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

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
therapy.

- 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
hepatitis.

- 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.