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

Фаза 1 Идёт, набор закрыт NCT02192359

Заболевание	Recurrent Anaplastic Astrocytoma, Recurrent Anaplastic Oligoastrocytoma, Recurrent Anaplastic Oligodendroglioma, Recurrent Glioblastoma
Фаза	Фаза 1
Спонсор	City of Hope Medical Center
Статус	Идёт, набор закрыт
Участники	18 участн.
Вмешательство	Carboxylesterase-expressing Allogeneic Neural Stem Cells, Irinotecan, Irinotecan Hydrochloride, Laboratory Biomarker Analysis, Pharmacological Study
Дата начала	5.04.2016
Дата завершения	21.02.2022
Публикация результатов	29.04.2024

Кратко

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

Открыть в BENITIONS Открыть на ClinicalTrials.gov

Другие исследования по этому заболеванию

Solriamfetol in Improving Sleep in Patients With Grade II-IV Glioma — Wake Forest University Health Sciences
Temozolomide With or Without Veliparib in Treating Patients With Newly Diagnosed Glioblast — National Cancer Institute (NCI)
TORC1/2 Inhibitor MLN0128 and Bevacizumab in Treating Patients With Recurrent Glioblastoma — National Cancer Institute (NCI)
Genetically Modified T-cells in Treating Patients With Recurrent or Refractory Malignant G — City of Hope Medical Center
Phase II Study of BKM120 for Subjects With Recurrent Glioblastoma — L. Nicolas Gonzalez Castro, MD, PhD
A Safety Study of Pharmacologic Ascorbate and Ferumoxytol in Addition to Standard of Care — Bryan Allen

Все исследования

Страница обобщает открытые данные ClinicalTrials.gov. Это не медицинская и не инвестиционная рекомендация. Обратитесь к врачу.

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