A Phase 2b Study of Modified Vaccinia Virus to Treat Patients Advanced Liver Cancer Who Failed Sorafenib (TRAVERSE)
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|ClinicalTrials.gov Identifier: NCT01387555|
Recruitment Status : Completed
First Posted : July 4, 2011
Last Update Posted : March 11, 2015
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma Liver Cancer HCC||Biological: JX-594 recombinant vaccina GM-CSF Other: Best Supportive Care||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||129 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
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.
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.
- Survival [ Time Frame: CT scan every six weeks until progression or death, assessed up to 21 months ]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.
- Time to Tumor Progression [ Time Frame: CT scan every six weeks until progression or death, assessed up to 21 months ]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) ]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) ]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) ]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) ]Determine time to progression of Arm A compared to Arm B.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01387555
|Study Director:||James Burke, MD||Jennerex Biotherapeutics|