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Primary Outcome Measures:
- To determine and compare time to recurrence (TTR) [ Time Frame: Participants will be followed for life. ] [ Designated as safety issue: No ]• To determine and compare time to recurrence (TTR) following the administration of bi-shRNAfurin and GMCSF autologous tumor cell (FANG™) vaccine in high risk patients with stage IIIc ovarian cancer NED following tumor debulking surgery and chemotherapy to standard of care post treatment observation.
Secondary Outcome Measures:
- Immune Function [ Time Frame: Blood will be collected at baseline, Months 2, 4, 6, 9, 12, 18 and EOT ] [ Designated as safety issue: Yes ]
- To identify and determine the effect of FANG™ autologous tumor cell vaccine on immune surrogate markers in this group of patients.
- To enlarge the safety database of FANG™ autologous tumor cell vaccine in patients with minimal disease.
| Estimated Enrollment: | 60 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | January 2016 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
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