Long-Term TARP Vaccination Using a Multi-Epitope TARP Peptide Autologous Dendritic Cell Vaccination in Previously Vaccinated Men on NCI 09-C-0139
Condition: Prostatic Neoplasms; Neoplasms of Prostate; Prostate Cancer; Cancer Of Prostate; Stage D0 Prostate Cancer
MeSH terms: Prostatic Neoplasms; Neoplasms
Intervention: Multi-epitope (ME) T-cell Receptor Alternate Reading Frame Protein (TARP) vaccine
Intervention description: dose of 20 x 10^6 viable cells multiepitope TARP dendritic cell vaccine given intradermally at weeks 3, 6, 9, 12, 15 and 24.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multi-epitope; Tarp Peptide; Dendritic Cell Vaccine; D0 Prostate Cancer

Summary:

      Background:

      - Few studies or literature are available about the long-term safety of repeated peptide
      vaccinations in people over a period of time. Long-term vaccination may be needed to control
      tumors. Researchers gave a group of men a series of vaccine injections over 2 years. Now they
      want to give those same men the new version of the vaccine. They want to see if it produces
      different types of immune responses and also ensure that repeated vaccinations are safe.

      Objectives:

      - To find out the long-term safety of repeated T-cell receptor alternate reading frame
      protein (TARP) peptide vaccinations.

      Eligibility:

      - Men who took part in National Cancer Institute (NCI) protocol 09-C-0139.

      Design:

        -  Participants will be screened with blood tests, scans, physical exam, medical history,
           and an evaluation of how well they perform everyday activities.

        -  Participants will have 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 vaccine injections at weeks 3, 6, 9, 12, 15, and 24. The vaccine
           will be made from the participants own cells.

        -  Participants will get a Vaccine Report Card to complete after receiving vaccine.

        -  The study lasts 96 weeks.
    

Eligibility criteria:

        -  INCLUSION CRITERIA:

          -  Males greater than or equal to 18 years of age with histologically confirmed
             adenocarcinoma of the prostate.

          -  Prior enrollment in National Cancer Institute (NCI) protocol 09-C-0139 with receipt of
             at least 5 doses of T cell receptor gamma alternate reading frame protein (TARP)
             peptide vaccine (i.e. completion of primary vaccination series).

          -  Performance Status: Eastern Cooperative Oncology Group (ECOG) 0-1, life expectancy of
             greater than or equal to 1 year.

          -  Hemoglobin greater than or equal to 10.0 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 100,000/mm^3.

          -  Prothrombin time (PT)/partial thromboplastin time (PTT) less than or equal to 1.5X
             upper limit of normal (ULN) unless receiving clinically indicated anticoagulant
             therapy.

          -  Serum glutamic-oxaloacetic transaminase (SGOT)/serum glutamic-pyruvic transaminase
             (SGPT) less than or equal to 2.5X ULN, total bilirubin less than or equal to 1.5X ULN,
             creatinine (Cr) less than or equal to 1.5X ULN, estimated glomerular filtration rate
             (eGFR) greater than or equal to 60 ml/min.

          -  Hepatitis B and C negative, unless the result is consistent with prior vaccination or
             prior infection with full recovery.

          -  Human immunodeficiency virus (HIV) negative

          -  No use of investigational agents within 4 weeks of study enrollment or use of
             immunosuppressive or immunomodulating agents (including Intravenous immune globulin
             (IVIG) within 8 weeks of study entry. Note: Use of topical, inhaled and intranasal
             steroid therapy is permitted.

          -  Greater than or equal to 6 weeks since the receipt of chemotherapy or radiation
             therapy.

          -  Standard of care medical management of current prostate cancer disease status by the
             patients local oncologist, e.g., androgen deprivation therapy is allowed.

          -  Able to understand and provide Informed Consent.

          -  Must be able and willing to adhere to protocol requirements, visits and vaccination
             timeline.

        EXCLUSION CRITERIA:

          -  Patients with a second malignancy requiring active treatment.

          -  Patients with an active infection.

          -  Patients on immunosuppressive therapy including:

             --Systemic corticosteroid therapy for any reason. Patients receiving inhaled,
             intranasal or topical corticosteroids may participate.

          -  Other significant or uncontrolled medical illness. Patients with a remote history of
             or active mild asthma may participate.

          -  Patients who, in the opinion of the Principal Investigator, have significant medical
             or psychosocial problems that warrant exclusion including:

               -  Other serious non-malignancy-associated medical conditions that may be expected
                  to limit life expectancy to less than 2 years.

               -  Any condition- medical, psychiatric or otherwise, that would preclude informed
                  consent, consistent follow-up or compliance with any aspect of the study.