Intratumorally-Administered Topotecan Using CED in High Grade Glioma Undergoing Stereotactic Biopsy
2019年2月28日 更新者：Michael Vogelbaum, MD, PhD
Pilot Trial of Intratumorally-Administered Topotecan Using Convection-Enhanced Delivery (CED) in Patients With Suspected Recurrent/Progressive World Health Organization (WHO) Grade III or IV (High Grade) Glioma Undergoing Stereotactic Biopsy (IND 117,240)
The purpose of this study is to determine if treatment with topotecan by an alternative method, direct delivery into brain tumors, is safe and well tolerated. The Cleveland Multiport Catheter is a new, investigational device that will be used to deliver topotecan into your brain tumor. A second purpose of this study is to determine whether the Cleveland Multiport Catheter can be used effectively and safely to deliver topotecan into your brain tumor.
This study will also determine the best dose of topotecan to deliver to your tumor with use of the Cleveland Multiport Catheter and will also examine how your tumor responds to treatment with topotecan.
調査の概要
状態
引きこもった
条件
詳細な説明
Primary Objectives
- To investigate by MR imaging the spatial and temporal distribution of topotecan in enhancing or nonenhancing bulk tumor administered by convection-enhanced delivery (CED) in patients with recurrent/progressive WHO grade III or IV (high grade) glioma (HGG) who have failed standard therapy comprising surgical biopsy and/or resection and adjuvant chemotherapy and radiotherapy.
- To investigate by MR imaging the influence of the rate and topotecan concentration, on the spatial and temporal distribution of topotecan administered by CED in patients with with recurrent/progressive HGG
Secondary Objectives
- To investigate the extent to which backflow may be observed on MRI during CEDmediated delivery of topotecan
- To assess the safety, tolerability and toxicity profile of topotecan administered by CED using different doses and infusion rates.
- To observe evidence of activity of single-agent topotecan administered by CED to patients with recurrent/progressive HGG who have failed standard therapy comprising surgical biopsy and/or resection and adjuvant chemotherapy and radiotherapy.
研究の種類
介入
段階
- 初期フェーズ 1
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Histologically confirmed diagnosis of supratentorial WHO Grade III or IV Glioma (High Grade Glioma) that has undergone surgical biopsy or resection followed by adjuvant chemoradiotherapy, that has evidence of recurrence or progression based on imaging studies and a stereotactic biopsy is indicated for confirmation of recurrence/progression
- Karnofsky Performance Status 70-100
- MRI demonstration of a stereotactically accessible enhancing mass that does not require resection to relieve clinically significant mass effect
- Patient understands the procedures and agrees to comply with the study requirements by providing written informed consent
Laboratory values within the following ranges:
- Absolute neutrophil count (ANC) ≥ 1,500 / μL
- Platelet count ≥ 100,000 / μL
- Hemoglobin ≥ 10 g / dL
- prothrombin time (PT) / partial thromboplastin time (PTT) not above institutional norms
- Estimated glomerular filtration rate (eGFR) of at least 50 mL/min
Exclusion Criteria:
- Patient is mentally or legally incapacitated at the time of the study
- Known HIV(+) or has been diagnosed with AIDS
- Participation in another investigational drug study in the prior 4 weeks
- Positive pregnancy test in a female
- Patient, in the opinion of the investigator, is likely to be poorly compliant
- Diffuse subependymal or cerebrospinal fluid (CSF) disease
- Tumors involving the cerebellum
- Tumor enhancement involving both hemispheres
- Active infection requiring treatment
- Unexplained febrile illness
- Radiation or chemotherapy within 4 weeks of enrollment
- Systemic diseases associated with unacceptable anesthesia or operative risk
- Inability to undergo magnetic resonance imaging
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：非ランダム化
- 介入モデル：並列代入
- 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：Predominantly enhancing mass with volume of 8 cc or less
Only 1 Cleveland Multiport Catheter (CMC) will be placed and CED will be performed intra-operatively only in a magnetic resonance imaging (MRI) equipped Operating Room.
Topotecan infusion will be performed over a 4-hour period, with the goal of complete tumor coverage.
The initial rate will be 1.20 ml/hour and infusion will be monitored by intermittent MRI imaging.
The rate may be adjusted upwards during the infusion, in the event of incomplete tumor coverage, or downwards, if new mass effect is apparent.
Following completion of the 4-hour infusion, the CMC will be removed.
The initial rate for each subsequent patient may be adjusted upwards in increments of up to 1.20 ml/hour based upon the tumor coverage and safety characteristics of the previously treated patients.
|
In predominantly enhancing mass with a volume of 8 cc or less of topotecan administered
他の名前：
an investigational device, will be used to deliver the topotecan
to monitor the infusion of topotecan into the tumor
|
|
実験的：Predominantly enhancing mass with volume of > 8 cc
2 Cleveland Multiport Catheter (CMCs) will be placed and the total infusion rate of Topotecan per CMC to be used for the first 24 hours for the first patient will be 0.834 ml/hour (3.48 microliters/minute/microcatheter).
