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Clinical Trials/NL-OMON47042
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

Vrije Universiteit Medisch Centrum0 sites15 target enrollmentTBD

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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

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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