Sipuleucel-T Manufacturing Demonstration Study
This trial is active, not recruiting.
|Conditions||cancer of prostate, cancer of the prostate, neoplasms, prostate, neoplasms, prostatic, prostate cancer, prostate neoplasms, prostatic cancer|
|Start date||June 2012|
|End date||January 2015|
|Trial size||45 participants|
|Trial identifier||NCT01477749, 2011-001192-39, P11-1|
To demonstrate that sipuleucel-T can be successfully manufactured for subjects with metastatic castrate resistant prostate cancer (mCRPC) at a European manufacturing facility.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Wien, Austria||Ludwig Boltzmann-Institute for Applied Cancer Research||no longer recruiting|
|Vaillant, France||Department of Cancer Medicine and Genitourinary Oncology Group Institut Gustave Roussy (IGR) Département de médicine||no longer recruiting|
|Nijmegen, Netherlands||Radboud University Nijmegen; UMC St Radboud Hospital; Faculteit der Medische Wetenschappen, Urologie||no longer recruiting|
|London, United Kingdom||Barts Cancer Institute - a Cancer Research UK Centre of Excellence, Queen Mary University of London||no longer recruiting|
|Intervention model||single group assignment|
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
Evaluation of the safety of sipuleucel-T manufactured at a European manufacturing facility.
time frame: 9 months
Male participants at least 18 years old.
- 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.
- 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.
|Official title||An Open-Label Study Study of Sipuleucel-T in European Men With Metastatic, Castrate Resistant Prostate Cancer|
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