Spots Global Cancer Trial Database for Sipuleucel-T Manufacturing Demonstration Study
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Trial Identification
Brief Title: Sipuleucel-T Manufacturing Demonstration Study
Official Title: An Open-Label Study Study of Sipuleucel-T in European Men With Metastatic, Castrate Resistant Prostate Cancer
Study ID: NCT01477749
Interventions
Study Description
Brief Summary: To demonstrate that sipuleucel-T can be successfully manufactured for subjects with metastatic castrate resistant prostate cancer (mCRPC) at a European manufacturing facility.
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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Ludwig Boltzmann-Institute for Applied Cancer Research, Wien, , Austria
Department of Cancer Medicine and Genitourinary Oncology Group Institut Gustave Roussy (IGR) Département de médicine, Vaillant, Villejuif Cedex, France
Radboud University Nijmegen; UMC St Radboud Hospital; Faculteit der Medische Wetenschappen, Urologie, Nijmegen, Gelderland, Netherlands
Barts Cancer Institute - a Cancer Research UK Centre of Excellence, Queen Mary University of London, London, , United Kingdom
Contact Details
Name: Andrew Stubbs, PhD
Affiliation: Dendreon
Role: STUDY_DIRECTOR
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