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NCT02940483 · ClinicalTrials.gov registry record · Early Phase 1
Infusion of 5-Azacytidine (5-AZA) Into the Fourth Ventricle in Children With Recurrent Posterior Fossa Ependymoma
A Early Phase 1 study, sponsored by The University of Texas Health Science Center, Houston.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 6
- Enrollment target
NCT02940483: Completed Early Phase 1 study, sponsored by The University of Texas Health Science Center, Houston.
NCT02940483 is a Early Phase 1 study that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 6 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02940483, a Early Phase 1 study, has completed, sponsored by The University of Texas Health Science Center, Houston.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to establish the safety of direct administration of 5-Azacytidine into the fourth ventricle of the brain or resection cavity in patients with recurrent posterior fossa ependymoma.
Primary Outcome
New neurological deficit defined as new cranial neuropathy, nystagmus, change in mental status, motor deficit or cerebellar finding (ataxia, dysmetria, dysdiadochokinesis) that is attributed by treating physicians to intraventricular 5-Azacytidine infusions. Primary endpoint for basis of safety monitoring is acute toxicity occurring at any time within 30 days of receiving the intraventricular 5-Azacytidine infusion. Rate of acute toxicity monitored using Bayesian method of Thall and Sung. Method
Interventions
- DRUG 5-Azacytidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2017-02-01 |
| Est. Completion | 2018-11-28 |
| Phase | Early Phase 1 |
What the finished NCT02940483 record still lists
NCT02940483 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 1 intervention - of which 5-Azacytidine is the first listed.
NCT02940483 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02940483 about?
NCT02940483 is a clinical study titled "Infusion of 5-Azacytidine (5-AZA) Into the Fourth Ventricle in Children With Recurrent Posterior Fossa Ependymoma". The goal of this clinical research study is to establish the safety of direct administration of 5-Azacytidine into the fourth ventricle of the brain or resection cavity in patients with recurrent posterior fossa ependymoma.
What is the current status of trial NCT02940483?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 6 participants. The study started on 2017-02-01. Estimated completion is 2018-11-28.
What interventions are being tested in trial NCT02940483?
The interventions under investigation include: 5-Azacytidine (DRUG).
Who is sponsoring clinical trial NCT02940483?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02940483's enrollment target sits among peer trials
6 1846th of 2000 higher than 114 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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