Carboxylesterase-Expressing Allogeneic Neural Stem Cells and Irinotecan Hydrochloride in Treating Patients With Recurrent High-Grade Gliomas

1상 진행 중(모집 완료) NCT02192359

요약

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

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

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

BENITIONS에서 보기 ClinicalTrials.gov 원문 보기

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