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NCT03050450 · ClinicalTrials.gov registry record · Phase 1
Study of Lenalidomide With Vorinostat in Pediatric Patients With High Grade or Progressive CNS Tumors
A Phase 1 study, sponsored by Johns Hopkins All Children's Hospital.
- Terminated
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT03050450: Clinical Trial Phase 1 study, sponsored by Johns Hopkins All Children's Hospital.
NCT03050450 is a Phase 1 study that was terminated before completion, run by Johns Hopkins All Children's Hospital. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03050450, a Phase 1 study, was terminated before completion, sponsored by Johns Hopkins All Children's Hospital.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
Independently, both lenalidomide and vorinostat have shown promising activity in pediatric central nervous system (CNS) tumors. These are both agents that are not typically part of first-line studies, although both agents are of serious interest and are currently in clinical trials for further investigation. This study is to evaluate the combination of lenalidomide and vorinostat in high grade or progressive central nervous system tumors in children.
Primary Outcome
Collect and grade all of the adverse events to evaluate for safety. This data was collected for the first 2 cycles for each participant.
Interventions
- DRUG 25 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)
- DRUG 50 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)
- DRUG 100 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)
- DRUG 150 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)
- DRUG 150 mg/m2 Lenalidomide (Revlimid®) and 230 mg/m2 Vorinostat (Zolinza®)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2016-08-10 |
| Est. Completion | 2018-12-19 |
| Phase | Phase 1 |
Why NCT03050450 stopped before completion
NCT03050450 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 5 interventions - of which 25 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®) is the first listed.
NCT03050450 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03050450 about?
NCT03050450 is a clinical study titled "Study of Lenalidomide With Vorinostat in Pediatric Patients With High Grade or Progressive CNS Tumors". Independently, both lenalidomide and vorinostat have shown promising activity in pediatric central nervous system (CNS) tumors. These are both agents that are not typically part of first-line studies, although both agents are of serious interest and are currently in clinical trials for further inves...
What is the current status of trial NCT03050450?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2016-08-10. Estimated completion is 2018-12-19.
What interventions are being tested in trial NCT03050450?
The interventions under investigation include: 25 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®) (DRUG), 50 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®) (DRUG), 100 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®) (DRUG), 150 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®) (DRUG), 150 mg/m2 Lenalidomide (Revlimid®) and 230 mg/m2 Vorinostat (Zolinza®) (DRUG).
Who is sponsoring clinical trial NCT03050450?
This trial is sponsored by Johns Hopkins All Children's Hospital, which has 24 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03050450's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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