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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jennerex Biotherapeutics
ClinicalTrials.gov Identifier:
NCT00554372
First received: November 2, 2007
Last updated: July 22, 2015
Last verified: October 2011
Results First Received: May 12, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Carcinoma, Hepatocellular
Intervention: Genetic: JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were randomized 1:1 to a treatment arm (dosage group). Randomization into the dosing groups was stratified by whether the Hepatocellular carcinoma was virally associated (hepatitis B virus or hepatitis C virus) or not virally associated.

Reporting Groups
  Description
Low Dose 1e8 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
High Dose 1e9 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.

Participant Flow:   Overall Study
    Low Dose     High Dose  
STARTED     14     16  
COMPLETED     14     16  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Low Dose 1e8 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
High Dose 1e9 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
Total Total of all reporting groups

Baseline Measures
    Low Dose     High Dose     Total  
Number of Participants  
[units: participants]
  14     16     30  
Age  
[units: years]
Mean (Standard Deviation)
  67.1  (11.5)     62.9  (12.7)     64.9  (12.2)  
Gender  
[units: participants]
     
Female     4     3     7  
Male     10     13     23  
Region of Enrollment  
[units: participants]
     
United States     5     5     10  
Canada     3     4     7  
Korea, Republic of     6     7     13  



  Outcome Measures
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1.  Primary:   Proportion of Subjects Achieving Disease Control (Non-progressive Disease) at 8 Weeks After Initiation of Treatment   [ Time Frame: Initial progression status and response assessment at 8 weeks from first dose ]

2.  Secondary:   Safety and Tolerability of JX-594 Administered at Two Dose Levels   [ Time Frame: Safety and tolerability were evaluated throughout the 8 week period of study participation ]

3.  Secondary:   Number of Subjects Achieving Disease Control as Determined Using Intrahepatic Modified RECIST Criteria   [ Time Frame: At week 8 ]

4.  Secondary:   Median Overall Survival   [ Time Frame: To 760 days post treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Clinical Trial Assistant
Organization: SillaJen Biotherapeutics, Inc.
phone: 415 281 8886
e-mail: jmack@sillajen.com


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: Jennerex Biotherapeutics
ClinicalTrials.gov Identifier: NCT00554372     History of Changes
Other Study ID Numbers: JX594-IT-HEP007
Study First Received: November 2, 2007
Results First Received: May 12, 2015
Last Updated: July 22, 2015
Health Authority: United States: Food and Drug Administration