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Sipuleucel-T Manufacturing Demonstration Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dendreon
ClinicalTrials.gov Identifier:
NCT01477749
First received: November 19, 2011
Last updated: November 4, 2015
Last verified: November 2015
  Purpose
To demonstrate that sipuleucel-T can be successfully manufactured for subjects with metastatic castrate resistant prostate cancer (mCRPC) at a European manufacturing facility.

Condition Intervention Phase
Cancer of Prostate
Cancer of the Prostate
Neoplasms, Prostate
Neoplasms, Prostatic
Prostate Cancer
Prostate Neoplasms
Prostatic Cancer
Biological: sipuleucel-T
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: An Open-Label Study Study of Sipuleucel-T in European Men With Metastatic, Castrate Resistant Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Dendreon:

Primary Outcome Measures:
  • Cumulative CD54+ Cell Count [ Time Frame: Before and after culture with PAP-GM-CSF, on Day 3 (first infusion) and on approximately Days 17 and 31 (second and third infusion, respectively) ] [ Designated as safety issue: No ]

    Descriptive summarization of the cumulative sum of CD54+ counts across infusions.

    Cumulative CD54 upregulation = CD54 upregulation for infusion 1 + CD54 upregulation for infusion 2 + CD54 upregulation for infusion 3


  • Cumulative CD54 Upregulation [ Time Frame: Before and after culture with PAP-GM-CSF, on Day 3 (first infusion) and on approximately Days 17 and 31 (second and third infusion, respectively) ] [ Designated as safety issue: No ]
    The increase in surface CD54 on APCs, expressed as an upregulation ratio of the average number of molecules on post-culture versus pre-culture cells. Cumulative CD54 upregulation = CD54 upregulation ratio for infusion 1 + CD54 upregulation ratio for infusion 2 + CD54 upregulation ratio for infusion 3.

  • Cumulative Total Nucleated Cell (TNC) Count [ Time Frame: Before and after culture with PAP-GM-CSF, on Day 3 (first infusion) and on approximately Days 17 and 31 (second and third infusion, respectively) ] [ Designated as safety issue: No ]
    Descriptive summarization of the cumulative sum of TNC counts across infusions

  • Product Viability (Percentage) [ Time Frame: Before and after culture with PAP-GM-CSF, on Day 3 (first infusion) and on approximately Days 17 and 31 (second and third infusion, respectively) ] [ Designated as safety issue: No ]
    Product viability was measured as the percentage of live PBMC in final product for infusion 1, 2, and 3 as measured by a trypan blue assay and are reported for each final product for infusion 1, 2, and 3.


Enrollment: 47
Study Start Date: June 2012
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sipuleucel-T
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.
Biological: sipuleucel-T
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.
Other Names:
  • PROVENGE
  • APC8015

Detailed Description:

This was an open-label, uncontrolled, multi-center study. Study participants will underwent screening procedures to ensure that they met the inclusion and exclusion criteria. Subjects underwent a standard 1.5 to 2.0 blood volume leukapheresis, followed approximately 3 days later by an infusion of sipuleucel-T. This process was be repeated at approximately 2-week intervals for a total of 3 infusions.

In Austria, The Netherlands, and France, a study completion visit occurred between 30 and 37 days post-final infusion, or between 30 and 37 days post-final leukapheresis for subjects not receiving at least 1 infusion. In the UK, a follow-up visit occurred 30 days after the subject's final infusion and a study completion visit occurred 6 months after the subject's final infusion.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01477749

Locations
Austria
Ludwig Boltzmann-Institute for Applied Cancer Research
Wien, Austria, A-1100
France
Department of Cancer Medicine and Genitourinary Oncology Group Institut Gustave Roussy (IGR) Département de médicine
Vaillant, Villejuif Cedex, France, 94805
Netherlands
Radboud University Nijmegen; UMC St Radboud Hospital; Faculteit der Medische Wetenschappen, Urologie
Nijmegen, Gelderland, Netherlands, 6525 GA
United Kingdom
Barts Cancer Institute - a Cancer Research UK Centre of Excellence, Queen Mary University of London
London, United Kingdom, EC1M 6BQ
Sponsors and Collaborators
Dendreon
Investigators
Study Director: Andrew Stubbs, PhD Dendreon
  More Information

Responsible Party: Dendreon
ClinicalTrials.gov Identifier: NCT01477749     History of Changes
Other Study ID Numbers: P11-1  2011-001192-39 
Study First Received: November 19, 2011
Results First Received: June 10, 2015
Last Updated: November 4, 2015
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service

Keywords provided by Dendreon:
prostate cancer
prostate
immune therapy
immunotherapy
vaccine
dendritic cells
antigen-presenting cells
antigen presenting cells
cancer vaccine
PSA
prostatic adenocarcinoma

Additional relevant MeSH terms:
Prostatic Neoplasms
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on September 29, 2016