Pharmacoscopy-guided treatment for refractory brain tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2 interventional study exploring pharmacoscopy, an ex vivo drug profiling approach, to guide therapy for patients with refractory primary brain tumors. Tumor tissue obtained from eligible participants will undergo pharmacoscopy to identify potentially active drugs for that individual. Treatments selected through this method will be administered under a clinical protocol, aiming to establish feasibility and guide future larger trials. The study is funded by an unrestricted grant from Anti Cancer Fund and involves multiple Swiss centers, including the University of Zurich and partner hospitals. Eligibility includes adults with confirmed recurrent brain tumors, adequate organ function, and limited systemic treatment options.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18 years or older on day of signing informed consent, female or male.
2. 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.
3. Karnofsky performance status of 60 or more
4. Life expectancy \>12 weeks.
5. Limited systemic therapeutic options as per treating physician judgement. The number of previous lines of therapies is not limited.
6. Surgery clinically indicated. A histological confirmation of the diagnosis of a recurrent brain tumor will be required before any treatment can be initiated.
7. Adequate bone marrow, renal and hepatic function
8. 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.
9. 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:

1. Inability to undergo brain or spine MRI.
2. Concurrent treatment with other systemic tumor-directed pharmacotherapies.
3. Intent to be treated with radiotherapy.
4. Any investigational antitumor therapy other than those under investigation in this study.
5. 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.
6. 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.
7. 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.
8. Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the study.

Where it's running

• University Hospital Zurich
  Zurich, Canton of Zurich, Switzerland Recruiting
• University Hospital Basel
  Basel, Basel-Landschaft, Switzerland Not yet recruiting
• Cantonal Hospital St Gallen
  Sankt Gallen, Canton of St. Gallen, Switzerland Not yet recruiting

Study contacts

• Study coordinator: Michael Weller, Prof. Dr. med.
• Email: EViDENCE-BT@usz.ch
• Phone: +41442555500

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.