A Phase 2b Study of Modified Vaccinia Virus to Treat Patients Advanced Liver Cancer Who Failed Sorafenib (TRAVERSE)
This study is ongoing, but not recruiting participants.
Sponsor:
Jennerex Biotherapeutics
Information provided by (Responsible Party):
Jennerex Biotherapeutics
ClinicalTrials.gov Identifier:
NCT01387555
First received: June 27, 2011
Last updated: May 15, 2013
Last verified: July 2012
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Purpose
This study is to determine whether JX-594 (Pexa-Vec) plus best supportive care is more effective in improving survival than best supportive care in patients with advanced Hepatocellular Carcinoma (HCC) who have failed sorafenib.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatocellular Carcinoma Liver Cancer HCC |
Biological: JX-594 recombinant vaccina GM-CSF Other: Best Supportive Care |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 2b Randomized Trial of JX-594 (Vaccinia GM-CSF / TK-deactivated Virus) Plus Best Supportive Care Versus Best Supportive Care in Patients With Advanced Hepatocellular Carcinoma Who Have Failed Sorafenib Treatment |
Resource links provided by NLM:
Further study details as provided by Jennerex Biotherapeutics:
Primary Outcome Measures:
- Survival [ Time Frame: CT scan every six weeks until progression or death, assessed up to 21 months ] [ Designated as safety issue: No ]Determine overall survival for patients receiving JX-594 plus best supportive care (Arm A) compared with those patients receiving best supportive care (Arm B) in patients with advanced hepatocellular carcinoma (HCC) who have failed sorafenib treatment.
Secondary Outcome Measures:
- Time to Tumor Progression [ Time Frame: CT scan every six weeks until progression or death, assessed up to 21 months ] [ Designated as safety issue: No ]Determine time-to-tumor-progression (TTP) for Arm A compared with Arm B based on mRECIST for HCC.
- Quality of Life [ Time Frame: assessed up to 21 months (average) ] [ Designated as safety issue: No ]Determine the Quality of Life (QoL) of patients treated in Arm A compared with Arm B.
- Tumor Response [ Time Frame: CT scan every 6 weeks until progression or death, assessed up to 21 months (average) ] [ Designated as safety issue: No ]Determine tumor response based on mRECIST for HCC of Arm A versus Arm B
- Safety profile of JX594 [ Time Frame: assessed up to 21 months (average) ] [ Designated as safety issue: Yes ]Safety will be assessed by the number of adverse events (AEs) and serious adverse events (SAEs)
- Time-to-symptomatic-progression [ Time Frame: assessed up to 21 months (average) ] [ Designated as safety issue: No ]Determine time to progression of Arm A compared to Arm B.
| Estimated Enrollment: | 120 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm A
Patients on Arm A will receive 1 e9 pfu (plaque forming units) total dose of JX-594 (Vaccinia GM-CSF / TK-deactivated Virus) on each of six (6) treatments over 18 weeks.
|
Biological: JX-594 recombinant vaccina GM-CSF
Patients will be randomised 2:1 to Arm A or Arm B and will receive 6 treatments on days 1, 8, 22, week 6, week 12, and week 18 plus best supportive care as needed.
|
|
Arm B
Patients on the control arm (Arm B) will have best supportive care over 18 weeks.
|
Other: Best Supportive Care
Patients will be randomised 2:1 to Arm A or Arm B and will receive best supportive care as needed.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
KEY Inclusion Criteria:
- Diagnosis of primary HCC by tissue biopsy (histological/cytological diagnosis), or clinical diagnosis
- Previously treated with sorafenib for ≥ 14 days and has discontinued sorafenib treatment at least 14 days prior to randomization due to either intolerance or radiographic progression NOTE: Sorafenib is NOT required to be the most recent treatment received for HCC
- ECOG performance status 0, 1 or 2
- Child-Pugh Class A; or Child-Pugh Class B7 without clinically significant ascites
- Hematocrit ≥30% or Hemoglobin ≥10 g/dL
- Tumor status: Measurable viable tumor in the liver and injectable under imaging-guidance; At least one tumor in the liver that has not received prior local-regional treatment OR that has exhibited >25% growth in viable tumor size since prior local-regional treatment.
KEY Exclusion Criteria:
- Received sorafenib within 14 days prior to randomization
- Received systemic anti-cancer therapy other than sorafenib within 28 days of randomization
- Prior treatment with JX-594
- Platelet count < 50,000 PLT/ mm3
- Total white blood cell count < 2,000 cells/mm3
- Prior or planned organ transplant
- 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
- History of inflammatory skin condition (e.g., eczema requiring previous treatment, atopic dermatitis)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01387555
Show 38 Study Locations
Show 38 Study LocationsSponsors and Collaborators
Jennerex Biotherapeutics
Investigators
| Study Director: | James Burke, MD | Jennerex Biotherapeutics |
More Information
Additional Information:
No publications provided
| Responsible Party: | Jennerex Biotherapeutics |
| ClinicalTrials.gov Identifier: | NCT01387555 History of Changes |
| Other Study ID Numbers: | JX594-HEP018 |
| Study First Received: | June 27, 2011 |
| Last Updated: | May 15, 2013 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada |
Keywords provided by Jennerex Biotherapeutics:
|
liver cancer liver tumor advanced hcc hepatocellular cancer Jennerex HCC Advanced HCC sorafenib sorafenib failure sorafenib intolerant Nexavar |
Nexavar failure JX594 oncolytic virus vaccinia viral therapy JX Biotherapeutics HEP018 traverse biologic Pexa-Vec |
Additional relevant MeSH terms:
|
Carcinoma Liver Neoplasms Vaccinia Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |
Poxviridae Infections DNA Virus Infections Virus Diseases Adenocarcinoma Sorafenib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013