Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
47 participants
INTERVENTIONAL
2012-06-30
2014-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
MALE
No
Sponsors
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Dendreon
INDUSTRY
Responsible Party
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Principal Investigators
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Andrew Stubbs, PhD
Role: STUDY_DIRECTOR
Dendreon
Locations
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Ludwig Boltzmann-Institute for Applied Cancer Research
Vienna, , 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
Countries
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Other Identifiers
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2011-001192-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
P11-1
Identifier Type: -
Identifier Source: org_study_id