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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01171651
Recruitment Status : Completed
First Posted : July 28, 2010
Last Update Posted : January 20, 2016
Sponsor:
Information provided by (Responsible Party):
SillaJen, Inc. ( Jennerex Biotherapeutics )

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Drug: JX-594 followed by sorafenib Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2009
Actual Primary Completion Date : February 2013
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Sorafenib

Arms and Interventions
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Arm Intervention/treatment
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).


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Determine overall survival time [ Time Frame: Ongoing (average of 1 year) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological confirmation or clinical/laboratory diagnosis of primary hepatocellular carcinoma (HCC)
  • Cancer is not surgically resectable for cure
  • Child Pugh A or B
  • Performance Score: KPS score of ≥ 70
  • Platelet count ≥ 50,000 plts/mm3
  • Total bilirubin ≤ 2.5 x ULN
  • AST, ALT < 5.0 x ULN
  • Acceptable coagulation status: INR ≤ 1.5 x ULN
  • Acceptable kidney function: Serum creatinine < 2.0 mg/dL
  • Sorafenib naive or refractory to sorafenib therapy Tumor Status: At least one intrahepatic tumor, and at least ≥50% of the total intrahepatic viable tumor mass, measurable by CT and injectable under imaging-guidance (note: injected and/or viable tumors must be previously untreated or ≥20% increase in size since preceding local-regional treatment).

Exclusion Criteria:

  • Known contraindications to sorafenib
  • Pregnant or nursing an infant
  • Significant immunodeficiency due to underlying illness (e.g. hematological malignancies, congenital immunodeficiencies and/or HIV infection/AIDS) and/or medication (e.g. high-dose systemic corticosteroids)
  • History of exfoliative skin condition (e.g. severe eczema, ectopic dermatitis, or similar skin disorder) that at some stage has required systemic therapy
  • Clinically significant and/or rapidly accumulating ascites, peri-cardial and/or pleural effusions
  • Severe or unstable cardiac disease
  • Current, known CNS malignancy
  • Use of anti-platelet or anti-coagulation medication
  • Use of the following anti-viral agents: ribavirin, adefovir, cidofovir (within 7 days prior to the first treatment), and PEG-IFN (within 14 days prior to the first treatment).
  • Patients with household contacts who meet any of these criteria unless alternate living arrangements can be made during the patient's active dosing period and for 7 days following the last dose of study medication:
  • Pregnant or nursing an infant
  • Children < 12 months old
  • History of exfoliative skin condition that at some stage has required systemic therapy
  • Significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Korea, Republic of
Pusan National University Hospital
Busan, Korea, Republic of
Pusan National University Yangsan Hospital
Yangsan, Korea, Republic of
Sponsors and Collaborators
Jennerex Biotherapeutics
Investigators
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Study Director: David H Kirn, MD Jennerex Biotherapeutics
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jennerex Biotherapeutics
ClinicalTrials.gov Identifier: NCT01171651    
Other Study ID Numbers: JX594-HEP016
First Posted: July 28, 2010    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: June 2011
Keywords provided by SillaJen, Inc. ( Jennerex Biotherapeutics ):
Vaccinia
Vaccinia Virus
JX-594
Jennerex
Primary Hepatocellular Carcinoma
 Primary Liver Cancer
Liver Cancer
Sorafenib
Nexavar
Pexa-Vec
Additional relevant MeSH terms:
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Vaccinia
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
 Liver Diseases
Poxviridae Infections
DNA Virus Infections
Virus Diseases
Infections
Sorafenib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action