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)
18 Years
80 Years
Both
Carcinoma, Hepatocellular
Trial Information
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)
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Adverse Events
Outcome Time Frame:
Daily for the first 16 day, monthly thereafter for 6 months, 3-monthly since then
Safety Issue:
Yes
Principal Investigator
Jesus Prieto, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Clinica Universitaria de Navarra
Authority:
Spain: Spanish Agency of Medicines
Study ID:
TK99UN-HCC1
NCT ID:
NCT00844623
Start Date:
December 2002
Completion Date:
March 2008
Related Keywords:
- Carcinoma, Hepatocellular
- primary liver cancer, hepatoma
- Carcinoma
- Carcinoma, Hepatocellular
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