NCT02239952

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Amsterdam UMC, location VUmc · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 patients seem to benefit from these treatment strategies. Whether these disappointing results are due to a restricted drug delivery through the blood-brain barrier, or due to differential biological characteristics of these HGGs, remains unknown. To better understand these clinical observations and to find potential insight how to overcome them, we intend to measure tumor concentrations of PKIs after approximately two weeks treatment and to determine whether these tumor concentrations correlate with plasma- and CSF concentrations of PKIs. Subsequently, we intend to determine the (phospho)proteomic profiles and kinase inhibitory activity in tumor tissue from these HGG patients after approximately two weeks of treatment with a PKI.

Conditions

• Cancer
• High-grade Glioma

Interventions

Type	Name	Description
DRUG	Sunitinib	50 mg once daily, oral use for 14 days
DRUG	vandetanib	300 mg, once daily, oral use for 14 days
DRUG	Erlotinib	150 mg, once daily, oral use for 14 days

Timeline

• Start date: 2014-11-01
• Primary completion: 2021-11-01
• Completion: 2021-11-01
• First posted: 2014-09-15
• Last updated: 2020-10-08

Locations

1 site across 1 country: Netherlands