Individualized Systems Medicine Strategy for Targeting Cancer Stem Cells in Patients With Recurrent Glioblastoma (ISM-GBM)
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Drug screen completion and treatment initiation
研究概览
简要总结
A study to determine the feasibility and safety of individualized cancer stem cell targeted therapy based on high-throughput functional profiling of FDA/EMA-approved drugs in patients with GBM that has recurred or progressed following standards-of-care (RT, TMZ).
详细描述
This protocol describes a prospective single-center phase 1 study to evaluate the feasibility and safety of a high-throughput drug sensitivity and resistance testing (HTS) platform of individualized cancer stem cells (CSC) to predict targeted therapies in patients with recurrence of GBM after standards-of-care. Secondary outcome include efficacy of drug treatment. The underlying hypotheses is that treatment of patients based on functional profiling og autologous CSCs using HTS a) is feasible within an acceptable time window for clinical translation, b) safely delay disease progression and c) increase survival. There are increasingly published literature that strongly support the importance of a targeting CSC to improve therapy and prevent tumor recurrence in GBM, as an additional strategy to improve the overall prognosis of patients.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recurrence of histologically verified glioblastoma
- •Adequate biopsy to generate enough live cells to allow functional screening
- •Must be ambulatory with an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Must be 18 to 70 years of age
- •Adequate bone marrow, liver and heart function
- •Must be competent to give consent
- •Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to International Conference on Harmonization Good Clinical Practice guidelines (ICH GCP), and national/local regulations.
排除标准
- •Patients taking part in other clinical trials which could make inclusion or follow-up difficult
- •Any reason why, in the opinion of the investigator, the patient should not participate
研究组 & 干预措施
Treatment
Patients will be treated with drugs based on functional profiling of autologous tumor cells in vitro
干预措施: Personalized drug combination (Drug)
结局指标
主要结局
Drug screen completion and treatment initiation
时间窗: 8 weeks after surgery
The fraction of patient that can receive an individualized treatment based on drug screening. These drugs must be available for treatment and with a combined acceptable toxicity.
次要结局
- Overall survival(15 months from inclusion)
- Patient reported quality of life, overall (QLQ-C30)(15 months from inclusion)
- Number of grade 3-5 adverse events(15 months from inclusion)
- Tumor response(15 months from inclusion)
- Patient reported quality of life, brain specific(QLQ-BN20)(15 months from inclusion)
研究者
Einar Vik-Mo
Head of Surgical Neuro-Oncology
Oslo University Hospital