耐火原发性脑肿瘤患者的药物镜检查 (EViDENCE-BT)
Advanced technology of ex vivo drug profiling referred to as pharmacoscopy may allow to identify novel drugs for the treatment of glioblastoma and other refractory brain tumors at an individual patient level. This personalized therapeutic approach was developed and validated in pre-clinical glioma models. With the current research proposal, we seek to establish feasibility for a clinical interventional trial for patients with refractory primary brain tumors that is based on pharmacoscopy-guided selection of treatment.
The study is supported by an unrestricted grant from Anti Cancer Fund.
研究概览
研究类型
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习联系方式
- 姓名：Michael Weller, Prof. Dr. med.
- 电话号码：+41442555500
- 邮箱：EViDENCE-BT@usz.ch
学习地点
-
-
Basel-Landschaft
-
Basel、Basel-Landschaft、瑞士、4021
- 尚未招聘
- University Hospital Basel
-
接触：
- Gregor Hutter, Prof. Dr. med.
- 电话号码：+41612657124
- 邮箱：Gregor.Hutter@usb.ch
-
-
Canton of St. Gallen
-
Sankt Gallen、Canton of St. Gallen、瑞士、9007
- 尚未招聘
- Cantonal Hospital St Gallen
-
接触：
- Marian Neidert, PD Dr. med.
- 电话号码：+41714941199
- 邮箱：marian.neidert@kssg.ch
-
-
Canton of Zurich
-
Zurich、Canton of Zurich、瑞士、8091
- 招聘中
- University Hospital Zurich
-
接触：
- Emilie Le Rhun, PD Dr med
- 电话号码：+41442553899
- 邮箱：EViDENCE-BT@usz.ch
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age 18 years or older on day of signing informed consent, female or male.
- Refractory glioblastoma, isocitrate dehydrogenase (IDH)-mutant astrocytoma or oligodendroglioma, histone-mutant glioma, ependymoma, medulloblastoma, meningioma or other rare primary brain tumor with a histological confirmation according to the WHO classification 2021. Primary tumors can be located at the cerebral or spinal level. Primary brain tumors with metastases outside of the brain may also be considered.
- Karnofsky performance status of 60 or more
- Life expectancy >12 weeks.
- Limited systemic therapeutic options as per treating physician judgement. The number of previous lines of therapies is not limited.
- Surgery clinically indicated. A histological confirmation of the diagnosis of a recurrent brain tumor will be required before any treatment can be initiated.
- Adequate bone marrow, renal and hepatic function
- Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and return for the required assessments.
- Written informed consent for study participation must be signed and dated by the patient and the investigator prior to any study-related intervention.
Exclusion Criteria:
- Inability to undergo brain or spine MRI.
- Concurrent treatment with other systemic tumor-directed pharmacotherapies.
- Intent to be treated with radiotherapy.
- Any investigational antitumor therapy other than those under investigation in this study.
- Judgment by the investigator that the patient should not participate in the study because the patient is unlikely to comply with study procedures, restrictions and requirements.
- Intention to become pregnant during the course of the study or pregnancy. Women of childbearing potential, including women who had their last menstruation in the last 2 years, must have a negative urinary or serum pregnancy test.
- Women who are breast feeding and who do not agree to discontinue nursing prior to the first study treatment and for the period defined in the protocol.
- Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the study.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：All patients will have their tumor analyzed by pharmacoscopy.
Therapeutic decisions will be taken considering the results of the pharmacoscopy analysis, and also standard histopathological and molecular analysis, including next generation sequencing, molecular profiling analysis as available, characteristics of the patient and previous treatments received. |
The intervention is the submission of freshly obtained surgical material to ex vivo drug profiling which we term pharmacoscopy (PCY). The performance study is interventional as the test results shall influence patient management decisions and/or may be used to guide treatment. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
To demonstrate the overall feasibility of pharmacoscopy-guided treatment for patients with refractory primary brain tumors
大体时间：2 months
|
The feasibility is defined as: 80% success rate of generating a pharmacoscopy result within 10 days of surgery (32/40 patients), 50% success rate of placing patients on selected drug based on pharmacoscopy (16/32 patients). |
2 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
To explore the efficacy of pharmacoscopy-guided treatment - 1
大体时间：12 months
|
(1) Response rate |
12 months
|
|
To explore the efficacy of pharmacoscopy guided treatment - 2
大体时间：12 months
|
duration of response |
12 months
|
|
To explore the efficacy of pharmascopy guided treatment - 3
大体时间：12 months
|
progression-free survival |
12 months
|
|
To explore the efficacy of pharmascopy guided treatment - 4
大体时间：24 months
|
overall survival |
24 months
|
|
To confirm the safety and tolerability of treatment selected based on pharmacoscopy - 1
大体时间：12 months
|
Neurological function (NANO scale, Nayak et al. 2017) |
12 months
|
|
To confirm the safety and tolerability of treatment selected based on pharmacoscopy -2
大体时间：12 months
|
Karnofsky performance status (score 0-100) |
12 months
|
|
To confirm the safety and tolerability of treatment selected based on pharmacoscopy - 3
大体时间：12 months
|
Steroid use (dose in mg equivalent dexamethasone) |
12 months
|
|
Quality of life -1
大体时间：12 months
|
EORTC QLQ C30 auto-questionnaire |
12 months
|
|
Quality of life - 2
大体时间：12 months
|
EORTC BN20 autoquestionnaire |
12 months
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Translational research
大体时间：12 months
|
prospective assessement of the value of liquid biopsy in parallel of imaging assessment |
12 months
|
合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- EViDENCE-BT
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.