Carboxylesterase-Expressing Allogeneic Neural Stem Cells and Irinotecan Hydrochloride in Treating Patients With Recurrent High-Grade Gliomas
1期
进行中(已停止招募)
NCT02192359
| 适应症 | Recurrent Anaplastic Astrocytoma, Recurrent Anaplastic Oligoastrocytoma, Recurrent Anaplastic Oligodendroglioma, Recurrent Glioblastoma |
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| 分期 | 1期 |
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| 申办方 | City of Hope Medical Center |
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| 状态 | 进行中(已停止招募) |
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| 受试者人数 | 18 人 |
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| 干预(药物) | Carboxylesterase-expressing Allogeneic Neural Stem Cells, Irinotecan, Irinotecan Hydrochloride, Laboratory Biomarker Analysis, Pharmacological Study |
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| 开始日期 | 2016年4月5日 |
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| 完成日期 | 2022年2月21日 |
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| 结果公布日 | 2024年4月29日 |
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摘要
This phase I trial studies the side effects and best dose of carboxylesterase-expressing allogeneic neural stem cells when given together with irinotecan hydrochloride in treating patients with high-grade gliomas that have come back. Placing genetically modified neural stem cells into brain tumor cells may make the tumor more sensitive to irinotecan hydrochloride. Irinotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving carboxylesterase-expressing allogeneic neural stem cells and irinotecan hydrochloride may be a better treatment for high-grade gliomas.
Number of Participants Experiencing a Dose-limiting Toxicity (DLT)
28 days post first dose of NSC treatment on day 1, cycle 1 · Participants
| Dose Level 1: 5x10^7 (1 Dose) | 0 Participants |
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| Dose Level 2: 5x10^7 (2 Doses) | 0 Participants |
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| Dose Level 3: 1x10^8 (2 Doses) | 0 Participants |
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| Dose Level 4: 1.5x10^8 (2 Doses) | 1 Participants |
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Number of Participants With Grade 3 or Higher Toxicity Profile Attributed to NSCs
Followed 30 days post treatment for all toxicities (min=33,max 142 days), up to 5 years for gene therapy toxicities · Participants
| Dose Level 1: 5x10^7 (1 Dose) | 0 Participants |
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| Dose Level 2: 5x10^7 (2 Doses) | 0 Participants |
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| Dose Level 3: 1x10^8 (2 Doses) | 0 Participants |
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| Dose Level 4: 1.5x10^8 (2 Doses) | 0 Participants |
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Number of Participants With Grade 3 or Higher Toxicity Profile Attributed to Irinotecan
Followed 30 days post treatment for all toxicities (min=33,max 142 days), up to 5 years for gene therapy toxicities · Participants
| Dose Level 1: 5x10^7 (1 Dose) | 0 Participants |
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| Dose Level 2: 5x10^7 (2 Doses) | 0 Participants |
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| Dose Level 3: 1x10^8 (2 Doses) | 1 Participants |
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| Dose Level 4: 1.5x10^8 (2 Doses) | 0 Participants |
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| Dose Level 1: 5x10^7 (1 Dose) | 4 Participants |
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| Dose Level 2: 5x10^7 (2 Doses) | 3 Participants |
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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。