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

NCT ID: NCT01636284

Last Updated: 2021-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-06-30

Brief Summary

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.

Detailed Description

This was a Phase 2a, two-staged, single-arm, open-label study in sorafenib-naïve patients with advanced HCC.

Patients received 5 weekly IV infusions of Pexa-Vec and could have continued to receive IV infusions of Pexa-Vec every 3 weeks until progressive disease (PD).

Conditions

Hepatocellular Carinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

JX-594 recombinant vaccina GM-CSF

JX-594 recombinant vaccina GM-CSF

Group Type: EXPERIMENTAL

JX-594 recombinant vaccina GM-CSF

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jennerex Biotherapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Burke, MD

Role: STUDY_DIRECTOR

Jennerex Biotherapeutics

Locations

Mayo Clinic

Scottsdale, Arizona, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Pusan National University Hospital

Pusan, , South Korea

Pusan National University Yangsan Hospital

Yangsan, , South Korea

University Clinic of Navarra

Pamplona, Navarre, Spain

Countries

United States; South Korea; Spain

Other Identifiers

JX594-IV-HEP021

Identifier Type: -

Identifier Source: org_study_id