The goal of this Phase 0 trial is to study if pre-operative oral pitavastatin administration reaches the tumour in patients with primary or a recurrent glioblastoma. The main question\[s\] it aims to answer are: * Does pitavastatin reach a cytotoxic concentration in gadolinium-enhanced tumour tissue after oral administration? * Does pitavastatin achieve a concentration that can synergize with temozolomide in the gadolinium non-enhanced area of the tumour? Participants will receive pitavastatin in differing dosages a week before their elective surgery and blood and tumour samples will be collected.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
12
Daily Pitavastatin administration
Erasmus MC
Rotterdam, Netherlands
Intratumoral pitavastatin concentration as assessed by LC-MS analysis on tumour tissue.
Detection of pitavastatin in gadolinium enhanced and gadolinium non-enhanced tumour. tissue in relation to serum levels after preoperative administration.
Time frame: From the last patient visit of each dose cohort at day 9 to 2 weeks after the last patient visit of each dose cohort.
Tolerability of short-term pitavastatin treatment as assesseb by a customized questionnaire related to adverse events found during the use of pitavastatin.
Number of AEs, SAEs and SUSARs collected at the end of the trial. Events will be scored according to CTC criteria version 5.0 (Published November 27th, 2017).
Time frame: From the last patient visit of the last dose cohort to 2 weeks after the last patient visit of the last dose cohort on day 9.
Relation of plasma pitavastatin concentration and intratumoral pitavastatin concentration as assessed by LC-MS analysis on plasma and tumour tissue.
Correlation of pitavastatin concentration in plasma to pitavastatin concentration in different tumour sites(gadolinium enhanced, gadolinium non-enhanced and tumour periphery).
Time frame: From the moment the LC-MS analysis of the last patient tumour tissue and plasma is performed to two weeks after the last patient visit on day 9 of the last dose cohort.
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