Status:
COMPLETED
Sipuleucel-T Manufacturing Demonstration Study
Lead Sponsor:
Dendreon
Conditions:
Cancer of Prostate
Cancer of the Prostate
Eligibility:
MALE
18+ years
Phase:
PHASE2
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 stan...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT01477749
Start Date
June 1 2012
End Date
June 1 2014
Last Update
December 9 2015
Active Locations (4)
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1
Ludwig Boltzmann-Institute for Applied Cancer Research
Vienna, Austria, A-1100
2
Department of Cancer Medicine and Genitourinary Oncology Group Institut Gustave Roussy (IGR) Département de médicine
Vaillant, Villejuif Cedex, France, 94805
3
Radboud University Nijmegen; UMC St Radboud Hospital; Faculteit der Medische Wetenschappen, Urologie
Nijmegen, Gelderland, Netherlands, 6525 GA
4
Barts Cancer Institute - a Cancer Research UK Centre of Excellence, Queen Mary University of London
London, United Kingdom, EC1M 6BQ