RecruitingNot ApplicableNCT07627334

Personalized Targeted Glioblastoma Therapies by ex Vivo Drug Screening: Advanced Brain Tumor TheRApy Clinical Trial In Patients Scheduled for shOrt Course radiatioN

Sponsor

Medical University of Vienna

Enrollment

30 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

Patients will receive in addition to standard histology analysis also the PDC- based drug screening.

ECOG performance status 0-2
Newly diagnosed glioblastoma, IDH-wildtype - according to the 2021 WHO classification of Tumors of the Central Nervous System
Unmethylated MGMT promotor per local assessment
Successful PDC establishment and PDCs available for drug screening - based on inclusion in one of the following studies: (EK Nrs. (a) Medical University of Graz: 32-650 ex 19/20; (b) Medical University of Vienna: 1407/2021; (c) Karl Landsteiner University of Health Sciences: GS1-EK-4/823-2022; (d) Kepler University Hospital Linz: 1323/2022; (e) Medical University of Innsbruck 1003/2023) and follow-up ethics covering the establishment of an Austrian GlioBank (EK Nrs. (a) Medical University of Graz: 36-253 ex 23/24; (b) Medical University of Vienna: 2186/2023; (c) Karl Landsteiner University of Health Sciences: GS3-EK-1/211-2024; (d) Kepler University Hospital Linz: 1002/2024; (e) Medical University of Innsbruck 1095/2024)
Scheduled short-course radiotherapy with or without concomitant temozolomide
Written informed consent

Current participation in another therapeutic clinical trial.
Patients with a concurrent malignancy or malignancy within five years of study enrolment except for carcinoma in situ of the cervix, non-melanoma skin carcinoma or stage I uterine cancer within the last 3 years.
Pregnant or lactating women.
Current known infection with hepatitis B virus (HBV), or hepatitis C virus (HCV). Patients with past HBV infection or resolved HBV infection are eligible. Patients positive for anti-HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.
Known human immunodeficiency virus (HIV) infection that is not well controlled. All of the following criteria are required to define an HIV infection that is well controlled: undetectable viral RNA, CD4+ count ≥350 cells/mm3, no history of AIDS-defining opportunistic infection within the past 12 months, and stable for at least 4 weeks on the same anti-HIV medications (meaning there are no expected further changes in that time to the number or type of antiretroviral drugs in the regimen). If an HIV infection meets the above criteria, monitoring of viral RNA load and CD4+ count is recommended.
Participants who are unable or unwilling to comply with the requirements of the protocol as assessed by the investigator.

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DIAGNOSTIC_TESTCBmed drug screening platform

The main devices used within the drug screening process are purchased from PerkinElmer, Liconic Instruments, BioTek and Beckman Coulter Diagnostics

AKH Vienna, Department for Internal Medicine I, Oncology

Vienna, State of Vienna, Austria

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NCT07627334