The rate used for the second 24 hours of the infusion will be 1.668 ml/hour.
If the first patient does not experience rate-limiting toxicity, then the patient #2's initial infusion rate will start at the highest tolerated rate for patient #1, and the second 24-hour rate for that patient will be increased by 0.834 ml/hour.
Each subsequent patient will undergo rate escalation in a similar manner until we observe either: 1) complete coverage of the enhancing tumor by the infused Gadopentetic acid (Gd-DTPA), or 2) rate-limiting toxicity.
|
an investigational device, will be used to deliver the topotecan
to monitor the infusion of topotecan into the tumor
In predominantly enhancing mass with a volume of > 8 cc of topotecan administered.
Initial rate is 0.834ml/hour with an increase to 1.668 ml/hour at the second infusion
他の名前：
|
|
実験的：Predominantly non-enhancing mass
The total infusion rate of Topotecan per Cleveland Multiport Catheter (CMC) to be used for the first 24 hours for the first patient will be 0.29 ml/hour.
The rate used for the second 24 hours of the infusion will be 0.58 ml/hour.
If the first patient does not experience rate-limiting toxicity, then the patient #2's initial infusion rate will start at the highest tolerated rate for patient #1, and the second 24-hour rate for that patient will be increased by 0.29 ml/hour.
Each subsequent patient will undergo rate escalation in a similar manner until we observe either: 1) complete coverage of the non-enhancing tumor by the infused Gd-DTPA, or 2) rate-limiting toxicity.
|
an investigational device, will be used to deliver the topotecan
to monitor the infusion of topotecan into the tumor
Rate for non-enhancing tumors has an initial dose of 0.29ml/hour
他の名前：
|
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 |
|---|---|---|
|
Number of intra-operative catheter related complications
時間枠：Up to 12 months
|
Documentation of possible, probable, or definite catheter-related complications
|
Up to 12 months
|
|
Number of post-operative catheter related complications
時間枠：Up to 12 months
|
Documentation of possible, probable, or definite catheter-related complications
|
Up to 12 months
|
|
Number of catheter related complications after catheter removal
時間枠：Up to 12 months
|
Documentation of possible, probable, or definite catheter-related complications
|
Up to 12 months
|
|
Change in the spatial distribution of intratumorally-administered topotecan at serial timepoints using a gadolinium-based contrast agent, as determined by MRI scan
時間枠：Up to 12 months
|
Up to 12 months
|
|
|
Changes in the spatial distribution of intratumorally-administered topotecan associated with changes in the infusion rate, as determined by MRI scan
時間枠：Up to 12 months
|
Up to 12 months
|
|
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Changes in the spatial distribution of intratumorally-administered topotecan at serial timepoints using volumetric magnetic resonance imaging, as determined by MRI scan
時間枠：Up to 12 months
|
Up to 12 months
|
|
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Changes in the spatial distribution of intratumorally-administered topotecan at serial timepoints using three-dimensional image reconstruction, as determined by MRI scan
時間枠：Up to 12 months
|
Up to 12 months
|
|
|
Changes in the spatial distribution of intratumorally-administered topotecan associated with changes in the infusion concentration, as determined by MRI scan
時間枠：Up to 12 months
|
Up to 12 months
|
|
|
Changes in the spatial distribution of intratumorally-administered topotecan associated with changes in the infusion duration, as determined by MRI scan
時間枠：Up to 12 months
|
Up to 12 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants with response as measured by the Response Assessment in Neuro-Oncology (RANO) Criteria
時間枠：Up to 12 months
|
Response includes objective response rate (ORR), median progression-free survival (PFS), proportion progression-free at six months (PFS-6), and median overall survival (OS)
|
Up to 12 months
|
|
Safety as measured by the common terminology criteria for adverse events (CTCAE)
時間枠：Up to 12 months
|
Safety will be determined through adverse events by arm
|
Up to 12 months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Michael A. Vogelbaum, MD, PhD、Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2017年11月3日
一次修了 (実際)
2018年11月19日
研究の完了 (実際)
2018年11月19日
試験登録日
最初に提出
2017年6月13日
QC基準を満たした最初の提出物
2017年6月17日
最初の投稿 (実際)
2017年6月20日
学習記録の更新
投稿された最後の更新 (実際)
2019年3月1日
QC基準を満たした最後の更新が送信されました
2019年2月28日
最終確認日
2019年2月1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
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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
はい
米国FDA規制機器製品の研究
はい
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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