AN OPEN-LABEL STUDY OF SIPULEUCEL-T IN EUROPEAN MEN WITH METASTATIC, CASTRATE RESISTANT PROSTATE CANCER

Dendreon Corporation0 个研究点目标入组 45 人开始时间: 2012年9月25日最近更新: 2014年10月27日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Dendreon Corporation
入组人数: 45

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: Male

入选标准

•1 Written informed consent obtained prior to the initiation of study procedures.
•2 Males, age = 18 years at time of registration.
•3 Histologically documented adenocarcinoma of the prostate.
•4 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.
•5 Castrate resistant prostate cancer. Subjects must have current or historical evidence of disease progression concomitant with surgical or medical castration, as demonstrated by PSA progression OR progression of measurable disease OR progression of non-measurable disease.
•6 Serum PSA = 5.0 ng/mL.
•7 Castration levels of testosterone (= 50 ng/dL; = 1.74 nmol/L) achieved via medical or surgical castration.
•8 ECOG performance status = 1 (see Appendix 1).
•9 Adequate hematologic, renal, and liver function.
•10 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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 15
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

排除标准

•1 The presence of known brain metastases. In the case of suspected or questionable findings, the Investigator must address each finding in the subject’s medical record prior to registration.
•2 A requirement for systemic immunosuppressive therapy for any reason.
•3 Treatment with any investigational vaccine within 2 years prior to registration.
•4 Any previous treatment with sipuleucel T.
•5 Any previous treatment with ipilimumab (Yervoy™, MDX-010, or MDX-101) or denosumab (Xgeva™).
•6 Pathologic long-bone fractures, imminent pathologic long-bone fracture (cortical erosion on radiography > 50%), or spinal cord compression.
•7 Subject with known malignancies other than prostate cancer that are likely to require treatment within 6 months of registration.
•8 A history of allergic reactions attributed to compounds of similar chemical or biologic composition to sipuleucel T or GM-CSF.
•9 More than 2 chemotherapy regimens at any time prior to registration.
•10 Treatment with chemotherapy within 90 days of registration.
•11 Received granulocyte colony-stimulating factor (G-CSF) or GM-CSF within 90 days prior to registration.
•12 Treatment with any of the following medications or interventions within 28 days of registration:
•Systemic corticosteroids.
•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.
•13 Any infection requiring parenteral antibiotic therapy or causing fever (temperature > 100.5°F or 38.1°C) within 7 days prior to registration.
•14 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.

研究者

发起方

Dendreon Corporation

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