HGG-TCP (High Grade Glioma - Tumor Concentrations of Protein Kinase Inhibitors)

• Status: Recruiting
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VU University Medical Center
• Treatments: Erlotinib Hydrochloride; Protein Kinase Inhibitors; Sunitinib

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 - 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

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

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)