NCT02296580已完成不适用
A Feasibility Study of the Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 25
- 主要终点
- Number of any adverse events associated with the investigational therapy.
研究概览
简要总结
This feasibility study will assess the effects of the Nativis Voyager therapy in patients with first or second recurrence of GBM who have either failed standard of care or are intolerant to therapy. The study will enroll and treat up to 32 subjects with Voyager plus lomustine with or without bevacizumab. Safety and clinical utility will be evaluated.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has histologically confirmed diagnosis of GBM.
- •Subject has failed or intolerant to radiotherapy.
- •Subjects has failed or intolerant to temozolomide therapy.
- •Subject has progressive disease with at least one measureable lesion on MRI.
- •Subject is at least 18 years of age.
- •Subject has a KPS ≥
- •Subject has adequate organ and marrow function.
排除标准
- •Subject has received bevacizumab (Avastin).
- •Subjecting has any condition, including compromised pulmonary function, that would preclude the use of lomustine.
- •Subject is currently being treated with other investigational agents.
- •Subject has received other investigational therapy within the last 28 days.
- •Subject has received surgery within the last four weeks.
- •Subject is within 12 weeks of completion of radiation.
- •Subject has an active implantable or other electromagnetic device.
- •Subject has a metal implant, including a programmable shunt, in the head or neck that is incompatible with MRI.
- •Subject is known to be HIV positive.
- •Subject is pregnant, nursing or intends to become pregnant during the course of the study.
结局指标
主要结局
Number of any adverse events associated with the investigational therapy.
时间窗: Through one month following investigational treatment
Safety Assessment as assessed by adverse events
次要结局
- Clinical Utility: OS(18 months)
- Clinical Utility: PFS(Six months)
研究者
研究点 (25)
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