Pharmacoscopy refers to an ex vivo real-time drug sensitivity profiling platform that has been shown to be of value in the treatment of leukemia (Snijder et al. 2017) (Kornauth et al. 2022) and may help to identify novel treatment opportunities for brain tumors as well (Lee et al. 2022). The rationale for pharmacoscopy-based drug sensitivity testing on real-time patient biopsies or surgery material is multiple: measuring drug response and sensitivity directly in real-time patient material, overcomes the problem of limited molecular biomarkers for established targeted therapeutic options and can identify effective drugs even for non-targeted therapies such as chemotherapy. It can also identify hitherto unknown specific vulnerabilities of cancer cells. Furthermore, testing directly on patient material overcomes the limitations of patient-derived cell cultures, organoids, and patient xenografts, as their prolonged culture times risk cellular adaptations and clonal selection that alter drug sensitivity. Pharmacoscopy maintains the tumor cell composition, including bystander cells or tumor microenvironment, and limits cell culture to max 48 hours. Furthermore, pharmacoscopy measures drug responses on a single-cell and on a high-content level, uniquely allowing to measure the drug sensitivity of tumor cells, and allowing to compare it to the drug cytotoxicity on healthy cells from the same patient. This relative readout has previously been shown to be essential for the correct prediction of a clinical response in haematological malignancies (Snijder et al. 2017) (Kornauth et al. 2022). The aim of this study is to generate preliminary data regarding superiority of the personalized pharmacoscopy-guided approach compared to a standard non-pharmacoscopy-guided approach, in patients with brain metastases with an indication for surgery, and limited therapeutic systemic options according to the treating physician.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
102
Pharmacoscopy is currently an academically developed platform. The study is designed to investigate the clinical performance of this academic platform. In the interventional arm, the best candidate agent defined by pharmascopy will be considered to guide the therapeutic decision for each patient.
The next systemic treatment after surgery will be discussed, with the investigator and at the tumor board, considering also standard histopathological and molecular analysis, including next generation sequencing, molecular profiling analysis and previous treatments received
University Hospital Basel
Basel, Switzerland
RECRUITINGCantonal Hospital St Gallen
Sankt Gallen, Switzerland
NOT_YET_RECRUITINGUniversity Hospital Zurich
Zurich, Switzerland
RECRUITINGOverall survival
Time frame: 8 months
Response assessment
(A) in all patients: type of response; correlation of the type of response between CNS and extra-CNS compartments (B) in patients with measurable disease: type and duration of response; correlation of response rate between CNS and extra-CNS compartments.
Time frame: 8 months
Progression free survival
Time frame: 8 months
Quality of life and neurological status 1
EORTC-QLQ C30 scale
Time frame: 8 months
Quality of life and neurological status 2
EORTC BN20 scale
Time frame: 8 months
Quality of life and neurological status 3
NANO scale (Neurological Assessment in Neuro-Oncology)
Time frame: 8 months
Quality of life and neurological status 4
Response assessement in Neuro-Oncology (RANO) seizure scale
Time frame: 8 months
Quality of life and neurological status 5
Karnofsky performance status scale
Time frame: 8 months
Steroid use
Consumption of steroids during the study
Time frame: 8 months
Pharmacoscopy assessment 1
rate of interpretable pharmacoscopy results, in the pharmacoscopy arm only
Time frame: 1 month
Pharmacoscopy assessment 2
description of potential causes of failure of the pharmacoscopy analysis, in the pharmacoscopy arm only
Time frame: 1 month
Pharmacoscopy assessment 3
rate of indication of pharmacoscopy guided-treatment, in the pharmacoscopy arm only
Time frame: 1 month
Pharmacoscopy assessment 4
access to the preferred drug selected by the pharmacoscopy, in the pharmacoscopy arm only
Time frame: 1 month
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.