Personalized Targeted Glioblastoma Therapies Guided by Ex Vivo Drug Screening

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study uses a patient-derived cell (PDC) drug-screening platform in addition to standard histology for newly diagnosed IDH-wildtype glioblastoma. A molecular tumor board will translate the ex vivo screening results into a personalized treatment recommendation, which will be communicated to the patient. The trial assesses feasibility and potential benefits of tailoring adjuvant or maintenance therapy to fit a reduced radiotherapy course with systemic therapy when possible. Enrollment requires successful PDC establishment and adherence to an approved performance study plan with informed consent and authorized investigators. Geographic and institutional collaboration is limited to the Medical University of Vienna and affiliated Austrian sites, with radiotherapy being a planned component of care.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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
* No exclusion criteria

Exclusion Criteria:

* 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.

Where it's running

• AKH Vienna, Department for Internal Medicine I, Oncology
  Vienna, State of Vienna, Austria Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.