CTIS2023-503938-52-00招募中1 期
Clinical and translational controlled study of Perampanel treatment around Surgery in patients with progressive glioblastoma (PerSurge) - PerSurge
niversitaetsklinikum Heidelberg AöR0 个研究点目标入组 66 人开始时间: 2023年9月13日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 66
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Histologically confirmed glioblastoma, progressive or recurrent after 1 or 2 lines of prior treatment, involving one radiotherapy and drug treatments according to institutional standards or prior trial participation, >3 months after end of radiotherapy, and therapy for relapse not yet started., Cognitive state to understand rationale, necessity and individual consequences of study therapy and procedures., Female patients with reproductive potentiala must use an approved contraceptive method during and for 4 weeks after the end of trial medication (Pearl Index <1%), Female patients with reproductive potential: a negative serum pregnancy test (beta- HCG) must be obtained prior to treatment start., Indication for surgical resection of progressive or recurrent tumour tissue, with a safe waiting interval of up to 5 weeks., A sufficient amount of resected tumour tissue (minimum 0.5 cm3) is expected to be available for the trial-specific molecular, morphological, functional and perampanel level analysis., Tumour progression according to RANO criteria, Age =18 years, Karnofsky Performance status score (KPS) = 60%, Life expectancy > 3 months, Willing and able to comply with regular neurocognitive and health-related quality of life tests/questionnaires., Written informed consent
排除标准
- •Participation in other ongoing interventional clinical trials., Concomitant intake of enzyme-inducing antiepileptic drugs (EIAEDs: carbamazepine, eslicarbazepine, oxcarbazepine, phenobarbital, phenytoin, primidon, rufinamid), Steroid intake of more than 4 mg dexamethasone (or equivalence dose) in the last week, or expected indication for it in the foreseeable future, History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 2 years unless the patient has been disease-free for 2 years., Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study or the absorption of oral medications or that would, in the opinion of the Principal Investigator, pose an unacceptable risk to the patient in this study., Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; those conditions should be discussed with the patient before trial entry., Pregnancy or breastfeeding, History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product., The presence of any other concomitant severe, progressive, or uncontrolled renal, hepatic, haematological, endocrine, pulmonary, cardiac, or psychiatric disease, or signs or symptoms thereof, that may affect the subject’s participation in the study, according to investigators judgement., Inability to undergo contrast-enhanced MRI., Inability to undergo surgery (e.g. because of need for continuous anticoagulation, known bleeding disorders, thrombocytopenia <50/nl, pre-existing wound healing problems)., Any continued or planned standard or experimental treatment for the tumour other than resection, including antiangiogenic therapy (such as Bevacizumab), and local therapy in addition to the planned resection, including BCNU wafers, loco-regional hyperthermia, tumour bed irradiation, and photodynamic therapy., Tumour carries a known mutation in the IDH1 or IDH2 gene, Severe or significant abnormal (= Grade 3 CTCAE v5.0) laboratory values for haematology (Hb, WBC, neutrophils, or platelets), liver (serum bilirubin, ALT, or AST) or renal function (serum creatinine)., Known active tuberculosis; HIV infection or active Hepatitis B (HBV) or Hepatitis C (HCV infection, or active infections requiring oral or intravenous antibiotics or that can cause a severe disease and pose a severe danger to lab personnel working on patients’ blood or tissue (e.g. rabies)., Any prior treatment with perampanel, Contraindication against treatment with perampanel
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