Carboxylesterase-Expressing Allogeneic Neural Stem Cells and Irinotecan Hydrochloride in Treating Patients With Recurrent High-Grade Gliomas
Phase 1
Active, not recruiting
NCT02192359
| Condition | Recurrent Anaplastic Astrocytoma, Recurrent Anaplastic Oligoastrocytoma, Recurrent Anaplastic Oligodendroglioma, Recurrent Glioblastoma |
|---|
| Phase | Phase 1 |
|---|
| Sponsor | City of Hope Medical Center |
|---|
| Status | Active, not recruiting |
|---|
| Enrollment | 18 participants |
|---|
| Interventions | Carboxylesterase-expressing Allogeneic Neural Stem Cells, Irinotecan, Irinotecan Hydrochloride, Laboratory Biomarker Analysis, Pharmacological Study |
|---|
| Start date | Apr 5, 2016 |
|---|
| Completion date | Feb 21, 2022 |
|---|
| Results posted | Apr 29, 2024 |
|---|
Summary
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 |
|---|
Open in BENITIONS
View on ClinicalTrials.gov
Other trials for this condition
All trials
This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.