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A Study of Recombinant Vaccinia Virus to Treat Unresectable Primary Hepatocellular Carcinoma

NCT00554372 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-02-04

Study results available
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Summary

The purpose of this research study is to determine whether JX-594 (Pexa-Vec) has significant anti-tumoral activity and tolerability in primary hepatocellular carcinoma and to determine the dose to be used in further testing.

Conditions

  • Carcinoma, Hepatocellular

Interventions

GENETIC

JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF)

Patients will be randomized 1:1 to one of two total doses (1e8 or 1e9 pfu)and injected intratumorally in 1-5 intrahepatic tumors on Days 1, 15, and 29.

Sponsors & Collaborators

  • Jennerex Biotherapeutics

    lead INDUSTRY

Principal Investigators

  • David Kirn, MD · Jennerex Biotherapeutics

  • Tony Reid, Md, PhD · University of California San Diego, Moores Cancer Center

  • Jeong Heo, MD, PhD · Pusan National University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2011-12-31
Completion
2013-02-28

Countries

  • United States
  • Canada
  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00554372 on ClinicalTrials.gov