불응 성 1 차 뇌종양 환자의 약물 검사 (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.
연구 개요
상태
개입 / 치료
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Michael Weller, Prof. Dr. med.
- 전화번호: +41442555500
- 이메일: EViDENCE-BT@usz.ch
연구 장소
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Basel-Landschaft
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Basel, Basel-Landschaft, 스위스, 4021
- 아직 모집하지 않음
- University Hospital Basel
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연락하다:
- Gregor Hutter, Prof. Dr. med.
- 전화번호: +41612657124
- 이메일: Gregor.Hutter@usb.ch
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Canton of St. Gallen
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Sankt Gallen, Canton of St. Gallen, 스위스, 9007
- 아직 모집하지 않음
- Cantonal Hospital St Gallen
-
연락하다:
- Marian Neidert, PD Dr. med.
- 전화번호: +41714941199
- 이메일: marian.neidert@kssg.ch
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Canton of Zurich
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Zurich, Canton of Zurich, 스위스, 8091
- 모병
- University Hospital Zurich
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연락하다:
- Emilie Le Rhun, PD Dr med
- 전화번호: +41442553899
- 이메일: EViDENCE-BT@usz.ch
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
To demonstrate the overall feasibility of pharmacoscopy-guided treatment for patients with refractory primary brain tumors
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
To explore the efficacy of pharmacoscopy-guided treatment - 1
기간: 12 months
|
(1) Response rate |
12 months
|
|
To explore the efficacy of pharmacoscopy guided treatment - 2
기간: 12 months
|
duration of response |
12 months
|
|
To explore the efficacy of pharmascopy guided treatment - 3
기간: 12 months
|
progression-free survival |
12 months
|
|
To explore the efficacy of pharmascopy guided treatment - 4
기간: 24 months
|
overall survival |
24 months
|
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To confirm the safety and tolerability of treatment selected based on pharmacoscopy - 1
기간: 12 months
|
Neurological function (NANO scale, Nayak et al. 2017) |
12 months
|
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To confirm the safety and tolerability of treatment selected based on pharmacoscopy -2
기간: 12 months
|
Karnofsky performance status (score 0-100) |
12 months
|
|
To confirm the safety and tolerability of treatment selected based on pharmacoscopy - 3
기간: 12 months
|
Steroid use (dose in mg equivalent dexamethasone) |
12 months
|
|
Quality of life -1
기간: 12 months
|
EORTC QLQ C30 auto-questionnaire |
12 months
|
|
Quality of life - 2
기간: 12 months
|
EORTC BN20 autoquestionnaire |
12 months
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Translational research
기간: 12 months
|
prospective assessement of the value of liquid biopsy in parallel of imaging assessment |
12 months
|
공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- EViDENCE-BT
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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