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NCT02192359 · ClinicalTrials.gov registry record · Phase 1
Carboxylesterase-Expressing Allogeneic Neural Stem Cells and Irinotecan Hydrochloride in Treating Patients With Recurrent High-Grade Gliomas
A Phase 1 study of Recurrent Glioblastoma and Recurrent Malignant Glioma, sponsored by City of Hope Medical Center.
- Active
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT02192359: Active Phase 1 study of Recurrent Glioblastoma and Recurrent Malignant Glioma, sponsored by City of Hope Medical Center.
NCT02192359 is a Phase 1 study of Recurrent Glioblastoma and Recurrent Malignant Glioma that is active but no longer recruiting, run by City of Hope Medical Center. The registered enrollment target is 18 participants, below the 69-participant average among 62 other Recurrent Glioblastoma trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02192359, a Phase 1 study of Recurrent Glioblastoma and Recurrent Malignant Glioma, is active but no longer recruiting, sponsored by City of Hope Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Toxicities will be graded using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. A DLT is defined as an adverse event that is related to the administration of NSCs and/or irinotecan, occurs during the first treatment cycle and meets any of the following: 1. Received less than 80% of study treatments except due to CNS toxicity 2. Grade 4 thrombocytopenia or anemia or neutropenia lasting \> 7 days 3. Febrile neutropenia with ANC \< 0.5 x10\^9/L 4. Grade 3 central nervous sy
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Irinotecan
- DRUG Irinotecan Hydrochloride
- OTHER Pharmacological Study
- BIOLOGICAL Carboxylesterase-expressing Allogeneic Neural Stem Cells
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2016-03-07 |
| Est. Completion | 2026-09-25 |
| Phase | Phase 1 |
What the registry record for NCT02192359 still lists
NCT02192359 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 69-participant average among 62 other Recurrent Glioblastoma trials with a reported enrollment target (74% lower).
The record links to 7 conditions, with Recurrent Glioblastoma appearing as the primary indexed condition, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02192359 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT02192359 about?
NCT02192359 is a clinical study titled "Carboxylesterase-Expressing Allogeneic Neural Stem Cells and Irinotecan Hydrochloride in Treating Patients With Recurrent High-Grade Gliomas". 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 ce...
What is the current status of trial NCT02192359?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2016-03-07. Estimated completion is 2026-09-25.
What conditions does trial NCT02192359 study?
This clinical trial studies the following conditions: Recurrent Glioblastoma, Recurrent Malignant Glioma, Recurrent Gliosarcoma, Recurrent WHO Grade III Glioma, Recurrent Anaplastic Astrocytoma.
What interventions are being tested in trial NCT02192359?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Irinotecan (DRUG), Irinotecan Hydrochloride (DRUG), Pharmacological Study (OTHER), Carboxylesterase-expressing Allogeneic Neural Stem Cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT02192359?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02192359 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02192359's enrollment target sits among peer trials
18 48th of 62 higher than 13 of 62 other Recurrent Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Glioblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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