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.
    1. 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)
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Contact us to find out if this trial is right for you.

Contact

Cancer Clinical Trials Office
650-498-7061

View on ClinicalTrials.gov