Using ex vivo pharmacoscopy to guide treatment for brain metastases
Ex Vivo Drug Response Evaluation for Next Generation Care of Brain Metastases
This project will test whether pharmacoscopy, a lab test that screens a patient's tumor cells against many drugs, can help pick effective treatments for adults having surgery for brain metastases.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Zurich Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Basel and 2 other locations) |
| Trial ID | NCT06620380 on ClinicalTrials.gov |
What this trial studies
In this phase 2 interventional project, fresh tumor tissue obtained at surgery will be exposed ex vivo to panels of approved and experimental drugs using a pharmacoscopy platform that measures cell-specific drug responses in real time. The goal is to identify drugs that selectively kill the patient's cancer cells and could inform post‑surgical treatment choices when standard options are limited. The approach directly tests clinical material to avoid the delays and adaptations that occur with long-term cultures, and it accepts patients with brain metastases from any primary cancer. The trial builds on prior pharmacoscopy results in leukemia and preliminary reports in brain tumors but is focused on applying the method to real-time clinical decision support for brain metastases.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18) with a clinical indication for surgery and histologically confirmed brain metastases, a Karnofsky performance status of ≥60, and limited remaining systemic treatment options.
Not a fit: Patients who are not undergoing surgery, who still have effective standard targeted therapies available, who have very poor performance status, or whose surgical samples are too small or nonviable for ex vivo testing are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could personalize therapy by identifying drugs that work on an individual's brain metastasis when standard treatment options are exhausted.
How similar studies have performed: Pharmacoscopy approaches have shown clinical value in leukemia and there are early encouraging reports in brain tumors, but larger confirmatory data in brain metastases are still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients must be 18 years or older on the day of signing the informed consent, female or male. * Patients must have a Karnofsky performance status of 60 or more * Patients must have limited systemic therapeutic options as per treating physician judgement. The number of previous lines of therapies is not limited. * Patients with a tumor with a targetable oncogenic driver mutation should have already been treated with a targeted agent and options must have been exhausted. * Patients must have a clinical indication for surgery for probable brain metastasis * Patients will be considered eligible for the study only if the diagnosis of brain metastasis has been histologically confirmed on the sample obtained during the surgery performed after signing the informed consent form for the trial. * Any type of primary cancer is allowed: breast cancer, lung cancer, melanoma, other cancers. Patients may have several primary cancers. * Patients must have adequate bone marrow, renal and hepatic function documented at screening before surgery * 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 * Patients must have the 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: * Patients with rapidly progressive systemic disease * Patients with inability to undergo brain MRI evaluation. * Patients with progressive parenchymal brain metastases with an indication for requiring whole brain radiotherapy after surgery. Focal brain radiotherapy after surgery is allowed. * Judgement by the investigator that the patient is unlikely to comply with study procedures, restrictions and requirements. * Intention to become pregnant during the course of the study. * Female who are pregnant. * Female who are breastfeeding and who do not agree to discontinue nursing prior to the first treatment initiated during the study. * Sexually active males and females of childbearing potential who are not willing to use an effective contraceptive method during the study. Male participants who do not agree not to donate sperm.
Where this trial is running
Basel and 2 other locations
- University Hospital Basel — Basel, Switzerland (Not_yet_recruiting)
- Cantonal Hospital St Gallen — Sankt Gallen, Switzerland (Not_yet_recruiting)
- University Hospital Zurich — Zurich, Switzerland (Recruiting)
Study contacts
- Study coordinator: Emilie Le Rhun
- Email: emilie.lerhun@usz.ch
- Phone: +41 44 255 38 99
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.