Pilot study on the determination of tumor concentrations of protein kinase inhibitors in patients with newly diagnosed high-grade glioma - HGG-TCP High Grade Glioma Tumor Concentrations of protein kinase inhibitors

Vrije Universiteit Medisch Centrum0 个研究点目标入组 15 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

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•1. Patients without a history of brain tumor
•2. Initial brain MR-scan suggesting a high grade glioma, according to the interpretation of an expert neuroradiologist
•3. On initial MR-scan a tumor localisation that is deemed resectable without major neurological deficits
•4. Patients must have a Karnofsky Performance Score >= 70%
•5. Patients must have a RTOG Neurologic Function Status of 0-2
•6. Patients need to have adequate hematological, renal and hepatic function as assessed by the following laboratory requirements to be conducted within seven days prior to start study treatment:
•- Hemoglobin > 7.0 mmol/l
•- Absolute neutrophil count (ANC) >1,5 x 10*9/l
•- Platelet count > 100 x 10*9/l
•- ALT and AST< 2.5 x ULN
•- Alkaline phosphatase < 4 x ULN
•- Serum creatinine eGFR > 50 ml/min ;7. Patients are 18 years of older
•8. Male and female patients with reproductive potential must use an approved contraceptive method during and for three months after discontinuation of study treatment
•9. Patients need to give informed consent
•10. Patients should be able to swallow oral medication

•1. Patients receiving prior chemotherapy, radiotherapy or anti-angiogenic therapy
•2. Use of anti-coagulant therapy
•3. Use of CYP3A4 enzyme-inducing drugs, other than dexamethasone (including Carbamazepine, Phenytoine, Phenobarbital)
•4. Initial MR-scan of the brain showing tumor hemorrhage or intracerebral hemorrhage
•5. Patients with progressive neurological symptoms despite dexamethasone
•6. Inability to comply with protocol or study procedures
•7. Pregnancy
•8. Patients with uncontrolled arterial hypertension. Blood pressure must be <=160/95 mmHg at the time of screening on a stable antihypertensive regimen.
•9. Patients with a history of cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
•10. Patients with evidence or history of bleeding diathesis
•11. Patients with a history of venous or arterial thrombo-embolic events or hemorrhagic disease during the past six months
•12. Patients with a history of congestive heart failure (NYHA III, IV)
•13. Patients with a history of peripheral vascular disease (Fontaine stage III and IV)
•14. Patients with stroke or myocardial infarction during the past six months
•15. Patients with a history of a recent peptic ulcer disease (endoscopically-proven gastric ulcer, duodenal ulcer of esophageal ulcer) during the past six months
•16. Patients with uncontrolled infections (> grade 2 NCI-CTC version 4.0)

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