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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


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

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine safety and tolerability of intravenous infusion of JX-594 followed by intratumoral injections with JX-594 prior to standard sorafenib therapy

Outcome Description:

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).

Outcome Time Frame:

Safety evaluations through 28 days after last dose of JX-594

Safety Issue:

Yes

Principal Investigator

David H Kirn, MD

Investigator Role:

Study Director

Investigator Affiliation:

Jennerex Biotherapeutics

Authority:

South Korea: Korea Food and Drug Administration (KFDA)

Study ID:

JX594-HEP016

NCT ID:

NCT01171651

Start Date:

August 2009

Completion Date:

August 2013

Related Keywords:

  • Carcinoma, Hepatocellular
  • Vaccinia
  • Vaccinia Virus
  • JX-594
  • Jennerex
  • Primary Hepatocellular Carcinoma
  • Primary Liver Cancer
  • Liver Cancer
  • Sorafenib
  • Nexavar
  • Pexa-Vec
  • Carcinoma
  • Vaccinia
  • Carcinoma, Hepatocellular

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