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

Trial ID or NCT#

NCT01387555

Status

not recruiting iconNOT RECRUITING

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.

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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)

Investigator(s)

Nishita Kothary, MD
Nishita Kothary, MD
Interventional radiologist
Professor of Radiology (Interventional Radiology)
Aya Kamaya, MD
Aya Kamaya, MD
Radiologist
Professor of Radiology (Body Imaging)
Gloria Hwang, MD
Gloria Hwang, MD
Interventional radiologist
Clinical Professor, Radiology
David Hovsepian, MD
David Hovsepian, MD
Interventional radiologist, Radiologist
Clinical Professor, Radiology
John D. Louie, MD
John D. Louie, MD
Interventional radiologist
Clinical Professor, Radiology

Contact us to find out if this trial is right for you.

CONTACT

Cancer Clinical Trials Office
(650) 498-7061