Personalized Targeted Glioblastoma Therapies by ex Vivo Drug Screening
ConditionGlioblastoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMedical University of Vienna
About this trial
Patient derived cell line (PDC) -based drug screening will be applied to formulate a personalized treatment approach.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-75
ECOG performance status 0-2
Newly diagnosed glioblastoma, IDH wildtype - according to the 2021 WHO classification of Tumors of the Central Nervous System
MGMT promotor unmethylated per local investigator
Disqualifiers
Current participation in another therapeutic clinical trial
Patients with a concurrent malignancy or malignancy within five years prior 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 (defined as having a negative hepatitis B surface antibody [HBsAg] test and a positive anti-hepatitis B core antibody [HBcAb] test, accompanied by a negative HBV DNA test) 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
Parallel
Treatments tested in this trial
CBMed Drug Screening Plattform
Diagnostic testThe main devices used within the drug screening process are purchased from PerkinElmer, Liconic Instruments, BioTek and Beckman Coulter Diagnostics.
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: PDC-based drug screeningExperimental treatment 1 intervention
Group B: Standard groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Overall survival time
Change in overall survival in patients receiving extensive diagnostic work up including the standard histology analysis and PDC- based drug screening in addition (interventional arm) compared to patients receiving only standard histology diagnostic work up (standard arm)
Time frame
From date of randomization until date of death from any cause or last follow up whichever came first, assessed up to 144 monthsSecondary outcomes
1
Feasibility of PDC-based drug screening
Number not interpretable results of the PDC-based drug screening; Number of interpretable results of the PDC-based drug screening
Time frame
From date of randomization until date of communication of the tumor board outcome, asses up to 144 months2
Comparison of Quality of life measurements
Difference between the interventional and the standard arm using the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ- C30) and the brain cancer specific questionnaire (QLQ-BN20). The scale is from 0 to 100, with higher values reporting better quality of life.
Time frame
From date of randomization until date of death from any cause or last follow up whichever came first, assessed up to 144 months3
Comparison of neurocognitive function scale
differences in neurocognitive function between the interventional and standard arms using the Neurologic Assessment in Neuro-Oncology (NANO) scale
Time frame
From date of randomization until date of death from any cause or last follow up whichever came first, assessed up to 144 monthsSponsors and contacts
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Source ClinicalTrials.gov