Clinical trial NCT01387555: A Phase 2b Study of Modified Vaccinia Virus to Treat Patients Advanced Liver Cancer Who Failed Sorafenib
Official title: A Phase 2b Randomized Trial of JX-594 (Vaccinia GM-CSF / TK-deactivated Virus) Plus Best Supportive Care Versus Best Supportive Care in Patients With Advanced Hepatocellular Carcinoma Who Have Failed Sorafenib Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Liver Cancer
HCC
Keywords: liver cancer
liver tumor
advanced hcc
hepatocellular cancer
Jennerex
HCC
sorafenib
sorafenib failure
sorafenib intolerant
Nexavar
Nexavar failure
JX594
oncolytic virus
vaccinia
viral therapy
JX
Biotherapeutics
HEP018
traverse
biologic
Pexa-Vec
Lead sponsor: Jennerex Biotherapeutics
Sponsor class: INDUSTRY
First posted: 2011-07-04
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to determine whether JX-594 (Pexa-Vec) plus best supportive care is more effective in improving survival than best supportive care in patients with advanced Hepatocellular Carcinoma (HCC) who have failed sorafenib.


Eligibility criteria: KEY Inclusion Criteria:

* Diagnosis of primary HCC by tissue biopsy (histological/cytological diagnosis), or clinical diagnosis
* 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.

KEY Exclusion Criteria:

* Received sorafenib within 14 days prior to randomization
* 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)

Primary outcomes:
measure: Survival
timeFrame: CT scan every six weeks until progression or death, assessed up to 21 months
Secondary outcomes:
measure: Time to Tumor Progression
timeFrame: CT scan every six weeks until progression or death, assessed up to 21 months
measure: Quality of Life
timeFrame: assessed up to 21 months (average)
measure: Tumor Response
timeFrame: CT scan every 6 weeks until progression or death, assessed up to 21 months (average)
measure: Safety profile of JX594
timeFrame: assessed up to 21 months (average)
measure: Time-to-symptomatic-progression
timeFrame: assessed up to 21 months (average)
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Moores University of California San Diego Cancer Center
state: California
city: Orange
country: United States
facility: Chao Family Comprehensive Cancer Center
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: Stanford
country: United States
facility: Stanford Hospital and Clinics
state: California
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Billings
country: United States
facility: Billings Clinic
state: Montana
city: Paterson
country: United States
facility: Saint Joseph's Hospital
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Houston
country: United States
facility: The Methodist Hospital Department of Surgery
state: Texas
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hopsital Research Institute
state: Ontario
city: Strasbourg Cedex
country: France
facility: Hôpitaux Universitaires de Strasbourg - Hôpital Civil
state: Alsace
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire Hôpital Saint André
state: Aquitaine
city: Clermont-Ferrand
country: France
facility: CHU d'Estaing
state: Auvergne
city: Paris
country: France
facility: Hôpital Saint Antoine, CPP Ile de France V
state: Ile-de-France
city: Toulouse
country: France
facility: Hôpital Purpan
state: Midi-Pyrenees
city: Lyon Cedex
country: France
facility: Hôpital de la Croix Rousse
state: Rhone-Alpes
city: München
country: Germany
facility: Klinikum Rechts der Isar der Technischen Universität München
state: Bayern
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
state: Niedersachsen
city: Mainz
country: Germany
facility: Johannes Gutenberg-Universität Mainz
state: Rheinland-Pfalz
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Ansan-si
country: Korea, Republic of
facility: Korea University Ansan Hospital
state: Gyeonggi-Do
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital,Yonsei University Health System
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: TPE
country: Taiwan
facility: National Cheng-Kung University Hospital
city: TPE
country: Taiwan
facility: National Taiwan University Hospital
city: TPE
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Jennerex Biotherapeutics
name: James Burke, MD
role: STUDY_DIRECTOR
References:
citation: 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.