Two-Arm Study of a DNA Vaccine Encoding Prostatic Acid Phosphatase (PAP) in Patients With Non-Metastatic Castrate-Resistant Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: pTVG-HP with rhGM-CSF; pTVG-HP with rhGM-CSF
Intervention description: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for 6 total doses, followed by pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. every 3 months until radiographic disease progression; pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for a minimum of 6 total doses, and continuing biweekly until evidence of T-cell immune response, and then following a booster schedule as defined by evidence of T-cell immune response.
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Vaccine; pTVG-HP; Prostate Cancer; Castrate Resistant

Summary:

      The investigators are trying to find new methods to treat prostate cancer. The approach is to
      try to enhance patients' own immune response against the cancer. In this study, the
      investigators will be testing the safety of a vaccine that may be able to help the body fight
      prostate cancer.

      The vaccine, called pTVG-HP, is a piece of DNA genetic material that contains genetic code
      for a protein that is made by the prostate gland, called prostatic acid phosphatase (PAP).
      The vaccine will be given together with a substance called an adjuvant. Adjuvants are
      typically given with vaccines and can improve the effect of the vaccine. The adjuvant that
      will be used in this study is called granulocyte-macrophage colony-stimulating factor
      (GM-CSF).

      The main purpose of this study is to find out whether the vaccine generates long-lived immune
      responses, and whether a better schedule of vaccination can be found by doing frequent
      laboratory testing for immune responses. The investigators also want to see if the vaccine
      stimulates any immune reaction against cancer cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Prostate Cancer

          -  Castrate Resistant Disease with rising PSA despite continuous treatment with
             orchiectomy or a LHRH agonist

          -  Rising PSA after treatment and withdrawal of anti-androgen

          -  Serum Testosterone <50ng/mL

          -  Normal organ function per laboratory tests

        Exclusion Criteria:

          -  No evidence of immunosuppression or on treatment with immunosuppressive agents

          -  Cannot have discontinued LHRH agonist treatment (if not previously treated by
             orchiectomy) within 6 months prior to study entry

          -  Must not be concurrently taking other medications or supplements with known hormonal
             effects (other than the LHRH agonist noted above).

          -  Cannot have any evidence for metastatic disease on bone or CT scan

          -  Unable or unwilling to undergo two leukapheresis procedure