NCT00901342已完成2 期
An Open Label Study of Sipuleucel-T in Men With Metastatic Castrate Resistant Prostate Cancer
Dendreon33 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2009年10月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 33
- 主要终点
- Number of Participants Who Received At Least 1 Infusion of Sipuleucel-T in Men With Metastatic Castrate-resistant Prostate Cancer (CRPC)
研究概览
简要总结
This is a Multicenter, Open Label, Phase 2 Study of Sipuleucel-T in Men with Metastatic Castrate Resistant Prostate Cancer (CRPC).
详细描述
Subjects received sipuleucel-T at 2-week intervals, for a total of 3 infusions. The study evaluated the safety and magnitude of the immune responses to treatment with sipuleucel-T. All subjects were followed for 30 days following the last infusion of sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse event (SAE)s and cerebrovascular event (CVE)s were collected via Long Term Follow-up Telephone Assessment occurring Q6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically documented adenocarcinoma of the prostate
- •Metastatic disease
- •Castrate resistant prostate cancer
- •Castrate level of testosterone (< 50 ng/dL) achieved via medical or surgical castration
- •Life expectancy of ≥ 3 months
- •Men ≥ 18 years of age
- •Adequate hematologic, renal and liver function
排除标准
- •Presence of known lung, liver, or brain metastases
- •Evidence of neuroendocrine or small cell features
- •Eastern Cooperative Oncology Group (ECOG) performance status > 2
- •Prior treatment with 3 infusions of sipuleucel-T (infusions of APC8015F are not exclusionary)
- •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 six months of registration
- •A requirement for systemic immunosuppressive therapy for any reason
- •A history of allergic reactions attributed to compounds of similar chemical or biologic composition to Sipuleucel-T or granulocyte-macrophage colony-stimulating factor
- •Any infection requiring parenteral antibiotic therapy or causing fever (temp > 100.5F or > 38.1C) within 1 week prior to registration
- •Any medical intervention or other condition which, in the opinion of the Principal Investigator or the Dendreon Medical Monitor, could compromise adherence with study requirements or otherwise compromise the study's objectives
- •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 (ie, ≤ 1 day) of corticosteroids to prevent a reaction to the IV contrast used for CT scans
- •Non-steroidal anti-androgens (eg, 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
- •Chemotherapy
- •Treatment with any other investigational product
结局指标
主要结局
Number of Participants Who Received At Least 1 Infusion of Sipuleucel-T in Men With Metastatic Castrate-resistant Prostate Cancer (CRPC)
时间窗: Day 0 (first infusion) and up to 3 infusions at 2-week intervals
次要结局
未报告次要终点
研究者
研究点 (33)
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