A Study of Recombinant Vaccinia Virus Prior to Sorafenib to Treat Unresectable Primary Hepatocellular Carcinoma
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: July 26, 2010
Last updated: March 5, 2013
Last verified: June 2011
The purpose of this pilot safety study is to evaluate the safety and tolerability of JX-594 (Pexa-Vec) administered intravenously and intratumorally prior to standard sorafenib therapy.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Open-Label Pilot Safety Study of JX-594 (Vaccinia GM-CSF/Thymidine Kinase-Deactivated Virus) Administered by IV Infusion Followed by Intratumoral Injection Prior to Standard Sorafenib Treatment in Patients With Unresectable Primary Hepatocellular Carcinoma|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Jennerex Biotherapeutics:
Primary Outcome Measures:
- Determine safety and tolerability of intravenous infusion of JX-594 followed by intratumoral injections with JX-594 prior to standard sorafenib therapy [ Time Frame: Safety evaluations through 28 days after last dose of JX-594 ] [ Designated as safety issue: Yes ]Adverse events will be collected and assessed to assess safety and tolerability through 28 days after last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Secondary Outcome Measures:
- Determine Disease Control Rate (DCR) at 12 weeks [ Time Frame: Disease control and response assessment at 12 weeks from first JX-594 dose ] [ Designated as safety issue: No ]DCR: confirmed complete response, partial response or stable disease based on modified RECIST and/or Choi response criteria
- Determine radiographic response rate [ Time Frame: Periodically throughout study participation (average of up to 1 year) ] [ Designated as safety issue: No ]Response rate evaluation based on modified RECIST and/or Choi response criteria
- Determine overall survival time [ Time Frame: Ongoing (average of 1 year) ] [ Designated as safety issue: No ]
|Study Start Date:||August 2009|
|Estimated Study Completion Date:||August 2013|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Experimental: JX-594 followed by sorafenib
1e9 pfu (plaque-forming units) total JX-594 dose on each of up to four (4) JX-594 treatment days. Sorafenib is initiated after 3 JX-594 treatments and briefly interrupted if an optional 4th JX-594 treatment is given.
Drug: JX-594 followed by sorafenib
Patients will receive a total dose of 1e9 per treatment starting with one IV dose on Day 1 and injected intratumorally in 1-5 intrahepatic tumors on Day 8 and 22. Starting on Day 25 (3 days after the final JX-594 dose) patients will initiate oral sorafenib therapy twice daily according to standard approved guidelines. An optional maintenance JX-594 dose may be given intratumorally at Week 12 (sorafenib briefly interrupted).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01171651
|Korea, Republic of|
|Pusan National University Hospital|
|Busan, Korea, Republic of|
|Pusan National University Yangsan Hospital|
|Yangsan, Korea, Republic of|
Sponsors and Collaborators
|Study Director:||David H Kirn, MD||Jennerex Biotherapeutics|