Sipuleucel-T Manufacturing Demonstration Study
Condition: Cancer of Prostate; Cancer of the Prostate; Neoplasms, Prostate; Neoplasms, Prostatic; Prostate Cancer; Prostate Neoplasms; Prostatic Cancer
MeSH terms: Prostatic Neoplasms; Neoplasms
Intervention: sipuleucel-T
Intervention description: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
Phase: Phase 2
Study type: Interventional
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: prostate cancer; prostate; immune therapy; immunotherapy; vaccine; dendritic cells; antigen-presenting cells; antigen presenting cells; cancer vaccine; PSA; prostatic adenocarcinoma

Summary:

      To demonstrate that sipuleucel-T can be successfully manufactured for subjects with
      metastatic castrate resistant prostate cancer (mCRPC) at a European manufacturing facility.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically documented adenocarcinoma of the prostate

          -  Metastatic disease as evidenced by soft tissue and/or bony metastases on bone scan
             and/or computed tomography (CT) scan of the abdomen and pelvis at any time prior to
             registration

          -  Castrate resistant prostate cancer

          -  Serum PSA ≤ 5.0 ng/mL

          -  Castration levels of testosterone (≤ 50 ng/dL; ≤ 1.74 nmol/L) achieved via medical or
             surgical castration. Surgical castration must have occurred at least 3 months prior to
             registration.

          -  ECOG performance status ≤ 1

          -  Adequate hematologic, renal, and liver function

          -  Negative serology tests indicating no active infection with human immunodeficiency
             virus types 1 and 2 (HIV-1/2), human T cell lymphotropic virus types 1 and 2
             (HTLV-I/II), and Hepatitis B and C viruses.

        Exclusion Criteria:

          -  The presence of known brain metastases

          -  A requirement for systemic immunosuppressive therapy for any reason

          -  Treatment with any investigational vaccine within 2 years prior to registration

          -  Any previous treatment with sipuleucel-T

          -  Any previous treatment with ipilimumab (Yervoy[TM], MDX-010, or MDX-101) or denosumab
             (Xgeva[TM])

          -  Pathologic long-bone fractures, imminent pathologic long-bone fracture (cortical
             erosion on radiography > 50%), or spinal cord compression

          -  Known malignancies other than prostate cancer that are likely to require treatment
             within 6 months of registration

          -  A history of allergic reactions attributed to compounds of similar chemical or
             biologic composition to sipuleucel-T or GM-CSF

          -  More than 2 chemotherapy regimens at any time prior to registration

          -  Treatment with any chemotherapy within 90 days of registration

          -  Received granulocyte colony-stimulating factor (G-CSF) or GM-CSF within 90 days prior
             to registration

          -  Treatment with any of the following medications or interventions within 28 days of
             registration:

          -  Systemic corticosteroids. Use of inhaled, intranasal, intra-articular, and topical
             steroids is acceptable, as is a short course (i.e., ≤ 1 day) of corticosteroids to
             prevent a reaction to the IV contrast used for CT scans.

          -  Non-steroidal anti-androgens (e.g., bicalutamide, flutamide, or nilutamide)

          -  External beam radiation therapy or major surgery requiring general anesthetic

          -  Any other systemic therapy for prostate cancer including secondary hormonal therapies,
             such as megestrol acetate (Megace®), diethylstilbestrol (DES), and ketoconazole.
             Medical castration therapy is not exclusionary.

          -  Immunosuppressive therapy

          -  Treatment with any other investigational product

          -  Any infection requiring parenteral antibiotic therapy or causing fever (temperature >
             100.5°F or 38.1°C) within 7 days prior to registration.

          -  Any medical intervention or other condition which, in the opinion of the Investigator
             or the Dendreon Medical Monitor, could compromise adherence with study requirements or
             otherwise compromise the study's objectives.