Farmakoskopi for pasienter med ildfaste primære hjernesvulster (EViDENCE-BT)
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 2
Kontakter og plasseringer
Studiekontakt
- Navn: Michael Weller, Prof. Dr. med.
- Telefonnummer: +41442555500
- E-post: EViDENCE-BT@usz.ch
Studiesteder
-
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Basel-Landschaft
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Basel, Basel-Landschaft, Sveits, 4021
- Har ikke rekruttert ennå
- University Hospital Basel
-
Ta kontakt med:
- Gregor Hutter, Prof. Dr. med.
- Telefonnummer: +41612657124
- E-post: Gregor.Hutter@usb.ch
-
-
Canton of St. Gallen
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Sankt Gallen, Canton of St. Gallen, Sveits, 9007
- Har ikke rekruttert ennå
- Cantonal Hospital St Gallen
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Ta kontakt med:
- Marian Neidert, PD Dr. med.
- Telefonnummer: +41714941199
- E-post: marian.neidert@kssg.ch
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Canton of Zurich
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Zurich, Canton of Zurich, Sveits, 8091
- Rekruttering
- University Hospital Zurich
-
Ta kontakt med:
- Emilie Le Rhun, PD Dr med
- Telefonnummer: +41442553899
- E-post: EViDENCE-BT@usz.ch
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: All patients will have their tumor analyzed by pharmacoscopy.
Therapeutic decisions will be taken considering the results of the pharmacoscopy analysis, and also standard histopathological and molecular analysis, including next generation sequencing, molecular profiling analysis as available, characteristics of the patient and previous treatments received. |
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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
To demonstrate the overall feasibility of pharmacoscopy-guided treatment for patients with refractory primary brain tumors
Tidsramme: 2 months
|
The feasibility is defined as: 80% success rate of generating a pharmacoscopy result within 10 days of surgery (32/40 patients), 50% success rate of placing patients on selected drug based on pharmacoscopy (16/32 patients). |
2 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
To explore the efficacy of pharmacoscopy-guided treatment - 1
Tidsramme: 12 months
|
(1) Response rate |
12 months
|
|
To explore the efficacy of pharmacoscopy guided treatment - 2
Tidsramme: 12 months
|
duration of response |
12 months
|
|
To explore the efficacy of pharmascopy guided treatment - 3
Tidsramme: 12 months
|
progression-free survival |
12 months
|
|
To explore the efficacy of pharmascopy guided treatment - 4
Tidsramme: 24 months
|
overall survival |
24 months
|
|
To confirm the safety and tolerability of treatment selected based on pharmacoscopy - 1
Tidsramme: 12 months
|
Neurological function (NANO scale, Nayak et al. 2017) |
12 months
|
|
To confirm the safety and tolerability of treatment selected based on pharmacoscopy -2
Tidsramme: 12 months
|
Karnofsky performance status (score 0-100) |
12 months
|
|
To confirm the safety and tolerability of treatment selected based on pharmacoscopy - 3
Tidsramme: 12 months
|
Steroid use (dose in mg equivalent dexamethasone) |
12 months
|
|
Quality of life -1
Tidsramme: 12 months
|
EORTC QLQ C30 auto-questionnaire |
12 months
|
|
Quality of life - 2
Tidsramme: 12 months
|
EORTC BN20 autoquestionnaire |
12 months
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Translational research
Tidsramme: 12 months
|
prospective assessement of the value of liquid biopsy in parallel of imaging assessment |
12 months
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i nervesystemet
- Neoplasmer etter nettsted
- Neoplasmer etter histologisk type
- Neoplasmer, kjertel og epitel
- Astrocytom
- Neoplasmer, Neuroepithelial
- Nevroektodermale svulster
- Neoplasmer, kjønnsceller og embryonale
- Neoplasmer, nervevev
- Neoplasmer i nervesystemet
- Neuroektodermale svulster, primitive
- Neoplasmer, vaskulært vev
- Meningeale neoplasmer
- Neoplasmer i sentralnervesystemet
- Patologiske tilstander, tegn og symptomer
- Tegn og symptomer
- Neoplasmer
- Nevrologiske manifestasjoner
- Glioblastom
- Glioma
- Meningioma
- Ependymom
- Medulloblastom
Andre studie-ID-numre
- EViDENCE-BT
Plan for individuelle deltakerdata (IPD)
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