A Phase I Study of Two Different Doses of the Subcutaneous Administration of an Immunotherapeutic Vaccine, DPX-0907 in Advanced Stage Patients With Ovarian, Breast or Prostate Cancer
Epithelial ovarian cancer has a high mortality rate even among those who obtain complete
remission after surgery and chemotherapy. In prostate cancer, hormonal therapies including
androgen ablation may control the disease for variable lengths of time but progression will
invariably occur. There is also a high rate of relapse in breast cancer patients who have
four or more positive axillary lymph nodes and in cases of resected metastatic disease.
Immune therapies such as therapeutic vaccination may prolong remissions in these cancers.
Many different therapeutic vaccines have been evaluated in these diseases in phase 1, 2 and
even phase 3 trials. Much has been learned about the principals of applying immune-based
therapies and specifically the types of patients that may be most likely to mount an
effective immune response. Cancer vaccines may have their greatest impact earlier in the
disease course or in situations with minimal residual disease. Most recently an overall
survival benefit was documented in prostate cancer patients with an immunotherapy based
vaccine.
ImmunoVaccine Technologies Inc. (IVT) is developing a therapeutic vaccine against various
solid cancers based on a patented vaccine delivery and enhancement platform. The antigens
included in DPX-0907 were identified using an innovative antigen discovery platform to
identify proprietary signature antigens actually presented on the surface of tumor cells and
therefore capable of stimulating a cellular immune response in the patient. One or more of
the peptide antigens are expected to be expressed in the types of tumors included in this
trial. The peptide antigens proposed for DPX-0907 have been previously included in a phase I
study in a different vaccine formulation at Duke University. No vaccine-induced autoimmune
events were reported. These encouraging results suggest that the autoimmune potential of
these cancer-specific peptide antigens is limited. IVT's DepoVax™ (DPX) lipid-based
formulation was designed to enhance the speed, strength and duration of the cellular immune
response. This formulation in combination with tumor targeting antigens has produced
favorable safety and cellular immune responses in preclinical studies. These parameters
will be studied in this phase I trial.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the safety profile of two different doses of subcutaneously administered DPX-0907. Safety assessments will be based on reported adverse events and the results of vital sign measurements, physical examinations, and clinical laboratory tests.
On each vaccination day, 30 days after last vaccination and every month during the 6 month follow-up period
Yes
Michael Morse, MD
Study Chair
Duke University
United States: Food and Drug Administration
ONC-DPX-0907-01
NCT01095848
March 2010
October 2011
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
Duke University Medical Center | Durham, North Carolina 27710 |
Mary Crowley Cancer Research Center | Dallas, Texas 75246 |
UPMC Cancer Center | Pittsburgh, Pennsylvania 15232 |