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NCT04958486 · ClinicalTrials.gov registry record · Early Phase 1
Combination Intraventricular Chemotherapy Pilot Study: 5-Azacytidine (5-AZA) and Trastuzumab Infusions Into the Fourth Ventricle or Resection Cavity in Children and Adults with Recurrent or Residual 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
- 4
- Enrollment target
NCT04958486: Completed Early Phase 1 study, sponsored by The University of Texas Health Science Center, Houston.
NCT04958486 is a Early Phase 1 study that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 4 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04958486, 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
- 4 participants
- Enrollment target
Study Summary
The purpose of this study is to establish the safety and tolerability of simultaneous infusions of 5-Azacytidine and trastuzumab into the fourth ventricle of the brain or resection cavity in patients with recurrent posterior fossa ependymoma and to assess the antitumor activity of simultaneous infusions of 5-Azacytidine and trastuzumab into the fourth ventricle of the brain or resection cavity in patients based upon imaging studies and lumbar cerebrospinal fluid (CSF) cytology.
Primary Outcome
A new neurological deficit will be defined as new cranial neuropathy, change in level of consciousness, motor weakness, gait change or cerebellar finding (ataxia, dysmetria, dysdiadochokinesis) that is attributed by treating physicians to infusions. New neurological deficits graded as Grade 3 or higher after infusions will be defined as serious adverse events (SAE's)
Interventions
- DRUG 5-Azacytidine and trastuzumab infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2021-07-08 |
| Est. Completion | 2023-09-29 |
| Phase | Early Phase 1 |
What the finished NCT04958486 record still lists
NCT04958486 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which 5-Azacytidine and trastuzumab infusion is the first listed.
NCT04958486 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04958486 about?
NCT04958486 is a clinical study titled "Combination Intraventricular Chemotherapy Pilot Study: 5-Azacytidine (5-AZA) and Trastuzumab Infusions Into the Fourth Ventricle or Resection Cavity in Children and Adults with Recurrent or Residual Posterior Fossa Ependymoma". The purpose of this study is to establish the safety and tolerability of simultaneous infusions of 5-Azacytidine and trastuzumab into the fourth ventricle of the brain or resection cavity in patients with recurrent posterior fossa ependymoma and to assess the antitumor activity of simultaneous infus...
What is the current status of trial NCT04958486?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 4 participants. The study started on 2021-07-08. Estimated completion is 2023-09-29.
What interventions are being tested in trial NCT04958486?
The interventions under investigation include: 5-Azacytidine and trastuzumab infusion (DRUG).
Who is sponsoring clinical trial NCT04958486?
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 NCT04958486's enrollment target sits among peer trials
4 1922nd of 2000 higher than 53 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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