Trial record 1 of 1 for:    NCT01387555
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A Phase 2b Study of Modified Vaccinia Virus to Treat Patients Advanced Liver Cancer Who Failed Sorafenib (TRAVERSE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Jennerex Biotherapeutics.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Jennerex Biotherapeutics
ClinicalTrials.gov Identifier:
NCT01387555
First received: June 27, 2011
Last updated: January 13, 2014
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Hepatocellular Carcinoma
Liver Cancer
HCC
Biological: JX-594 recombinant vaccina GM-CSF
Other: Best Supportive Care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Jennerex Biotherapeutics:

Primary Outcome Measures:
  • Survival [ Time Frame: CT scan every six weeks until progression or death, assessed up to 21 months ] [ Designated as safety issue: No ]
    Determine overall survival for patients receiving JX-594 plus best supportive care (Arm A) compared with those patients receiving best supportive care (Arm B) in patients with advanced hepatocellular carcinoma (HCC) who have failed sorafenib treatment.


Secondary Outcome Measures:
  • Time to Tumor Progression [ Time Frame: CT scan every six weeks until progression or death, assessed up to 21 months ] [ Designated as safety issue: No ]
    Determine time-to-tumor-progression (TTP) for Arm A compared with Arm B based on mRECIST for HCC.

  • Quality of Life [ Time Frame: assessed up to 21 months (average) ] [ Designated as safety issue: No ]
    Determine the Quality of Life (QoL) of patients treated in Arm A compared with Arm B.

  • Tumor Response [ Time Frame: CT scan every 6 weeks until progression or death, assessed up to 21 months (average) ] [ Designated as safety issue: No ]
    Determine tumor response based on mRECIST for HCC of Arm A versus Arm B

  • Safety profile of JX594 [ Time Frame: assessed up to 21 months (average) ] [ Designated as safety issue: Yes ]
    Safety will be assessed by the number of adverse events (AEs) and serious adverse events (SAEs)

  • Time-to-symptomatic-progression [ Time Frame: assessed up to 21 months (average) ] [ Designated as safety issue: No ]
    Determine time to progression of Arm A compared to Arm B.


Enrollment: 129
Study Start Date: August 2011
Estimated Study Completion Date: October 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Biological: 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.
Other: Best Supportive Care
Patients will be randomised 2:1 to Arm A or Arm B and will receive best supportive care as needed.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01387555

  Hide Study Locations
Locations
United States, California
Moores University of California San Diego Cancer Center
La Jolla, California, United States, 92093
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
California Pacific Medical Center
San Francisco, California, United States
Stanford Hospital and Clinics
Stanford, California, United States
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States
United States, Montana
Billings Clinic
Billings, Montana, United States
United States, New Jersey
Saint Joseph's Hospital
Paterson, New Jersey, United States
United States, New York
Montefiore Medical Center
Bronx, New York, United States
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
United States, Texas
The Methodist Hospital Department of Surgery
Houston, Texas, United States, 77030
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada
Canada, Ontario
Juravinski Cancer Centre
Hamilton, Ontario, Canada
Ottawa Hopsital Research Institute
Ottawa, Ontario, Canada
France
Hôpitaux Universitaires de Strasbourg - Hôpital Civil
Strasbourg Cedex, Alsace, France, 67091
Centre Hospitalier Universitaire Hôpital Saint André
Bordeaux, Aquitaine, France, 33000
CHU d'Estaing
Clermont-Ferrand, Auvergne, France, 63003
Hôpital Saint Antoine, CPP Ile de France V
Paris, Ile-de-France, France, 75571
Hôpital Purpan
Toulouse, Midi-Pyrenees, France, 31059
Hôpital de la Croix Rousse
Lyon Cedex, Rhone-Alpes, France, 69317
Germany
Klinikum Rechts der Isar der Technischen Universität München
München, Bayern, Germany, 81675
Medizinische Hochschule Hannover
Hannover, Niedersachsen, Germany, 30625
Johannes Gutenberg-Universität Mainz
Mainz, Rheinland-Pfalz, Germany, 55131
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Korea, Republic of
Korea University Ansan Hospital
Ansan-si, Gyeonggi-Do, Korea, Republic of, 425-707
Kyungpook National University Hospital
Daegu, Korea, Republic of
Pusan National University Hospital
Pusan, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Samsung Medical Center
Seoul, Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of
Severance Hospital,Yonsei University Health System
Seoul, Korea, Republic of
Pusan National University Yangsan Hospital
Yangsan, Korea, Republic of
Taiwan
Taipei Veterans General Hospital
TPE, Taiwan
National Taiwan University Hospital
TPE, Taiwan
National Cheng-Kung University Hospital
TPE, Taiwan
Sponsors and Collaborators
Jennerex Biotherapeutics
Investigators
Study Director: James Burke, MD Jennerex Biotherapeutics
  More Information

Additional Information:
No publications provided

Responsible Party: Jennerex Biotherapeutics
ClinicalTrials.gov Identifier: NCT01387555     History of Changes
Other Study ID Numbers: JX594-HEP018
Study First Received: June 27, 2011
Last Updated: January 13, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Jennerex Biotherapeutics:
liver cancer
liver tumor
advanced hcc
hepatocellular cancer
Jennerex
HCC
Advanced HCC
sorafenib
sorafenib failure
sorafenib intolerant
Nexavar
Nexavar failure
JX594
oncolytic virus
vaccinia
viral therapy
JX
Biotherapeutics
HEP018
traverse
biologic
Pexa-Vec

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Liver Neoplasms
Vaccinia
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
DNA Virus Infections
Liver Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Poxviridae Infections
Virus Diseases
Sorafenib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014