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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
40
The 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.
University Hospital Basel
Basel, Basel-Landschaft, Switzerland
Cantonal Hospital St Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland
University Hospital Zurich
Zurich, Canton of Zurich, Switzerland
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).
Time frame: 2 months
To explore the efficacy of pharmacoscopy-guided treatment - 1
(1) Response rate
Time frame: 12 months
To explore the efficacy of pharmacoscopy guided treatment - 2
duration of response
Time frame: 12 months
To explore the efficacy of pharmascopy guided treatment - 3
progression-free survival
Time frame: 12 months
To explore the efficacy of pharmascopy guided treatment - 4
overall survival
Time frame: 24 months
To confirm the safety and tolerability of treatment selected based on pharmacoscopy - 1
Neurological function (NANO scale, Nayak et al. 2017)
Time frame: 12 months
To confirm the safety and tolerability of treatment selected based on pharmacoscopy -2
Karnofsky performance status (score 0-100)
Time frame: 12 months
To confirm the safety and tolerability of treatment selected based on pharmacoscopy - 3
Steroid use (dose in mg equivalent dexamethasone)
Time frame: 12 months
Quality of life -1
EORTC QLQ C30 auto-questionnaire
Time frame: 12 months
Quality of life - 2
EORTC BN20 autoquestionnaire
Time frame: 12 months
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