A Study of Intratumorally-Administered Topotecan Using Convection-Enhanced Delivery (CED) in Patients With Suspected Recurrent/Progressive World Health Organization (WHO) Grade III or IV (High Grade) Glioma Undergoing Stereotactic Biopsy
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Distribution of topotecan in tumor tissue
研究概览
简要总结
The purpose of this study is to determine if treatment with Topotecan by an alternative method, delivering topotecan directly into brain tumors, is safe and well tolerated.
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
- •Histologically confirmed diagnosis of supratentorial WHO Grade III or IV Glioma (High Grade Glioma) that has undergone surgical biopsy or resection followed by adjuvant chemoradiotherapy, that has evidence of recurrence or progression based on imaging studies and a stereotactic biopsy is indicated for confirmation of recurrence/progression.
- •18 years of age or older
- •Karnofsky Performance Status 70-100;
- •MRI demonstration of a stereotactically accessible enhancing or predominantly non- enhancing mass that does not require resection to relieve clinically significant mass effect;
- •Participant understands the procedures and agrees to comply with the study requirements by providing written informed consent
- •Adequate organ function as indicated in protocol
排除标准
- •Participant is mentally or legally incapacitated at the time of the study;
- •Known HIV(+) or has been diagnosed with AIDS
- •Participation in another investigational drug study in the prior 4 weeks
- •Positive pregnancy test in a female
- •Patient, in the opinion of the investigator, is likely to be poorly compliant.
- •Diffuse subependymal or Cerebral Spinal Fluid (CSF) disease
- •Tumors involving the cerebellum
- •Tumor enhancement involving both hemispheres
- •Active infection requiring treatment
- •Unexplained febrile illness
- •Radiation or chemotherapy within 4 weeks of enrollment
- •Systemic diseases associated with unacceptable anesthesia or operative risk
- •Inability to undergo magnetic resonance imaging (MRI)
研究组 & 干预措施
Cleveland Multiport Catheter (CMC) + Topotecan
For predominantly enhanced tumors with volume of 8 cc or less, only 1 Cleveland Multiport Catheter (CMC) will be placed and convection-enhanced delivery (CED) will be performed over a 4-hour period within an MRI scanner, with the goal of complete tumor coverage (as evidenced by tracer distribution on MRI). The initial rate will be 1.20 ml/hour (5.0 microliters/minute/microcatheter) and infusion will be monitored by intermittent MRI imaging. The rate may be adjusted upwards during the infusion, in the event of incomplete tumor coverage, or downwards, if new mass effect is apparent. Following completion of the 4-hour infusion, the CMC will be removed. The initial rate for each subsequent patient may be adjusted upwards in increments of up to 5 microliters/minute/microcatheter based upon the tumor coverage and safety characteristics of the previously treated patients.
干预措施: Topotecan (Drug)
结局指标
主要结局
Distribution of topotecan in tumor tissue
时间窗: Treatment day 1
The spatial distribution of intratumorally-administered topotecan will be determined using a gadolinium-based contrast agent, volumetric magnetic resonance imaging, and three-dimensional image reconstruction.
次要结局
- Extent of topotecan backflow(Treatment day 1)
- Number of Adverse Events (AEs) experienced by participants(Up to 48 weeks)