NL-OMON47042
Recruiting
Not Applicable
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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Vrije Universiteit Medisch Centrum
- Enrollment
- 15
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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