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NCT01019850 · ClinicalTrials.gov registry record · Phase 1
N2007-03: Vorinostat and 131-I MIBG in Treating Patients With Resistant or Relapsed Neuroblastoma
A Phase 1 study, sponsored by New Approaches to Neuroblastoma Therapy Consortium.
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT01019850: Completed Phase 1 study, sponsored by New Approaches to Neuroblastoma Therapy Consortium.
NCT01019850 is a Phase 1 study that has completed, run by New Approaches to Neuroblastoma Therapy Consortium. The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01019850, a Phase 1 study, has completed, sponsored by New Approaches to Neuroblastoma Therapy Consortium.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study Summary
RATIONALE: Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radioactive drugs, such as iobenguane I 131, may carry radiation directly to tumor cells and not harm normal cells. Giving vorinostat together with iobenguane I 131 may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of giving vorinostat together with iobenguane I 131 in treating patients with resistant or relapsed neuroblastoma.
Primary Outcome
All toxicities observed will be summarized in terms of type (organ affected or laboratory determination), severity (by NCI CTCAE) and attribution. Tables will be created to summarize these toxicities and side effects by dose level and by course.
Interventions
- DRUG Vorinostat
- DRUG Filgrastim
- RADIATION 131- I Metaiodobenzylguanidine
- PROCEDURE Peripheral Blood Stem Cell Infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2010-03 |
| Est. Completion | 2015-02 |
| Phase | Phase 1 |
What the finished NCT01019850 record still lists
NCT01019850 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 4 interventions - of which Vorinostat is the first listed.
NCT01019850 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01019850 about?
NCT01019850 is a clinical study titled "N2007-03: Vorinostat and 131-I MIBG in Treating Patients With Resistant or Relapsed Neuroblastoma". RATIONALE: Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radioactive drugs, such as iobenguane I 131, may carry radiation directly to tumor cells and not harm normal cells. Giving vorinostat together with iobenguane I 131 may kill more tumor ce...
What is the current status of trial NCT01019850?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2010-03. Estimated completion is 2015-02.
What interventions are being tested in trial NCT01019850?
The interventions under investigation include: Vorinostat (DRUG), Filgrastim (DRUG), 131- I Metaiodobenzylguanidine (RADIATION), Peripheral Blood Stem Cell Infusion (PROCEDURE).
Who is sponsoring clinical trial NCT01019850?
This trial is sponsored by New Approaches to Neuroblastoma Therapy Consortium, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01019850's enrollment target sits among peer trials
27 1463rd of 2000 higher than 519 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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