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)
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Dec 2002
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 13, 2009
CompletedFirst Posted
Study publicly available on registry
February 16, 2009
CompletedJanuary 16, 2013
January 1, 2013
11 months
February 13, 2009
January 15, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse Events
Daily for the first 16 day, monthly thereafter for 6 months, 3-monthly since then
Secondary Outcomes (1)
Tumor response by WHO criteria
at day 63 and months 4, 6, 9 y 12
Interventions
escalated dosis from 2x10e10 to 2x10e12 viral particles injected intratumorally
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinica Universitaria de Navarra
Pamplona, 31008, Spain
Related Publications (2)
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.
PMID: 15940613BACKGROUNDSangro 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.
PMID: 20689572RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jesus Prieto, MD
Clinica Universitaria de Navarra
- STUDY DIRECTOR
Bruno Sangro, MD
Clinica Universitaria de Navarra
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Main investigator
Study Record Dates
First Submitted
February 13, 2009
First Posted
February 16, 2009
Study Start
December 1, 2002
Primary Completion
November 1, 2003
Study Completion
March 1, 2008
Last Updated
January 16, 2013
Record last verified: 2013-01