Status:
UNKNOWN
HGG-TCP (High Grade Glioma - Tumor Concentrations of Protein Kinase Inhibitors)
Lead Sponsor:
Amsterdam UMC, location VUmc
Conditions:
Cancer
High-grade Glioma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine intratumoral concentration of kinase inhibitors upon 2 weeks of treatment in tumor tissue (in the brain) of patients with high-grade gliomas (HGG).
Detailed Description
In clinical trials for HGG, multiple agents targeting various oncogenic signaling pathways that play an important role in the biology of HGG have been studied, but unfortunately only a small number of...
Eligibility Criteria
Inclusion
- Patients without a history of brain tumor
- Initial brain MR-scan suggesting a high grade glioma, according to the interpretation of an expert neuroradiologist
- On initial MR-scan a tumor localisation that is deemed resectable without major neurological deficits
- Patients must have a Karnofsky Performance Score ≥ 70%
- Patients must have a RTOG Neurologic Function Status of 0-2
- 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
- Patients are 18 years of older
- Male and female patients with reproductive potential must use an approved contraceptive method during and for three months after discontinuation of study treatment
- Patients need to give informed consent
- Patients should be able to swallow oral medication
Exclusion
- Patients receiving prior chemotherapy, radiotherapy or anti-angiogenic therapy
- Use of anti-coagulant therapy
- Use of CYP3A4 enzyme-inducing drugs, other than dexamethasone (including Carbamazepine, Phenytoine, Phenobarbital)
- Initial MR-scan of the brain showing tumor hemorrhage or intracerebral hemorrhage
- Patients with progressive neurological symptoms despite dexamethasone
- Inability to comply with protocol or study procedures
- Pregnancy
- Patients with uncontrolled arterial hypertension. Blood pressure must be ≤160/95 mmHg at the time of screening on a stable antihypertensive regimen.
- Patients with a history of cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
- Patients with evidence or history of bleeding diathesis
- Patients with a history of venous or arterial thrombo-embolic events or hemorrhagic disease during the past six months
- Patients with a history of congestive heart failure (NYHA III, IV)
- Patients with a history of peripheral vascular disease (Fontaine stage III and IV)
- Patients with stroke or myocardial infarction during the past six months
- Patients with a history of a recent peptic ulcer disease (endoscopically-proven gastric ulcer, duodenal ulcer of esophageal ulcer) during the past six months
- Patients with uncontrolled infections (\> grade 2 NCI-CTC version 4.0)
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2021
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT02239952
Start Date
November 1 2014
End Date
November 1 2021
Last Update
October 8 2020
Active Locations (1)
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1
VU University Medical Center
Amsterdam, North Holland, Netherlands, 1081 HV