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A Phase 2a Study of Modified Vaccinia Virus to Treat Sorafenib-naïve Advanced Liver Cancer (FLASH)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jennerex Biotherapeutics
ClinicalTrials.gov Identifier:
NCT01636284
First received: June 23, 2012
Last updated: April 9, 2013
Last verified: July 2012
History of Changes
  Purpose

This study is to determine how effectively JX-594 (Pexa-Vec) will prolong life in patients with advanced Hepatocellular Carcinoma (HCC) who have not been previously treated with sorafenib, and the safe administration of JX-594 in five weekly IV infusions.


Condition Intervention Phase
Hepatocellular Carinoma
 Biological: JX-594 recombinant vaccina GM-CSF
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single-Arm, Open-Label Phase 2 Study of JX 594 (Thymidine Kinase-Deactivated Vaccinia Virus Plus GM-CSF) Administered by Weekly Intravenous (IV) Infusions in Sorafenib-naïve Patients With Advanced Hepatocellular Carcinoma (HCC)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Liver Cancer
U.S. FDA Resources

Further study details as provided by Jennerex Biotherapeutics:

Primary Outcome Measures:
  • Tumor response [ Time Frame: CT scans evaluated at Weeks 6, 12, 18, 24, 30, 36, 42, 48 ] [ Designated as safety issue: No ]
    CT scans every six weeks until documented progression or date of death, whichever comes first, assessed up to 104 weeks.


Secondary Outcome Measures:
  • Safety profile of JX-594 [ Time Frame: Safety assessments related to JX-594 up to 28 days after last IV infusion ] [ Designated as safety issue: No ]
    Safety will be assessed by the number of adverse events (AEs) and serious adverse events (SAEs) up to 28 days after last JX-594 administration for an expected average of 52 weeks

  • Time to progression [ Time Frame: From the earliest date of either documented progression or death of any cause, assessed up to 104 weeks ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: From date of final clinic visit until date of death, assessed up to 104 weeks ] [ Designated as safety issue: No ]
    After radiographic progression, beginning other cancer therapy, or early withdrawal, patients and/or their specified contacts will continue to be contacted approximately every 4 weeks for survival and information on subsequent anti-cancer therapy including dose, duration, significant associated toxicities and efficacy.


Estimated Enrollment: 21
Study Start Date: June 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: JX-594 recombinant vaccina GM-CSF
    Enrolled patients will receive 5 weekly IV infusions on Days 1, 8, 15, 22, and 29. After Day 43, if their disease has improved or remained stable and they have not started other cancer therapy, they may be able to continue to receive JX-594 via IV infusion every three weeks. This treatment extension may continue until radiologic progressive disease, initiation of other cancer therapy, or patient withdrawal.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

KEY Inclusion Criteria:

  • Histologic or cytologic confirmation of advanced primary hepatocellular carcinoma (HCC)
  • Measurable tumor (at least one tumor with ≥1 cm LD of contrast-enhancement during the arterial phase on CT scanning)
  • ECOG performance status 0, 1 or 2
  • Child-Pugh Class A; or Child-Pugh Class B7 without clinically significant ascites
  • Platelet count ≥50,000 plts/mm3
  • WBC count ≥2,000 cells/mm3 and ≤50,000 cells/mm3
  • Hemoglobin ≥10 g/dL
  • Adequate liver function

KEY Exclusion Criteria:

  • Received sorafenib as previous treatment for HCC for more than 14 days
  • History of severe exfoliative skin condition (e.g., eczema or atopic dermatitis requiring systemic therapy for > 4 weeks)
  • Prior treatment with JX-594
  • 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
  • Significant bleeding event within the last 12 months.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01636284

Locations
United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85259
United States, Texas
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Korea, Republic of
Pusan National University Hospital
Pusan, Korea, Republic of
Pusan National University Yangsan Hospital
Yangsan, Korea, Republic of
Spain
University Clinic of Navarra
Navarra, Spain
Sponsors and Collaborators
Jennerex Biotherapeutics
Investigators
Study Director: James Burke, MD Jennerex Biotherapeutics
  More Information

No publications provided

Responsible Party: Jennerex Biotherapeutics
ClinicalTrials.gov Identifier: NCT01636284     History of Changes
Other Study ID Numbers: JX594-IV-HEP021
Study First Received: June 23, 2012
Last Updated: April 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Jennerex Biotherapeutics:
Liver Cancer
HCC
first line HCC
Pexa-Vec
JX-594

Additional relevant MeSH terms:
Liver Neoplasms
Vaccinia
Carcinoma, Hepatocellular
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Poxviridae Infections
DNA Virus Infections
Virus Diseases
 Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013