BENITIONSClinical Trial Intelligence

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
分期1期
申办方City of Hope Medical Center
状态进行中(已停止招募)
受试者人数18 人
干预(药物)Carboxylesterase-expressing Allogeneic Neural Stem Cells, Irinotecan, Irinotecan Hydrochloride, Laboratory Biomarker Analysis, Pharmacological Study
开始日期2016年4月5日
完成日期2022年2月21日
结果公布日2024年4月29日

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
Dose Level 2: 5x10^7 (2 Doses)0 Participants
Dose Level 3: 1x10^8 (2 Doses)0 Participants
Dose Level 4: 1.5x10^8 (2 Doses)1 Participants

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
Dose Level 2: 5x10^7 (2 Doses)0 Participants
Dose Level 3: 1x10^8 (2 Doses)0 Participants
Dose Level 4: 1.5x10^8 (2 Doses)0 Participants

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
Dose Level 2: 5x10^7 (2 Doses)0 Participants
Dose Level 3: 1x10^8 (2 Doses)1 Participants
Dose Level 4: 1.5x10^8 (2 Doses)0 Participants
Dose Level 1: 5x10^7 (1 Dose)4 Participants
Dose Level 2: 5x10^7 (2 Doses)3 Participants

在 BENITIONS 中查看 查看 ClinicalTrials.gov 原文

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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。