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

Hepatocellular Carcinoma Clinical Trial

— TRAVERSE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01387555
• Other study ID #: JX594-HEP018
• Status: Completed
• Phase: Phase 2
• First received: June 27, 2011
• Last updated: March 10, 2015
• Start date: December 2008
• Est. completion date: December 2011

Study information

• Verified date: March 2015
• Source: Jennerex Biotherapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• HCC
• Hepatocellular Carcinoma
• Liver Cancer
• Liver Neoplasms
• Vaccinia

Intervention

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.

Other:
• Best Supportive Care
Patients will be randomised 2:1 to Arm A or Arm B and will receive best supportive care as needed.

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta
Canada	Juravinski Cancer Centre	Hamilton	Ontario
Canada	Ottawa Hopsital Research Institute	Ottawa	Ontario
Canada	University of British Columbia	Vancouver	British Columbia
France	Centre Hospitalier Universitaire Hôpital Saint André	Bordeaux	Aquitaine
France	CHU d'Estaing	Clermont-Ferrand	Auvergne
France	Hôpital de la Croix Rousse	Lyon Cedex	Rhone-Alpes
France	Hôpital Saint Antoine, CPP Ile de France V	Paris	Ile-de-France
France	Hôpitaux Universitaires de Strasbourg - Hôpital Civil	Strasbourg Cedex	Alsace
France	Hôpital Purpan	Toulouse	Midi-Pyrenees
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover	Niedersachsen
Germany	Johannes Gutenberg-Universität Mainz	Mainz	Rheinland-Pfalz
Germany	Klinikum Rechts der Isar der Technischen Universität München	München	Bayern
Hong Kong	Queen Mary Hospital	Hong Kong
Korea, Republic of	Korea University Ansan Hospital	Ansan-si	Gyeonggi-Do
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	Pusan National University Hospital	Pusan
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital,Yonsei University Health System	Seoul
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan
Taiwan	National Cheng-Kung University Hospital	TPE
Taiwan	National Taiwan University Hospital	TPE
Taiwan	Taipei Veterans General Hospital	TPE
United States	Billings Clinic	Billings	Montana
United States	Montefiore Medical Center	Bronx	New York
United States	Gabrail Cancer Center	Canton	Ohio
United States	University of Chicago Medical Center	Chicago	Illinois
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	The Methodist Hospital Department of Surgery	Houston	Texas
United States	Moores University of California San Diego Cancer Center	La Jolla	California
United States	Chao Family Comprehensive Cancer Center	Orange	California
United States	Saint Joseph's Hospital	Paterson	New Jersey
United States	California Pacific Medical Center	San Francisco	California
United States	Stanford Hospital and Clinics	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Jennerex Biotherapeutics

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Hong Kong,  Korea, Republic of,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	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.	CT scan every six weeks until progression or death, assessed up to 21 months	No
Secondary	Time to Tumor Progression	Determine time-to-tumor-progression (TTP) for Arm A compared with Arm B based on mRECIST for HCC.	CT scan every six weeks until progression or death, assessed up to 21 months	No
Secondary	Quality of Life	Determine the Quality of Life (QoL) of patients treated in Arm A compared with Arm B.	assessed up to 21 months (average)	No
Secondary	Tumor Response	Determine tumor response based on mRECIST for HCC of Arm A versus Arm B	CT scan every 6 weeks until progression or death, assessed up to 21 months (average)	No
Secondary	Safety profile of JX594	Safety will be assessed by the number of adverse events (AEs) and serious adverse events (SAEs)	assessed up to 21 months (average)	Yes
Secondary	Time-to-symptomatic-progression	Determine time to progression of Arm A compared to Arm B.	assessed up to 21 months (average)	No

External Links

•   Sponsor Website