, 6, 9 y 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesus Prieto, MD
Organizational Affiliation
Clinica Universitaria de Navarra
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bruno Sangro, MD
Organizational Affiliation
Clinica Universitaria de Navarra
Official's Role
Study Director
Facility Information:
Facility Name
Clinica Universitaria de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
15940613
Citation
Penuelas I, Mazzolini G, Boan JF, Sangro B, Marti-Climent J, Ruiz M, Ruiz J, Satyamurthy N, Qian C, Barrio JR, Phelps ME, Richter JA, Gambhir SS, Prieto J. Positron emission tomography imaging of adenoviral-mediated transgene expression in liver cancer patients. Gastroenterology. 2005 Jun;128(7):1787-95. doi: 10.1053/j.gastro.2005.03.024.
Results Reference
background
PubMed Identifier
20689572
Citation
Sangro B, Mazzolini G, Ruiz M, Ruiz J, Quiroga J, Herrero I, Qian C, Benito A, Larrache J, Olague C, Boan J, Penuelas I, Sadaba B, Prieto J. A phase I clinical trial of thymidine kinase-based gene therapy in advanced hepatocellular carcinoma. Cancer Gene Ther. 2010 Dec;17(12):837-43. doi: 10.1038/cgt.2010.40. Epub 2010 Aug 6.
Results Reference
result

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TK-based Suicide Gene Therapy for Hepatocellular Carcinoma

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