A Study of Recombinant Vaccinia Virus Prior to Sorafenib to Treat Unresectable Primary Hepatocellular Carcinoma
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|ClinicalTrials.gov Identifier: NCT01171651|
Recruitment Status : Completed
First Posted : July 28, 2010
Last Update Posted : January 20, 2016
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Hepatocellular||Drug: JX-594 followed by sorafenib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||December 2015|
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).
- 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 ]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).
- Determine Disease Control Rate (DCR) at 12 weeks [ Time Frame: Disease control and response assessment at 12 weeks from first JX-594 dose ]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) ]Response rate evaluation based on modified RECIST and/or Choi response criteria
- Determine overall survival time [ Time Frame: Ongoing (average of 1 year) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01171651
|Korea, Republic of|
|Pusan National University Hospital|
|Busan, Korea, Republic of|
|Pusan National University Yangsan Hospital|
|Yangsan, Korea, Republic of|
|Study Director:||David H Kirn, MD||Jennerex Biotherapeutics|