A Study of Recombinant Vaccinia Virus Prior to Sorafenib to Treat Unresectable Primary Hepatocellular Carcinoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Jennerex Biotherapeutics.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Jennerex Biotherapeutics
ClinicalTrials.gov Identifier:
NCT01171651
First received: July 26, 2010
Last updated: January 13, 2014
Last verified: June 2011

July 26, 2010
January 13, 2014
August 2009
February 2013   (final data collection date for primary outcome measure)
Determine safety and tolerability of intravenous infusion of JX-594 followed by intratumoral injections with JX-594 prior to standard sorafenib therapy [ Time Frame: Safety evaluations through 28 days after last dose of JX-594 ] [ Designated as safety issue: Yes ]
Adverse events will be collected and assessed to assess safety and tolerability through 28 days after last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Same as current
Complete list of historical versions of study NCT01171651 on ClinicalTrials.gov Archive Site
  • Determine Disease Control Rate (DCR) at 12 weeks [ Time Frame: Disease control and response assessment at 12 weeks from first JX-594 dose ] [ Designated as safety issue: No ]
    DCR: confirmed complete response, partial response or stable disease based on modified RECIST and/or Choi response criteria
  • Determine radiographic response rate [ Time Frame: Periodically throughout study participation (average of up to 1 year) ] [ Designated as safety issue: No ]
    Response rate evaluation based on modified RECIST and/or Choi response criteria
  • Determine overall survival time [ Time Frame: Ongoing (average of 1 year) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Recombinant Vaccinia Virus Prior to Sorafenib to Treat Unresectable Primary Hepatocellular Carcinoma
A Phase 2 Open-Label Pilot Safety Study of JX-594 (Vaccinia GM-CSF/Thymidine Kinase-Deactivated Virus) Administered by IV Infusion Followed by Intratumoral Injection Prior to Standard Sorafenib Treatment in Patients With Unresectable Primary Hepatocellular Carcinoma

The purpose of this pilot safety study is to evaluate the safety and tolerability of JX-594 (Pexa-Vec) administered intravenously and intratumorally prior to standard sorafenib therapy.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma, Hepatocellular
Drug: JX-594 followed by sorafenib
Patients will receive a total dose of 1e9 per treatment starting with one IV dose on Day 1 and injected intratumorally in 1-5 intrahepatic tumors on Day 8 and 22. Starting on Day 25 (3 days after the final JX-594 dose) patients will initiate oral sorafenib therapy twice daily according to standard approved guidelines. An optional maintenance JX-594 dose may be given intratumorally at Week 12 (sorafenib briefly interrupted).
Experimental: JX-594 followed by sorafenib
1e9 pfu (plaque-forming units) total JX-594 dose on each of up to four (4) JX-594 treatment days. Sorafenib is initiated after 3 JX-594 treatments and briefly interrupted if an optional 4th JX-594 treatment is given.
Intervention: Drug: JX-594 followed by sorafenib
Breitbach CJ, Arulanandam R, De Silva N, Thorne SH, Patt R, Daneshmand M, Moon A, Ilkow C, Burke J, Hwang TH, Heo J, Cho M, Chen H, Angarita FA, Addison C, McCart JA, Bell JC, Kirn DH. Oncolytic vaccinia virus disrupts tumor-associated vasculature in humans. Cancer Res. 2013 Feb 15;73(4):1265-75. doi: 10.1158/0008-5472.CAN-12-2687. Epub 2013 Feb 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
25
June 2014
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histological confirmation or clinical/laboratory diagnosis of primary hepatocellular carcinoma (HCC)
  • Cancer is not surgically resectable for cure
  • Child Pugh A or B
  • Performance Score: KPS score of ≥ 70
  • Platelet count ≥ 50,000 plts/mm3
  • Total bilirubin ≤ 2.5 x ULN
  • AST, ALT < 5.0 x ULN
  • Acceptable coagulation status: INR ≤ 1.5 x ULN
  • Acceptable kidney function: Serum creatinine < 2.0 mg/dL
  • Sorafenib naive or refractory to sorafenib therapy Tumor Status: At least one intrahepatic tumor, and at least ≥50% of the total intrahepatic viable tumor mass, measurable by CT and injectable under imaging-guidance (note: injected and/or viable tumors must be previously untreated or ≥20% increase in size since preceding local-regional treatment).

Exclusion Criteria:

  • Known contraindications to sorafenib
  • Pregnant or nursing an infant
  • Significant immunodeficiency due to underlying illness (e.g. hematological malignancies, congenital immunodeficiencies and/or HIV infection/AIDS) and/or medication (e.g. high-dose systemic corticosteroids)
  • History of exfoliative skin condition (e.g. severe eczema, ectopic dermatitis, or similar skin disorder) that at some stage has required systemic therapy
  • Clinically significant and/or rapidly accumulating ascites, peri-cardial and/or pleural effusions
  • Severe or unstable cardiac disease
  • Current, known CNS malignancy
  • Use of anti-platelet or anti-coagulation medication
  • Use of the following anti-viral agents: ribavirin, adefovir, cidofovir (within 7 days prior to the first treatment), and PEG-IFN (within 14 days prior to the first treatment).
  • Patients with household contacts who meet any of these criteria unless alternate living arrangements can be made during the patient's active dosing period and for 7 days following the last dose of study medication:
  • Pregnant or nursing an infant
  • Children < 12 months old
  • History of exfoliative skin condition that at some stage has required systemic therapy
  • Significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01171651
JX594-HEP016
No
Jennerex Biotherapeutics
Jennerex Biotherapeutics
Not Provided
Study Director: David H Kirn, MD Jennerex Biotherapeutics
Jennerex Biotherapeutics
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP