Not yet recruiting NCT06804655
Pharmacoscopy for Patients With Refractory Primary Brain Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pharmacoscopy 1.0.
- Who it may be relevant to
- Registry conditions: Brain (Nervous System) Cancers, Glioblastoma, Glioma, Ependymoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device Pharmacoscopy 1.0
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.
Primary outcome measures
- To demonstrate the overall feasibility of pharmacoscopy-guided treatment for patients with refractory primary brain tumors [Time frame: 2 months]
Secondary outcome measures (9)
- To explore the efficacy of pharmacoscopy-guided treatment - 1 [Time frame: 12 months]
- To explore the efficacy of pharmacoscopy guided treatment - 2 [Time frame: 12 months]
- To explore the efficacy of pharmascopy guided treatment - 3 [Time frame: 12 months]
- To explore the efficacy of pharmascopy guided treatment - 4 [Time frame: 24 months]
- To confirm the safety and tolerability of treatment selected based on pharmacoscopy - 1 [Time frame: 12 months]
- To confirm the safety and tolerability of treatment selected based on pharmacoscopy -2 [Time frame: 12 months]
- To confirm the safety and tolerability of treatment selected based on pharmacoscopy - 3 [Time frame: 12 months]
- Quality of life -1 [Time frame: 12 months]
- Quality of life - 2 [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- 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.
- Limited systemic therapeutic options as per treating physician judgement. The number of previous lines of therapies is not limited.
- Surgery clinically indicated. A histological confirmation of the diagnosis of a recurrent brain tumor will be required before any treatment can be initiated.
- Adequate bone marrow, renal and hepatic function
- Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and return for the required assessments.
- Written informed consent for study participation must be signed and dated by the patient and the investigator prior to any study-related intervention.
Exclusion criteria
- 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.
- Judgment by the investigator that the patient should not participate in the study because the patient is unlikely to comply with study procedures, restrictions and requirements.
- Intention to become pregnant during the course of the study or pregnancy. Women of childbearing potential, including women who had their last menstruation in the last 2 years, must have a negative urinary or serum pregnancy test.
- Women who are breast feeding and who do not agree to discontinue nursing prior to the first study treatment and for the period defined in the protocol.
- Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the study.
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
- Treatment
Study locations
Switzerland · 3 centers
- University Hospital Basel — Basel
- Cantonal Hospital St Gallen — Sankt Gallen
- University Hospital Zurich — Zurich
Publications
- Lee S, Weiss T, Buhler M, Mena J, Lottenbach Z, Wegmann R, Sun M, Bihl M, Augustynek B, Baumann SP, Goetze S, van Drogen A, Pedrioli PGA, Penton D, Festl Y, Buck A, Kirschenbaum D, Zeitlberger AM, Neidert MC, Vasella F, Rushing EJ, Wollscheid B, Hediger MA, Weller M, Snijder B. High-throughput identification of repurposable neuroactive drugs with potent anti-glioblastoma activity. Nat Med. 2024 No PMID 39304781
Identifiers
NCT: NCT06804655 · EViDENCE-BT