Clinical trial · Interventional
HGG-TCP (High Grade Glioma - Tumor Concentrations of Protein Kinase Inhibitors)
Pilot Study on the Determination of Tumor Concentrations of Protein Kinase Inhibitors in Patients With Newly Diagnosed High-grade Glioma
NCT02239952CI-TRIAL-00047564unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| High-grade Glioma | High-Grade Glioma, NOS | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Erlotinib | Drug | Erlotinib | ALIAS |
| Sunitinib | Drug | Sunitinib | ALIAS |
| vandetanib | Drug | Vandetanib | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- sunitinib
- interventionNames
- Drug: Sunitinib
- type
- EXPERIMENTAL
- label
- vandetanib
- interventionNames
- Drug: vandetanib
- type
- EXPERIMENTAL
- label
- Erlotinib
- interventionNames
- Drug: Erlotinib
Primary outcomes (1)
- measure
- PKI and active metabolites concentrations in tumor tissue
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDvan Linde ME, Labots M, Brahm CG, Hovinga KE, De Witt Hamer PC, Honeywell RJ, de Goeij-de Haas R, Henneman AA, Knol JC, Peters GJ, Dekker H, Piersma SR, Pham TV, Vandertop WP, Jimenez CR, Verheul HMW. Tumor Drug Concentration and Phosphoproteomic Profiles After Two Weeks of Treatment With Sunitinib in Patients with Newly Diagnosed Glioblastoma. Clin Cancer Res. 2022 Apr 14;28(8):1595-1602. doi: 10.1158/1078-0432.CCR-21-1933. PMID 35165100