Title Phase 1-2 Study of an Immunotherapeutic Vaccine, DPX-Survivac with Low Dose Cyclophosphamide in Patients with Surgically Operable or Advanced Stage Ovarian, Fallopian Tube or Peritoneal Cancer
Contact FS
Principal Investigator Adekunle Odunsi, MD PhD
Study Number 204411
PhaseI/II
Summary
The study is composed of two phases: Phase 1 and Phase 2. The purpose of the Phase 1 study is to test an investigational study drug (vaccine) called DPX-Survivac. In this study, the sponsor and investigators want to learn the safety profile of one dose level of study drug alone and two dose levels with cyclophospamide. In Phase 1 portion of this study, the safety profile and immune response following one cycle of 3 vaccinations will help the sponsor determine which dose level of the study drug with cyclophosphamide should be further investigated in the Phase 2 study. For Phase 1 portion, there are 10 study visits for a total of approximately 8 months in duration.
Eligibility
- Females age >= 18 years old of any racial or ethnic group
- Subjects with stage IIc-IV epithelial ovarian, fallopian tube, or peritoneal cancer who have completed adjuvant treatment consisting of up to 8 cycles of paclitaxel and carboplatin chemotherapy or other acceptable chemotherapy after initial debulking surgery with evidence of a complete or partial response by radiological imaging, are eligible
- Subjects with recurrent ovarian, fallopian tubal or peritoneal cancer who have clinical or radiologic evidence of complete or partial response or stable disease after completion of first-line chemotherapy for recurrent disease and are not suitable for additional cytotoxic therapy are eligible.
- Subjects undergoing concurrent chemotherapy, radiation therapy and immunotherapy are excluded.