Expired Study
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Rochester, Minnesota 55905


Purpose:

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 randomized phase II trial is studying two different types of vaccines to compare how well they work in treating patients with non-metastatic prostate cancer.


Study summary:

OBJECTIVES: Primary - To compare the progression-free survival rate at 1 year in patients with androgen-independent non-metastatic prostate cancer treated with allogeneic prostate cancer cell vaccine (APCC) with vs without autologous myeloid dendritic cells. Secondary - To compare the toxicities of these regimens in these patients. - To compare the overall survival, progression-free survival, time to PSA progression, and duration of PSA-based response in patients treated with these regimens. - To compare the quality of life of patients treated with these regimens. - To evaluate the ability of the novel dendritic cell-APCC vaccination strategies to induce vaccine-specific immune response in these patients. OUTLINE: Patients are stratified according to 2-year survival probability (< 30% vs ≥ 30%). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive allogeneic prostate cancer cell vaccine (APCC) intradermally (ID) on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. - Arm II: Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection periodically for translational studies. Samples are measured for a number of immune parameters by quantifying T-cell and dendritic cell populations by analysis of surface marker molecules by flow cytometry, T-cell proliferation assay, non-specific cytokine release, lysate-specific cytokine release, and cytokine expression measured by cytometric bead array and qPCR. Patients complete quality-of-life questionnaires periodically. After completion of study treatment, patients are followed periodically for up to 3 years.


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/mm³ - Platelet count ≥ 100,000/mm³ - 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


NCT ID:

NCT00814892


Primary Contact:

Study Chair
Manish Kohli, MD
Mayo Clinic


Backup Contact:

N/A


Location Contact:

Rochester, Minnesota 55905
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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