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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

Phase 1
18 Years
Open (Enrolling)
Ovarian Neoplasms, Breast Neoplasms, Prostatic Neoplasms

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Trial Information

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

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.

Inclusion Criteria:

- Patients with stage III or IV ovarian cancer who have completed a course of
platinin-based cytotoxic therapy after debulking surgery with evidence of a complete
or partial response by radiological imaging. Patients with metastatic ovarian cancer
who have stable disease for greater than 3 months after completion of first-line

- Patients with stage IV breast cancer who have received at least 1 course of hormonal
or cytotoxic therapy for metastatic cancer. Patients must be off cytotoxic therapy
with stable disease or better for 3 months or greater duration. Patients may have
stable disease and still be on hormonal therapy.

- Patients with prostate cancer who have failed at least 1 course of an accepted
hormonal therapy. Specifically prostate cancer patients must have castrate
testosterone levels (< 50 ng/dl) and 2 PSA values higher than the previously
documented baseline at least 3 weeks apart or evidence of increases in measurable
disease. These patients may have received previous courses of cytotoxic chemotherapy
although chemotherapy naïve patients who are deemed not good candidates or who have
refused cytotoxic therapy will be eligible. These patients may remain on
anti-androgen therapy during the trial. Patients with evidence of progressive bone or
other metastases are acceptable.

- At least 8 weeks since previous courses of an investigational biologic therapy (i.e.
cancer vaccine) including active or passive immunotherapy.

- At least 30 days since localized surgery or radiotherapy.

- At least 30 days since initiation of a biphosphonate treatment.

- HLA A2 haplotype.

Exclusion Criteria:

- History of autoimmune disease, such as inflammatory bowel disease, systemic lupus
erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis. Patients
with a remote history (greater than five years) of thyroiditis are not excluded.

- Presence of an acute infection requiring antibiotics within 4 weeks of study entry or
a chronic infection such as: urinary tract infection, HIV, or antigen positive viral

- Previously resected brain metastases unless a CT or MRI scan of the brain shows no
metastasis within 1 month of receiving DPX-0907.

- Concurrent (within the last 5 years) second malignancy other than non-melanoma skin
cancer, cervical carcinoma in situ, or controlled bladder cancer.

- Acute or chronic skin disorders that will interfere with subcutaneous injection of
the vaccine or subsequent assessment of potential skin reactions.

- Serious intercurrent chronic or acute illness, such as cardiac disease (NYHA class
III or IV) or hepatic disease.

- Steroid therapy or other immunosuppressives, such as azathioprine or cyclosporin A,
unless steroids are discontinued 6 weeks prior to study.

- Allergies to any component of the vaccine.

- Inability to gain venous access.

- Previous splenectomy.

- Previous lymphadenectomy in both inguinal regions.

- Pregnant or nursing mothers.

- Medical or psychological impediment or active drug or alcohol use that might preclude
protocol compliance.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

On each vaccination day, 30 days after last vaccination and every month during the 6 month follow-up period

Safety Issue:


Principal Investigator

Michael Morse, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke University


United States: Food and Drug Administration

Study ID:




Start Date:

March 2010

Completion Date:

October 2011

Related Keywords:

  • Ovarian Neoplasms
  • Breast Neoplasms
  • Prostatic Neoplasms
  • vaccine
  • cancer
  • ovarian
  • breast
  • prostate
  • tumor
  • Immunotherapy
  • Breast Neoplasms
  • Neoplasms
  • Ovarian Neoplasms
  • Prostatic Neoplasms



Roswell Park Cancer InstituteBuffalo, New York  14263
Rush University Medical CenterChicago, Illinois  60612-3824
Duke University Medical CenterDurham, North Carolina  27710
Mary Crowley Cancer Research CenterDallas, Texas  75246
UPMC Cancer CenterPittsburgh, Pennsylvania  15232