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Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00814892 |
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.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: allogeneic tumor cell vaccine Drug: therapeutic autologous dendritic cells |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label |
Official Title: | A Randomized Phase II Clinical Trial to Determine the Safety, Tolerability and Efficacy of an Allogeneic Whole Cell Vaccine Administered With or Without Autologous Myeloid Dendritic Cells to Patients With Non-Metastatic Androgen Independent Prostate Carcinoma |
Estimated Enrollment: | 60 |
Study Start Date: | January 2009 |
Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Experimental
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.
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Drug: allogeneic tumor cell vaccine
Given intradermally
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Arm II: Experimental
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.
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Drug: allogeneic tumor cell vaccine
Given intradermally
Drug: therapeutic autologous dendritic cells
Given intradermally
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OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are stratified according to 2-year survival probability (< 30% vs ≥ 30%). Patients are randomized to 1 of 2 treatment arms.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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)
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
More than 1 month since prior and no concurrent corticosteroids or other immunosuppressive agents
Responsible Party: | Mayo Clinic Cancer Center ( Clinical Trials Office ) |
Study ID Numbers: | CDR0000630404, MAYO-MC0554, MAYO-06-004659 |
Study First Received: | December 24, 2008 |
Last Updated: | December 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00814892 |
Health Authority: | Unspecified |
adenocarcinoma of the prostate recurrent prostate cancer stage I prostate cancer |
stage II prostate cancer stage III prostate cancer stage IV prostate cancer |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male |
Adenocarcinoma Prostatic Neoplasms Recurrence Carcinoma |
Neoplasms Neoplasms by Site |