Personalized Targeted Glioblastoma Therapies by ex Vivo Drug Screening: Advanced Brain Tumor TheRApy Clinical Trial (ATTRACT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Overall survival time
研究概览
简要总结
Patient derived cell line (PDC) -based drug screening will be applied to formulate a personalized treatment approach.
详细描述
Patient derived cell line (PDC) -based drug screening will be applied to formulate a personalized treatment approach. Patients will be randomized between the investigational group receiving in addition to standard histology analysis also the PDC-based drug screening and the standard group receiving only standard histology analysis. Outcome results will be compared in a randomized, interventional clinical performance study. The PDC-based drug screening will be performed only in accordance with the approved Performance Study Plan on subjects who have signed an informed consent form.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75
- •ECOG performance status 0-2
- •Newly diagnosed glioblastoma, IDH wildtype - according to the 2021 WHO classification of Tumors of the Central Nervous System
- •MGMT promotor unmethylated per local investigator
- •Tissue available for drug screening (successful PDC establishment from surgical material)
- •Scheduled for concomitant radio-chemotherapy with temozolomide
- •Written informed consent
排除标准
- •Current participation in another therapeutic clinical trial
- •Patients with a concurrent malignancy or malignancy within five years prior of study enrolment except for carcinoma in situ of the cervix, non-melanoma skin carcinoma or stage I uterine cancer within the last 3 years
- •Pregnant or lactating women
- •Current known infection with hepatitis B virus (HBV), or hepatitis C virus (HCV). Patients with past HBV infection or resolved HBV infection (defined as having a negative hepatitis B surface antibody [HBsAg] test and a positive anti-hepatitis B core antibody [HBcAb] test, accompanied by a negative HBV DNA test) are eligible. Patients positive for anti-HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.
- •Known human immunodeficiency virus (HIV) infection that is not well controlled. All of the following criteria are required to define an HIV infection that is well controlled: undetectable viral RNA, CD4+ count ≥350 cells/mm3 , no history of AIDS-defining opportunistic infection within the past 12 months, and stable for at least 4 weeks on the same anti-HIV medications (meaning there are no expected further changes in that time to the number or type of antiretroviral drugs in the regimen). If an HIV infection meets the above criteria, monitoring of viral RNA load and CD4+ count is recommended.
- •Any of the following co-morbidities:
- •Pre-existing severe peripheral neuropathy (> CTCAE grade 2)
- •Hepatic impairment (Bilirubin Level >1.5x-3x ULN)
- •Kidney dysfunction (CrCl < 59 mL/min)
- •Cardiac dysfunction with left ventricular ejection fraction <60 %
- •Any grade of interstitial lung disease
- •Ongoing or previous history of rhabdomyolysis
- •Acute pancreatitis
- •QTcF ≥480 msec
- •Diabetes mellitus with fasting glucose > 250mg/dl or 13.9 mmol/L
- •Participants who are unable or unwilling to comply with the requirements of the protocol as assessed by the investigator.
研究组 & 干预措施
PDC-based drug screening
120 patients will be included in the intervention group and will receive PDC-based drug screening. The molecular tumor board will formulate a personalized treatment recommendation by incorporating the individual characteristics of the patients including age, co-morbidities, co-medication, and performance status in addition to the results of the PDC-based drug screening.
干预措施: CBMed Drug Screening Plattform (Diagnostic Test)
Standard group
120 patients will be included in the standard group and will not receive PDC-based drug screening. In line, no personalized treatment approach will be formulated by the molecular tumor board and patients will all receive the recommendation for standard treatment including temozolomide maintenance therapy for 6 cycles.
结局指标
主要结局
Overall survival time
时间窗: From date of randomization until date of death from any cause or last follow up whichever came first, assessed up to 144 months
Change in overall survival in patients receiving extensive diagnostic work up including the standard histology analysis and PDC- based drug screening in addition (interventional arm) compared to patients receiving only standard histology diagnostic work up (standard arm)
次要结局
- Feasibility of PDC-based drug screening(From date of randomization until date of communication of the tumor board outcome, asses up to 144 months)
- Comparison of Quality of life measurements(From date of randomization until date of death from any cause or last follow up whichever came first, assessed up to 144 months)
- Comparison of neurocognitive function scale(From date of randomization until date of death from any cause or last follow up whichever came first, assessed up to 144 months)
研究者
Anna Berghoff
Assoc.-Prof. PD DDr.
Medical University of Vienna