Pharmacoscopy for Patients With Refractory Primary Brain Tumors
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 9
- 主要终点
- To demonstrate the overall feasibility of pharmacoscopy-guided treatment for patients with refractory primary brain tumors
研究概览
简要总结
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
- •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
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Pharmacoscopy 1.0 (Device)
结局指标
主要结局
To demonstrate the overall feasibility of pharmacoscopy-guided treatment for patients with refractory primary brain tumors
时间窗: 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).
次要结局
- To explore the efficacy of pharmacoscopy-guided treatment - 1(12 months)
- To explore the efficacy of pharmacoscopy guided treatment - 2(12 months)
- To explore the efficacy of pharmascopy guided treatment - 3(12 months)
- To explore the efficacy of pharmascopy guided treatment - 4(24 months)
- To confirm the safety and tolerability of treatment selected based on pharmacoscopy - 1(12 months)
- To confirm the safety and tolerability of treatment selected based on pharmacoscopy -2(12 months)
- To confirm the safety and tolerability of treatment selected based on pharmacoscopy - 3(12 months)
- Quality of life -1(12 months)
- Quality of life - 2(12 months)