A Phase 2b Study of Modified Vaccinia Virus to Treat Patients Advanced Liver Cancer Who Failed Sorafenib
NCT ID: NCT01387555
Last Updated: 2015-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
129 participants
INTERVENTIONAL
2008-12-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
Patients on Arm A will receive 1 e9 pfu (plaque forming units) total dose of JX-594 (Vaccinia GM-CSF / TK-deactivated Virus) on each of six (6) treatments over 18 weeks.
JX-594 recombinant vaccina GM-CSF
Patients will be randomised 2:1 to Arm A or Arm B and will receive 6 treatments on days 1, 8, 22, week 6, week 12, and week 18 plus best supportive care as needed.
Arm B
Patients on the control arm (Arm B) will have best supportive care over 18 weeks.
Best Supportive Care
Patients will be randomised 2:1 to Arm A or Arm B and will receive best supportive care as needed.
Interventions
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JX-594 recombinant vaccina GM-CSF
Patients will be randomised 2:1 to Arm A or Arm B and will receive 6 treatments on days 1, 8, 22, week 6, week 12, and week 18 plus best supportive care as needed.
Best Supportive Care
Patients will be randomised 2:1 to Arm A or Arm B and will receive best supportive care as needed.
Eligibility Criteria
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Inclusion Criteria
* Previously treated with sorafenib for ≥ 14 days and has discontinued sorafenib treatment at least 14 days prior to randomization due to either intolerance or radiographic progression NOTE: Sorafenib is NOT required to be the most recent treatment received for HCC
* ECOG performance status 0, 1 or 2
* Child-Pugh Class A; or Child-Pugh Class B7 without clinically significant ascites
* Hematocrit ≥30% or Hemoglobin ≥10 g/dL
* Tumor status: Measurable viable tumor in the liver and injectable under imaging-guidance; At least one tumor in the liver that has not received prior local-regional treatment OR that has exhibited \>25% growth in viable tumor size since prior local-regional treatment.
Exclusion Criteria
* Received systemic anti-cancer therapy other than sorafenib within 28 days of randomization
* Prior treatment with JX-594
* Platelet count \< 50,000 PLT/ mm3
* Total white blood cell count \< 2,000 cells/mm3
* Prior or planned organ transplant
* 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
* History of inflammatory skin condition (e.g., eczema requiring previous treatment, atopic dermatitis)
18 Years
ALL
No
Sponsors
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Jennerex Biotherapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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James Burke, MD
Role: STUDY_DIRECTOR
Jennerex Biotherapeutics
Locations
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Moores University of California San Diego Cancer Center
La Jolla, California, United States
Chao Family Comprehensive Cancer Center
Orange, California, United States
California Pacific Medical Center
San Francisco, California, United States
Stanford Hospital and Clinics
Stanford, California, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Billings Clinic
Billings, Montana, United States
Saint Joseph's Hospital
Paterson, New Jersey, United States
Montefiore Medical Center
The Bronx, New York, United States
Gabrail Cancer Center
Canton, Ohio, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
The Methodist Hospital Department of Surgery
Houston, Texas, United States
University of Alberta
Edmonton, Alberta, Canada
University of British Columbia
Vancouver, British Columbia, Canada
Juravinski Cancer Centre
Hamilton, Ontario, Canada
Ottawa Hopsital Research Institute
Ottawa, Ontario, Canada
Hôpitaux Universitaires de Strasbourg - Hôpital Civil
Strasbourg, Alsace, France
Centre Hospitalier Universitaire Hôpital Saint André
Bordeaux, Aquitaine, France
Hôpital de la Croix Rousse
Lyon, Auvergne-Rhône-Alpes, France
CHU d'Estaing
Clermont-Ferrand, Auvergne, France
Hôpital Purpan
Toulouse, Midi-Pyrenees, France
Hôpital Saint Antoine, CPP Ile de France V
Paris, Île-de-France Region, France
Klinikum Rechts der Isar der Technischen Universität München
München, Bavaria, Germany
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany
Johannes Gutenberg-Universität Mainz
Mainz, Rhineland-Palatinate, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Queen Mary Hospital
Hong Kong, , Hong Kong
Korea University Ansan Hospital
Ansan-si, Gyeonggi-do, South Korea
Kyungpook National University Hospital
Daegu, , South Korea
Pusan National University Hospital
Pusan, , South Korea
Asan Medical Center
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital,Yonsei University Health System
Seoul, , South Korea
Pusan National University Yangsan Hospital
Yangsan, , South Korea
National Cheng-Kung University Hospital
Taipei, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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References
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Moehler M, Heo J, Lee HC, Tak WY, Chao Y, Paik SW, Yim HJ, Byun KS, Baron A, Ungerechts G, Jonker D, Ruo L, Cho M, Kaubisch A, Wege H, Merle P, Ebert O, Habersetzer F, Blanc JF, Rosmorduc O, Lencioni R, Patt R, Leen AM, Foerster F, Homerin M, Stojkowitz N, Lusky M, Limacher JM, Hennequi M, Gaspar N, McFadden B, De Silva N, Shen D, Pelusio A, Kirn DH, Breitbach CJ, Burke JM. Vaccinia-based oncolytic immunotherapy Pexastimogene Devacirepvec in patients with advanced hepatocellular carcinoma after sorafenib failure: a randomized multicenter Phase IIb trial (TRAVERSE). Oncoimmunology. 2019 Jun 3;8(8):1615817. doi: 10.1080/2162402X.2019.1615817. eCollection 2019.
Related Links
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Sponsor Website
Other Identifiers
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JX594-HEP018
Identifier Type: -
Identifier Source: org_study_id
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