難治性原発性脳腫瘍の患者の薬心鏡検査 (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.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Michael Weller, Prof. Dr. med.
- 電話番号：+41442555500
- メール：EViDENCE-BT@usz.ch
研究場所
-
-
Basel-Landschaft
-
Basel、Basel-Landschaft、スイス、4021
- まだ募集していません
- University Hospital Basel
-
コンタクト：
- Gregor Hutter, Prof. Dr. med.
- 電話番号：+41612657124
- メール：Gregor.Hutter@usb.ch
-
-
Canton of St. Gallen
-
Sankt Gallen、Canton of St. Gallen、スイス、9007
- まだ募集していません
- Cantonal Hospital St Gallen
-
コンタクト：
- Marian Neidert, PD Dr. med.
- 電話番号：+41714941199
- メール：marian.neidert@kssg.ch
-
-
Canton of Zurich
-
Zurich、Canton of Zurich、スイス、8091
- 募集
- University Hospital Zurich
-
コンタクト：
- Emilie Le Rhun, PD Dr med
- 電話番号：+41442553899
- メール：EViDENCE-BT@usz.ch
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
To demonstrate the overall feasibility of pharmacoscopy-guided treatment for patients with refractory primary brain tumors
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
To explore the efficacy of pharmacoscopy-guided treatment - 1
時間枠：12 months
|
(1) Response rate |
12 months
|
|
To explore the efficacy of pharmacoscopy guided treatment - 2
時間枠：12 months
|
duration of response |
12 months
|
|
To explore the efficacy of pharmascopy guided treatment - 3
時間枠：12 months
|
progression-free survival |
12 months
|
|
To explore the efficacy of pharmascopy guided treatment - 4
時間枠：24 months
|
overall survival |
24 months
|
|
To confirm the safety and tolerability of treatment selected based on pharmacoscopy - 1
時間枠：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
時間枠：12 months
|
Karnofsky performance status (score 0-100) |
12 months
|
|
To confirm the safety and tolerability of treatment selected based on pharmacoscopy - 3
時間枠：12 months
|
Steroid use (dose in mg equivalent dexamethasone) |
12 months
|
|
Quality of life -1
時間枠：12 months
|
EORTC QLQ C30 auto-questionnaire |
12 months
|
|
Quality of life - 2
時間枠：12 months
|
EORTC BN20 autoquestionnaire |
12 months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Translational research
時間枠：12 months
|
prospective assessement of the value of liquid biopsy in parallel of imaging assessment |
12 months
|
協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- EViDENCE-BT
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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