Sipuleucel-T Manufacturing Demonstration Study

This study is currently recruiting participants.
Verified March 2013 by Dendreon
Sponsor:
Information provided by (Responsible Party):
Dendreon
ClinicalTrials.gov Identifier:
NCT01477749
First received: November 19, 2011
Last updated: February 12, 2014
Last verified: March 2013
  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:
  • A descriptive summarization of key product parameters for sipuleucel-T produced at a European manufacturing facility. [ Time Frame: Approximately 1 month from first product manufactured ] [ Designated as safety issue: No ]

    Key product parameters are measured with each product manufactured and will be summarized:

    • CD54+ cell count
    • cumulative CD54 upregulation
    • cumulative total nucleated cell (TNC) count
    • product viability (percentage)


Secondary Outcome Measures:
  • Evaluation of the safety of sipuleucel-T manufactured at a European manufacturing facility. [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    Safety will be assessed by collecting adverse events, laboratory samples, vital signs, ECOG performance status, and physical examinations.


Estimated Enrollment: 45
Study Start Date: June 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (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

  Eligibility

Ages Eligible for Study:   18 Years and older
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01477749

Locations
Austria
Ludwig Boltzmann-Institute for Applied Cancer Research Recruiting
Wien, Austria, A-1100
Contact: Mark Bachner    43 1 60191 2308    mark.bachner@wienkav.at   
Principal Investigator: Maria De Santis         
France
Department of Cancer Medicine and Genitourinary Oncology Group Institut Gustave Roussy (IGR) Département de médicine Recruiting
Vaillant, Villejuif Cedex, France, 94805
Contact: Galina Jépiral    +33 1 42 11 64 41    galina.jepiral@gustaveroussy.fr   
Contact: Mina Khelifa    +33 1 42 11 61 71    mina.khelifa@gustaveroussy.fr   
Principal Investigator: Karim Fizazi, MD, PhD         
Netherlands
Radboud University Nijmegen; UMC St Radboud Hospital; Faculteit der Medische Wetenschappen, Urologie Recruiting
Nijmegen, Gelderland, Netherlands, 6525 GA
Contact: Petra Frenken    0031- (0)24 36 13628 ext 1745    p.frenken@uro.umcn.nl   
Principal Investigator: Peter Mulders, MD         
United Kingdom
Barts Cancer Institute - a Cancer Research UK Centre of Excellence, Queen Mary University of London Recruiting
London, United Kingdom, EC1M 6BQ
Contact: Emma Lawton    02078828507    Emma.lawton@bartshealth.nhs.uk   
Principal Investigator: Thomas Powles, MD         
Sponsors and Collaborators
Dendreon
Investigators
Study Director: Andrew Stubbs, PhD Dendreon
  More Information

No publications provided

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
Last Updated: February 12, 2014
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:
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 21, 2014