A Phase 2b Study of Modified Vaccinia Virus to Treat Patients Advanced Liver Cancer Who Failed Sorafenib
| Status: | Completed |
|---|---|
| Conditions: | Liver Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/30/2013 |
| Start Date: | August 2011 |
| End Date: | October 2014 |
| Contact: | Caro Unger |
| Email: | patient_inquiry@jennerex.com |
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
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.
Inclusion Criteria:
- Histologic or cytologic confirmation of primary hepatocellular carcinoma (HCC)
- 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
- ECOG performance status 0, 1 or 2
- Child-Pugh Class A; or Child-Pugh Class B7 without clinically significant ascites
Exclusion Criteria:
- Received systemic 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
- Hematocrit < 30% and/or Hemoglobin < 10 g/dL
- 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
We found this trial at
12
sites
Click here to add this to my saved trials
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
Click here to add this to my saved trials
Billings Clinic Based in Billings, Montana, Billings Clinic is a community-governed health care organization consisting...
Click here to add this to my saved trials
Gabrail Cancer Center Since 1990, Gabrail Cancer Center has built a national reputation for excellence...
Click here to add this to my saved trials
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
Click here to add this to my saved trials
University Hospitals of Cleveland The history of University Hospitals Case Medical Center is linked to...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
California Pacific Medical Center California Pacific Medical Center is one of the largest private, not-for-profit,...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials