Multi-Epitope TARP Peptide Autologous Dendritic Cell Vaccination in Men With Stage D0 Prostate Cancer
Condition: Prostatic Neoplasms; Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Autologus elutriated monocyte placebo vaccine; Multi-epitope (ME) T-cell receptor g alternate reading frame protein (TARP) vaccine
Intervention description: 20x10^6 viable cells/dose at weeks 3, 6, 9, 12, 15 and 24; 20x10^6 viable cells/dose at weeks 3, 6, 9, 12, 15 and 24
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 7.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Dendritic Cell Vaccine; Multi Epitope Tarp Peptide; Autolougous Dendritic Cell; D0 Prostate Cancer; Vaccine Therapy

Summary:

      Background:

      - Men who continue to have an elevated or rising prostate specific antigen (PSA) level after
      their primary prostate cancer treatment are at increased risk for their cancer to progress.
      The time it takes to progress is highly variable. One way to predict this progression is
      based on the change in PSA levels over time. This is called the PSA doubling time (PSADT).
      Researchers want to test a vaccine on men with Stage D0 prostate cancer. Stage D0 means the
      PSA has become detectable again or has started to rise after primary treatment, but has not
      spread to other organs.

      Objectives:

      - To test a vaccines effectiveness on the rate of PSA increase using PSADT and tumor growth
      rates.

      Eligibility:

      - Men with Stage D0 prostate cancer with a PSADT between 3 and 15 months.

      Design:

        -  Participants will be screened with blood tests, scans, physical exam, and medical
           history. Their prostate cancer will be confirmed.

        -  Participants will undergo apheresis. Blood will be removed with a needle from one arm. A
           machine will separate the white blood cells. The blood, minus the white cells, will be
           returned through a needle in the other arm.

        -  Participants will have 14 visits. At each visit, they will have a physical exam and
           blood tests. They will discuss any side effects.

        -  Participants will get injections of either the vaccine or placebo at weeks 3, 6, 9, 12,
           15, and 24. Both will be made from the participants own cells.

        -  Participants will be selected randomly to receive either active vaccine or placebo. For
           every two participants assigned to active vaccine, one participant will be assigned to
           placebo vaccine.

        -  Participants will get a Vaccine Report Card to to complete after receiving vaccine.

        -  The study lasts 96 weeks.
    

Eligibility criteria:

        -INCLUSION CRITERIA:

          1. Males greater than or equal to 18 years of age with histologically confirmed
             adenocarcinoma of the prostate. Histology confirmation must be documented with a
             formal pathology report. Notes from an outside physician describing the pathologic
             findings (based on a prior review of the full pathology report) may be used if unable
             to obtain the original pathology report. This will eliminate the need for an
             additional invasive tissue biopsy.

          2. Must have completed and recovered from all prior definitive therapy (surgery,
             brachytherapy, cryotherapy or radiotherapy) for the primary tumor, or other
             definitiveintent local therapy.

          3. Stage D0 disease with documented biochemical progression documented by rising prostate
             specific-antigen (PSA) and no evidence of metastatic disease by physical examination,
             computed tomography (CT) scan or bone scan.

          4. Prostate specific-antigen doubling time (PSADT) greater than or equal to 3 months and
             less than or equal to 15 months:

               -  Patients must have greater than or equal to 3 PSA measurements over greater than
                  or equal to 3 months.

               -  The interval between PSA measurements must be greater than or equal to 4 weeks.

          5. For patients following definitive radiation therapy or cryotherapy: a rise in PSA of >
             2ng/mL above the nadir (per Radiation Therapy Oncology Group (RTOG)-American Society
             for Therapeutic Radiology and Oncology (ASTRO) consensus criteria).

          6. For patients following radical prostatectomy: 2 absolute PSA values > 0.2ng/ml.

          7. Non-castrate level of testosterone: greater than or equal to 50 ng/dL (prior
             antiandrogen treatment (ADT) allowed; must be greater than or equal to 6 months since
             last dose of ADT).

          8. Performance Status: Eastern Cooperative Oncology Group (ECOG) 0-1.

          9. Hemoglobin greater than or equal to 9.0 gm/dL, white blood cell (WBC) greater than or
             equal to 2,500/mm(3), absolute lymphocyte count (ALC) greater than or equal to 500/
             mm(3), absolute neutrophil count (ANC) greater than or equal to 1,000/mm(3) platelet
             count greater than or equal to 75,000/mm(3), and prothrombin time (PT)/Partial
             thromboplastin time (PTT)PTT less than or equal to 1.5 times upper limit of normal
             (ULN) unless receiving clinically indicated anticoagulant therapy; serum
             glutamic-pyruvic transaminase (SGPT)/Serum glutamic oxaloacetic transaminase (SGOT)
             less than or equal to 3 times ULN, total bilirubin less than or equal to 1.5 times
             ULN; creatinine less than or equal to 1.5 times ULN and estimated GFR (eGFR) greater
             than or equal to 60 ml/min.

         10. Hepatitis B and C negative (unless the result is consistent with prior vaccination or
             prior infection with full recovery); human immunodeficiency virus (HIV) negative.

         11. No use of investigational agents within 4 weeks of study enrollment or use of
             immunosuppressive or immunomodulating agents within 8 weeks of study entry.

         12. No other concurrent anticancer therapy or prior prostate cancer vaccines expressing
             T-cell receptor alternate reading frame protein (TARP).

         13. No alternative medications or nutriceuticals known to alter PSA (e.g. phytoestrogens
             and saw palmetto). Note: patients receiving medications for urinary symptoms such as
             Flomax or 5-alpha reductase inhibitors (finasteride and dutasteride) on a chronic
             stable dose for at least 3 months prior to study enrollment are allowed.

        EXCLUSION CRITERIA:

          1. Patients with an active second malignancy other than adequately treated squamous or
             basal cell carcinoma of the skin.

          2. Patients with active infection.

          3. Patients on immunosuppressive therapy including:

             - Systemic corticosteroid therapy for any reason. Patients receiving inhaled or
             topical corticosteroids may participate.

          4. Other significant or uncontrolled medical illness. Patients with a remote history of
             asthma or active mild asthma may participate.

          5. Patients who, in the opinion of the Principal Investigator, have significant medical
             or psychosocial problems that warrant exclusion