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
The standard treatment for all ovarian cancer is aggressive debulking surgery followed by
chemotherapy. Ovarian carcinoma is one of the most chemosensitive solid tumors and early
stage patients are most responsive to treatment. However, despite improvements to the
standard treatment over the past three decades, almost all patients with advanced stage
disease at presentation will relapse, with an average progression free survival of 16-18
months. When residual or recurrent disease manifests itself, resistance to chemotherapy
often prohibits further curative therapy. Therefore, there are still significant unmet needs
in treating ovarian cancer patients.
Treatment with DPX-Survivac is for patients with late-stage ovarian, fallopian tube, or
peritoneal cancer who have completed initial chemotherapy treatment and successful debulking
surgery. The phase 1 dose finding study will administer 3 doses of DPX-Survivac with or
without accompanying low dose oral cyclophosphamide. The phase 2, placebo controlled, study
will administer DPX-Survivac or placebo with accompanying low dose cyclophosphamide or
placebo.
PHASE 1
- non-randomized, open-label, dose-finding study
- at least 15 subjects
- three safety cohorts (listed in the table above)
- safety and immunogenicity findings will determine dosage for phase 2
PHASE 2
- 2:1 randomized, double-blinded, placebo controlled study
- approximately 250 subjects
- two arms (1) Experimental: DPX-Survivac (injection) and low dose cyclophosphamide
(oral) and (2) Control: placebo injection and oral placebo
Interventional
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
PHASE 1: Number of reported adverse events
The number of adverse events along with the results of vital sign measurements, physical examinations, and clinical laboratory tests will be used to determine the safety profile of subcutaneous administration of DPX-Survivac.
Until 6 month follow up
Yes
United States: Food and Drug Administration
ONC-DPX-Survivac-01
NCT01416038
December 2011
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Winthrop University Hospital | Mineola, New York 11501 |
Oregon Health & Science University | Portland, Oregon 97201 |
Duke University Medical Center | Durham, North Carolina 27710 |
Mary Crowley Cancer Research Center | Dallas, Texas 75246 |