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
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Billings Clinic Based in Billings, Montana, Billings Clinic is a community-governed health care organization consisting...
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Gabrail Cancer Center Since 1990, Gabrail Cancer Center has built a national reputation for excellence...
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University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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University Hospitals of Cleveland The history of University Hospitals Case Medical Center is linked to...
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California Pacific Medical Center California Pacific Medical Center is one of the largest private, not-for-profit,...
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