Primary Outcome Measures:
Secondary Outcome Measures:
- Safety profile of JX-594 [ Time Frame: Safety assessments related to JX-594 up to 28 days after last IV infusion ] [ Designated as safety issue: No ]
Safety will be assessed by the number of adverse events (AEs) and serious adverse events (SAEs) up to 28 days after last JX-594 administration for an expected average of 52 weeks
- Time to progression [ Time Frame: From the earliest date of either documented progression or death of any cause, assessed up to 104 weeks ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: From date of final clinic visit until date of death, assessed up to 104 weeks ] [ Designated as safety issue: No ]
After radiographic progression, beginning other cancer therapy, or early withdrawal, patients and/or their specified contacts will continue to be contacted approximately every 4 weeks for survival and information on subsequent anti-cancer therapy including dose, duration, significant associated toxicities and efficacy.
Biological: 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.