Pharmacoscopy for Patients With Refractory Primary Brain Tumors

Обзор

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• To demonstrate the overall feasibility of pharmacoscopy-guided treatment for patients with refractory primary brain tumors [Срок оценки: 2 months]

Вторичные конечные точки (9)

• To explore the efficacy of pharmacoscopy-guided treatment - 1 [Срок оценки: 12 months]
• To explore the efficacy of pharmacoscopy guided treatment - 2 [Срок оценки: 12 months]
• To explore the efficacy of pharmascopy guided treatment - 3 [Срок оценки: 12 months]
• To explore the efficacy of pharmascopy guided treatment - 4 [Срок оценки: 24 months]
• To confirm the safety and tolerability of treatment selected based on pharmacoscopy - 1 [Срок оценки: 12 months]
• To confirm the safety and tolerability of treatment selected based on pharmacoscopy -2 [Срок оценки: 12 months]
• To confirm the safety and tolerability of treatment selected based on pharmacoscopy - 3 [Срок оценки: 12 months]
• Quality of life -1 [Срок оценки: 12 months]
• Quality of life - 2 [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Швейцария · 3 центра

• University Hospital Basel — Basel
• Cantonal Hospital St Gallen — Sankt Gallen
• University Hospital Zurich — Zurich

Публикации

• 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

Идентификаторы

NCT: NCT06804655 · EViDENCE-BT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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