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A Phase 2a Study of Modified Vaccinia Virus to Treat Sorafenib-naïve Advanced Liver Cancer (FLASH)

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. Identifier: NCT01636284
Recruitment Status : Completed
First Posted : July 10, 2012
Last Update Posted : January 20, 2016
Information provided by (Responsible Party):
SillaJen, Inc. ( Jennerex Biotherapeutics )

Brief Summary:
This study is to determine how effectively JX-594 (Pexa-Vec) will prolong life in patients with advanced Hepatocellular Carcinoma (HCC) who have not been previously treated with sorafenib, and the safe administration of JX-594 in five weekly IV infusions.

Condition or disease Intervention/treatment Phase
Hepatocellular Carinoma Biological: JX-594 recombinant vaccina GM-CSF Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-Arm, Open-Label Phase 2 Study of JX 594 (Thymidine Kinase-Deactivated Vaccinia Virus Plus GM-CSF) Administered by Weekly Intravenous (IV) Infusions in Sorafenib-naïve Patients With Advanced Hepatocellular Carcinoma (HCC)
Study Start Date : June 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Sorafenib

Arm Intervention/treatment
Experimental: JX-594 recombinant vaccina GM-CSF
JX-594 recombinant vaccina GM-CSF
Biological: JX-594 recombinant vaccina GM-CSF
Enrolled patients will receive 5 weekly IV infusions on Days 1, 8, 15, 22, and 29. After Day 43, if their disease has improved or remained stable and they have not started other cancer therapy, they may be able to continue to receive JX-594 via IV infusion every three weeks. This treatment extension may continue until radiologic progressive disease, initiation of other cancer therapy, or patient withdrawal.

Primary Outcome Measures :
  1. Tumor response [ Time Frame: CT scans evaluated at Weeks 6, 12, 18, 24, 30, 36, 42, 48 ]
    CT scans every six weeks until documented progression or date of death, whichever comes first, assessed up to 104 weeks.

Secondary Outcome Measures :
  1. Safety profile of JX-594 [ Time Frame: Safety assessments related to JX-594 up to 28 days after last IV infusion ]
    Safety will be assessed by the number of adverse events (AEs) and serious adverse events (SAEs) up to 28 days after last JX-594 administration for an expected average of 52 weeks

  2. Time to progression [ Time Frame: From the earliest date of either documented progression or death of any cause, assessed up to 104 weeks ]
  3. Overall survival [ Time Frame: From date of final clinic visit until date of death, assessed up to 104 weeks ]
    After radiographic progression, beginning other cancer therapy, or early withdrawal, patients and/or their specified contacts will continue to be contacted approximately every 4 weeks for survival and information on subsequent anti-cancer therapy including dose, duration, significant associated toxicities and efficacy.

Information from the National Library of Medicine

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

KEY Inclusion Criteria:

  • Histologic or cytologic confirmation of advanced primary hepatocellular carcinoma (HCC)
  • Measurable tumor (at least one tumor with ≥1 cm LD of contrast-enhancement during the arterial phase on CT scanning)
  • ECOG performance status 0, 1 or 2
  • Child-Pugh Class A; or Child-Pugh Class B7 without clinically significant ascites
  • Platelet count ≥50,000 plts/mm3
  • WBC count ≥2,000 cells/mm3 and ≤50,000 cells/mm3
  • Hemoglobin ≥10 g/dL
  • Adequate liver function

KEY Exclusion Criteria:

  • Received sorafenib as previous treatment for HCC for more than 14 days
  • History of severe exfoliative skin condition (e.g., eczema or atopic dermatitis requiring systemic therapy for > 4 weeks)
  • Prior treatment with JX-594
  • Known significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication
  • Severe or unstable cardiac disease
  • Viable CNS malignancy associated with clinical symptoms
  • Pregnant or nursing an infant
  • Significant bleeding event within the last 12 months.

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 identifier (NCT number): NCT01636284

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United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85259
United States, Texas
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Korea, Republic of
Pusan National University Hospital
Pusan, Korea, Republic of
Pusan National University Yangsan Hospital
Yangsan, Korea, Republic of
University Clinic of Navarra
Navarra, Spain
Sponsors and Collaborators
Jennerex Biotherapeutics
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Study Director: James Burke, MD Jennerex Biotherapeutics

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Responsible Party: Jennerex Biotherapeutics Identifier: NCT01636284     History of Changes
Other Study ID Numbers: JX594-IV-HEP021
First Posted: July 10, 2012    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016
Keywords provided by SillaJen, Inc. ( Jennerex Biotherapeutics ):
Liver Cancer
first line HCC
Additional relevant MeSH terms:
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Poxviridae Infections
DNA Virus Infections
Virus Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs