Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Hepatocellular Carcinoma, Liver Cancer, HCC

Thank you

Trial Information

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


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)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Survival

Outcome Description:

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.

Outcome Time Frame:

CT scan every six weeks until progression or death, assessed up to 21 months

Safety Issue:

No

Principal Investigator

James Burke, MD

Investigator Role:

Study Director

Investigator Affiliation:

Jennerex Biotherapeutics

Authority:

United States: Food and Drug Administration

Study ID:

JX594-HEP018

NCT ID:

NCT01387555

Start Date:

August 2011

Completion Date:

October 2014

Related Keywords:

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

Name

Location

Chao Family Comprehensive Cancer CenterOrange, California  92868
Montefiore Medical CenterBronx, New York  10467-2490
University of Chicago Medical CenterChicago, Illinois  60637
California Pacific Medical CenterSan Francisco, California  94115
Gabrail Cancer CenterCanton, Ohio  44718
Stanford Hospital and ClinicsStanford, California  94305
Billings ClinicBillings, Montana  59107-7000
Moores University of California San Diego Cancer CenterLA Jolla, California  92093
University Hospitals Case Medical CenterCleveland, Ohio  44106
The Methodist Hospital Department of SurgeryHouston, Texas  77030
Saint Joseph's HospitalPaterson, New Jersey