Status:
COMPLETED
TK-based Suicide Gene Therapy for Hepatocellular Carcinoma
Lead Sponsor:
Clinica Universidad de Navarra, Universidad de Navarra
Conditions:
Carcinoma, Hepatocellular
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
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 hepatocel...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00844623
Start Date
December 1 2002
End Date
March 1 2008
Last Update
January 16 2013
Active Locations (1)
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1
Clinica Universitaria de Navarra
Pamplona, Spain, 31008