Phase 1 Clinical Study for Evaluating the Safety and Efficacy of a Transdermal Injection of JX-594 (Thymidine Kinase (-)/GM-CSF(+) Vaccinia Virus) Within the Tumor of Patients With Hepatic Carcinoma
Patients are treated with JX-594 once every three weeks until progression at the site(s) of
injection or until the patient has received a maximum of 4 treatments; four additional
cycles can be administered to patients with an objective response of the injected tumor(s)
(i.e. 8 total treatments possible). Study dose levels are 1e8 pfu, 3e8 pfu, 1e9 pfu and 3e9
pfu per treatment. Standard Phase I dose-escalation guidelines are used, with 2-6 patients
enrolled per cohort (3 if no dose-limiting toxicities are reported).
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the maximum tolerable dose (MTD) and/or the maximum feasible dose (MFD), as well as to evaluate the safety of JX-594 injected within unresectable solid tumor(s) within the liver
Safety evaluation throughout study participation
Yes
David Kirn, MD
Study Director
Jennerex Biotherapeutics (Jennerex, Inc.)
South Korea: Korea Food and Drug Administration (KFDA)
JX594-IT-HEP001
NCT00629759
January 2006
August 2007
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