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NCT02015819 · ClinicalTrials.gov registry record · Phase 1
Genetically Modified Neural Stem Cells, Flucytosine, and Leucovorin for Treating Patients With Recurrent High-Grade Gliomas
A Phase 1 study of Adult Glioblastoma and Adult Giant Cell Glioblastoma, sponsored by City of Hope Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT02015819: Completed Phase 1 study of Adult Glioblastoma and Adult Giant Cell Glioblastoma, sponsored by City of Hope Medical Center.
NCT02015819 is a Phase 1 study of Adult Glioblastoma and Adult Giant Cell Glioblastoma that has completed, run by City of Hope Medical Center. The registered enrollment target is 16 participants, below the 43-participant average among 14 other Adult Glioblastoma trials with a reported enrollment target (63% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02015819, a Phase 1 study of Adult Glioblastoma and Adult Giant Cell Glioblastoma, has completed, sponsored by City of Hope Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial studies the side effects and determines the best dose of genetically modified neural stem cells and flucytosine when given together with leucovorin for treating patients with recurrent high-grade gliomas. Neural stem cells can travel to sites of tumor in the brain. The neural stem cells that are being used in this study were genetically modified express the enzyme cytosine deaminase (CD), which converts the prodrug flucytosine (5-FC) into the chemotherapy agent 5-fluorouracil (5-FU). Leucovorin may help 5-FU kill more tumor cells. The CD-expressing neural stem cells are administered directly into the brain. After giving the neural stem cells a few days to spread out and migrate to tumor cells, research participants take a 7 day course of oral 5-FC. (Depending on when a research participant enters the study, they may also be given leucovorin to take with the 5-FC.) When the 5-FC crosses into brain, the neural stem cells convert it into 5-FU, which diffuses out of the neural stem cells to preferentially kill rapidly dividing tumor cells while minimizing toxicity to healthy tissues. A Rickham catheter, placed at the time of surgery, will be used to administer additional doses of NSCs every two weeks, followed each time by a 7 day course of oral 5-FC (and possibly leucovorin). This neural stem cell-based anti-cancer strategy may be an effective treatment for high-grade gliomas. Funding Source - FDA OOPD
Primary Outcome
Number of DLTs per dose level and the MTD/MFD.
Conditions Studied
Interventions
- OTHER laboratory biomarker analysis
- OTHER pharmacological study
- DRUG leucovorin calcium
- BIOLOGICAL E. coli CD-expressing genetically modified neural stem cells
- DRUG flucytosine
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2014-10-07 |
| Est. Completion | 2017-10-07 |
| Phase | Phase 1 |
What the finished NCT02015819 record still lists
NCT02015819 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 43-participant average among 14 other Adult Glioblastoma trials with a reported enrollment target (63% lower).
The record links to 7 conditions, with Adult Glioblastoma appearing as the primary indexed condition, and to 5 interventions - of which laboratory biomarker analysis is the first listed.
NCT02015819 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT02015819 about?
NCT02015819 is a clinical study titled "Genetically Modified Neural Stem Cells, Flucytosine, and Leucovorin for Treating Patients With Recurrent High-Grade Gliomas". This phase I trial studies the side effects and determines the best dose of genetically modified neural stem cells and flucytosine when given together with leucovorin for treating patients with recurrent high-grade gliomas. Neural stem cells can travel to sites of tumor in the brain. The neural stem...
What is the current status of trial NCT02015819?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2014-10-07. Estimated completion is 2017-10-07.
What conditions does trial NCT02015819 study?
This clinical trial studies the following conditions: Adult Glioblastoma, Adult Giant Cell Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Tumor, Adult Anaplastic Astrocytoma.
What interventions are being tested in trial NCT02015819?
The interventions under investigation include: laboratory biomarker analysis (OTHER), pharmacological study (OTHER), leucovorin calcium (DRUG), E. coli CD-expressing genetically modified neural stem cells (BIOLOGICAL), flucytosine (DRUG).
Who is sponsoring clinical trial NCT02015819?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02015819 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
Similar trials for Adult Glioblastoma
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 NCT02015819's enrollment target sits among peer trials
16 12th of 14 higher than 3 of 14 other Adult Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Adult 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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