EUCTR2008-001144-39-DK进行中（未招募）1 期
A randomized phase II trial with bevacizumab, irinotecan and cerebral radiotherapy versus bevacizumab, temozolomide and cerebral radiotherapy as first line treatment for patients with glioblastoma multiforme
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •·Signed informed consent
- •·Histological verified primary glioblastoma multiforme
- •·No prior therapy for GBM, except for primary surgical resection or biopsy
- •·Expected survival > 3 months
- •·Adequate liver, renal and bone-marrow function, determined as:
- •oThrombocytes > 100 x 109/liter
- •oHemoglobin >6.2 mmol/liter
- •oLeukocytes > 3 x 109/liter
- •oNeutrophil granulocytes > 1.5 x 109/liter
- •oASAT and/or ALAT < 3 x upper normal limit
- •oBilirubin < 1.5 x upper normal limit
- •oSerum-creatinin < upper normal limit or glomerular filtration rate >60 ml/min (corrected for age) determined by measurement of clearance of Cr-EDTA
- •oAPTT < upper normal limit
- •oINR < upper normal limit
- •·Fertile women of childbearing age must use proper anti-conception (oral contraceptives, IUD and/or condom). Fertile men must use condom
- •·No sign of cerebral bleeding on cerebral MR-scanning at baseline
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •·Previous therapy of GBM, including radiotherapy and the use of biological targeted” drug, e.g. drugs targeted against the VEGF- or EGFR pathway
- •·Concurrent use of medication that can affect the interpretation of the results from the study, e.g. use of immunosuppressive drugs, except corticosteroids
- •·Conditions (medical, social or physical) that may compromise proper information and/or follow-up
- •·Other concurrent or previous cancer within 5 years, except adequately treated basal or planocellular skin cancer, or cervical carcinoma in situ
- •·Significant heart disease (according to the New York Heart Association class II or more severe), clinically significant arrhythmia or unstable angina pectoris/acute myocardial infarction within last 6 months
- •·Clinical significant peripheral arterial disease
- •·Known or suspected disorders of coagulation or concurrent therapy with ASA, NSAID or clopidogrel
- •·Major surgery, open biopsy or greater trauma, or expectations thereof, within 28 days prior to start of therapy
- •·Minor surgery or needle biopsy, or expectations thereof, within 7 days prior to start of therapy
- •·Known or suspected abdominal fistulas, gastrointestinal perforations or intra-abdominal abscesses within 6 months prior to start of therapy
- •·Known or active HIV or Hepatitis B/C infection
- •·Concurrent ongoing significant infection or diabetes mellitus not adequately controlled medically
- •·Clinically significant non-healing ulcers
- •·Active ventricular or duodenal ulcers within 6 months prior to start of therapy
- •·Recent bone-fracture (<3 months)
- •·Pregnancy or lactation
- •·Need for systemic anticoagulant therapy at time of start of therapy
- •·Blood pressure > 150/100 mmHg (patients are allowed to receive proper antihypertensive medication)
- •·Proteinuria = 1 gram/day
- •·Known allergy towards irinotecan (or related substance) or vehicle
- •·Known allergy towards temozolomide (or related substance) or vehicle
- •·Known allergy towards bevacizumab (or related substance) or vehicle
研究者
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