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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)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Hepatocellular Carinoma

Thank you

Trial Information

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)


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor response

Outcome Description:

CT scans every six weeks until documented progression or date of death, whichever comes first, assessed up to 104 weeks.

Outcome Time Frame:

CT scans evaluated at Weeks 6, 12, 18, 24, 30, 36, 42, 48

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-IV-HEP021

NCT ID:

NCT01636284

Start Date:

June 2012

Completion Date:

April 2014

Related Keywords:

  • Hepatocellular Carinoma
  • Liver Cancer
  • HCC
  • first line HCC
  • Pexa-Vec
  • JX-594
  • Liver Neoplasms
  • Vaccinia
  • Carcinoma, Hepatocellular

Name

Location

University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Mayo ClinicScottsdale, Arizona