Advanced technology of ex vivo drug profiling referred to as pharmacoscopy may allow to identify novel drugs for the treatment of glioblastoma and other refractory brain tumors at an individual patient level. This personalized therapeutic approach was developed and validated in pre-clinical glioma models. With the current research proposal, we seek to establish feasibility for a clinical interventional trial for patients with refractory primary brain tumors that is based on pharmacoscopy-guided selection of treatment.
The study is supported by an unrestricted grant from Anti Cancer Fund.
Age 18 years or older on day of signing informed consent, female or male.
Refractory glioblastoma, isocitrate dehydrogenase (IDH)-mutant astrocytoma or oligodendroglioma, histone-mutant glioma, ependymoma, medulloblastoma, meningioma or other rare primary brain tumor with a histological confirmation according to the WHO classification 2021. Primary tumors can be located at the cerebral or spinal level. Primary brain tumors with metastases outside of the brain may also be considered.
Karnofsky performance status of 60 or more
Life expectancy >12 weeks.
Inability to undergo brain or spine MRI.
Concurrent treatment with other systemic tumor-directed pharmacotherapies.
Intent to be treated with radiotherapy.
Any investigational antitumor therapy other than those under investigation in this study.
Single group
Pharmacoscopy 1.0
DeviceThe intervention is the submission of freshly obtained surgical material to ex vivo drug profiling which we term pharmacoscopy (PCY). The performance study is interventional as the test results shall influence patient management decisions and/or may be used to guide treatment.
To demonstrate the overall feasibility of pharmacoscopy-guided treatment for patients with refractory primary brain tumors
The feasibility is defined as: 80% success rate of generating a pharmacoscopy result within 10 days of surgery (32/40 patients), 50% success rate of placing patients on selected drug based on pharmacoscopy (16/32 patients).
To explore the efficacy of pharmacoscopy-guided treatment - 1
(1) Response rate
To explore the efficacy of pharmacoscopy guided treatment - 2
duration of response
To explore the efficacy of pharmascopy guided treatment - 3
progression-free survival
To explore the efficacy of pharmascopy guided treatment - 4
overall survival
Translational research
prospective assessement of the value of liquid biopsy in parallel of imaging assessment
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University of Zurich
Lead sponsor
University Hospital, Zürich
Collaborator
University Hospital, Basel, Switzerland
Collaborator
Cantonal Hospital of St. Gallen
Collaborator
