Vaccine Therapy in Treating Patients With Non-Metastatic Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: allogeneic tumor cell vaccine; therapeutic autologous dendritic cells
Intervention description: Given intradermally; Given intradermally
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the prostate; recurrent prostate cancer; stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer; stage IV prostate cancer

Summary:

      RATIONALE: Vaccines made from tumor cells or dendritic cells may help the body build an
      effective immune response to kill tumor cells. It is not yet known which vaccine is more
      effective in treating patients with prostate cancer.

      PURPOSE: This phase II trial is studying how well the combination of a proven effective
      allogenic whole prostate carcinoma cell (APCC) vaccine co-administered with ex vivo generated
      dendritic cells (DCs)(DC-APCC) extend the time to prostate cancer progression.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed adenocarcinoma of the prostate

               -  Biochemically progressive disease defined by two serial PSA measurements obtained
                  ≥ 1 week apart during ongoing optimal androgen-deprivation therapy (e.g.,
                  orchiectomy, luteinizing hormone-releasing hormone [LHRH] agonist, or another
                  equivalent hormonal agent)

                    -  Concurrent LHRH agonist or high-dose bicalutamide required (unless patient
                       has undergone prior orchiectomy)

          -  Has undergone prior standard primary therapy for prostate cancer (e.g., radical
             prostatectomy, radiotherapy, or an equivalent initial treatment directed towards
             localized prostate cancer)

          -  PSA 2.0-100.0 ng/mL

          -  Serum testosterone < 50 ng/dL (unless undergoing antiandrogen monotherapy)

          -  No concurrent evidence of radiological or new clinically palpable metastatic cancer

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-1

          -  Life expectancy ≥ 12 weeks

          -  WBC ≥ 3,500/µL

          -  Platelet count ≥ 100,000/µL

          -  Hemoglobin ≥ 10.0 g/dL

          -  Creatinine ≤ 2.0 mg/dL

          -  Alkaline phosphatase ≤ 2.5 times upper limit of normal (ULN)

          -  AST ≤ 2.5 times ULN

          -  Fertile patients must use effective contraception

          -  Willing to provide blood samples for research purposes

          -  Able to complete questionnaire(s) alone or with assistance

          -  Able to undergo leukapheresis

          -  No known immunodeficiency

          -  No other malignancy within the past 5 years except basal cell or squamous cell
             carcinoma of the skin treated with local resection only

          -  No concurrent serious illness

          -  No known history of positive PPD skin test

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  Recovered from prior therapy

          -  More than 1 month since prior and no concurrent corticosteroids or other
             immunosuppressive agents

               -  Inhaled corticosteroids allowed

          -  More than 1 month since prior and no concurrent estrogens and/or ketoconazole

          -  More than 3 months since prior and no other concurrent investigational medicinal
             products

          -  More than 4 weeks since prior and no concurrent secondary hormonal maneuver with or
             without a peripheral antiandrogen (e.g., bicalutamide), PC-SPES, or any other herbal
             medicines used to treat prostate cancer

          -  No prior prostate cancer vaccine

          -  No other therapy for prostate cancer (e.g., chemotherapy, immunotherapy, radiotherapy,
             or new hormonal therapy) during and for 4 months after completion of study therapy

          -  No other concurrent standard therapy that is potentially curative or proven capable of
             extending life expectancy