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A Phase 2b Study of Modified Vaccinia Virus to Treat Patients Advanced Liver Cancer Who Failed Sorafenib (TRAVERSE)

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: NCT01387555
Recruitment Status : Completed
First Posted : July 4, 2011
Last Update Posted : March 11, 2015
Sponsor:
Information provided by (Responsible Party):
Jennerex Biotherapeutics

Study Description
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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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2008
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Viral Infections

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Survival [ Time Frame: CT scan every six weeks until progression or death, assessed up to 21 months ]
    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 :
  1. Time to Tumor Progression [ Time Frame: CT scan every six weeks until progression or death, assessed up to 21 months ]
    Determine time-to-tumor-progression (TTP) for Arm A compared with Arm B based on mRECIST for HCC.

  2. Quality of Life [ Time Frame: assessed up to 21 months (average) ]
    Determine the Quality of Life (QoL) of patients treated in Arm A compared with Arm B.

  3. Tumor Response [ Time Frame: CT scan every 6 weeks until progression or death, assessed up to 21 months (average) ]
    Determine tumor response based on mRECIST for HCC of Arm A versus Arm B

  4. Safety profile of JX594 [ Time Frame: assessed up to 21 months (average) ]
    Safety will be assessed by the number of adverse events (AEs) and serious adverse events (SAEs)

  5. Time-to-symptomatic-progression [ Time Frame: assessed up to 21 months (average) ]
    Determine time to progression of Arm A compared to Arm B.


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

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
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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): NCT01387555


Locations
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Sponsors and Collaborators
Jennerex Biotherapeutics
Investigators
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Study Director: James Burke, 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: NCT01387555    
Other Study ID Numbers: JX594-HEP018
First Posted: July 4, 2011    Key Record Dates
Last Update Posted: March 11, 2015
Last Verified: March 2015
Keywords provided by Jennerex Biotherapeutics:
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
Additional relevant MeSH terms:
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Vaccinia
Carcinoma
Carcinoma, Hepatocellular
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Poxviridae Infections
DNA Virus Infections
Virus Diseases
Infections