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

Overview

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

Detailed description

Patients will receive in addition to standard histology analysis also the PDC- based drug screening. The PDC-based drug screening will be performed only in accordance with the approved Performance Study Plan on subjects who have signed an informed consent form. Execution of the PDC-based drug screening is limited to the approved study investigators. Based on the results of the PDC-based drug screening, a molecular tumor board will formulate a personalized treatment approach. The personalized treatment recommendation will be communicated to the patient. Application of adjuvant

/ maintenance therapy will be evaluated to evaluate the proportion of patients scheduled for a reduced course of radio(-chemo)therapy fit enough to receive at least one day of systemic therapy.

Interventions

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

Primary outcome measures

• Percentage of patients [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 outcome measures (6)

• PDC-based drug screening [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]
• Quality of life assessment [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]
• Neurocognitive function [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]
• 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]
• Progression free 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]
• Geriatric screening tools [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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Other

Study locations

Austria · 1 center

• AKH Vienna, Department for Internal Medicine I, Oncology — Vienna

Identifiers

NCT: NCT07627334 · ATTRACTION

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