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

ConditionGlioblastoma (GBM)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorMedical University of Vienna

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • CBmed drug screening platform

    Diagnostic test

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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: ex vivo drug screeningOther 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of patients

Percentage of patients receiving at least one day of maintenance systemic therapy in the timeframe of 4-6 weeks after completion of a short course radio(-chemo)therapy (40 Gy in 15 fractions)

Time frame
From date of enrollment until the last follow up or the date of death from any causes, whichever came first, assessed up to 3 years

Secondary outcomes

1

PDC-based drug screening

Assess feasibility of a PDC-based drug screening approach in a multi-center study hroughout Austria and within the timeframe short course radio(-chemo)therapy (40 Gy in 15 fractions)

Time frame
From date of enrollment until the last follow up or the date of death from any causes, whichever came first, assessed up to 3 years
2

Quality of life assessment

Quality of life assessment based on verified questionnaires

Time frame
From date of enrollment until the last follow up or the date of death from any causes, whichever came first, assessed up to 3 years
3

Neurocognitive function

Assess the neurocognitive function using the NANO scale (neurological assessment in neuro- oncology)

Time frame
From date of enrollment until the last follow up or the date of death from any causes, whichever came first, assessed up to 3 years
4

Overall survival

Assess the overall survival

Time frame
From date of enrollment until the last follow up or the date of death from any causes, whichever came first, assessed up to 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of Vienna

Lead sponsor

Source ClinicalTrials.gov
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