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NCT02035137 · ClinicalTrials.gov registry record · Phase 2
131I-MIBG Alone VS. 131I-MIBG With Vincristine and Irinotecan VS131I-MIBG With Vorinostat
A Phase 2 study, sponsored by New Approaches to Neuroblastoma Therapy Consortium.
- Completed
- Registry status
- Phase 2
- Development phase
- 114
- Enrollment target
NCT02035137: Completed Phase 2 study, sponsored by New Approaches to Neuroblastoma Therapy Consortium.
NCT02035137 is a Phase 2 study that has completed, run by New Approaches to Neuroblastoma Therapy Consortium. The registered enrollment target is 114 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02035137, a Phase 2 study, has completed, sponsored by New Approaches to Neuroblastoma Therapy Consortium.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 114 participants
- Enrollment target
Study Summary
This study will compare three treatment regimens containing metaiodobenzylguanidine (MIBG) and compare their effects on tumor response and associated side effects, to determine if one therapy is better than the other for people diagnosed with relapsed or persistent neuroblastoma.
Primary Outcome
To identify the MIBG treatment regimen associated with the highest overall response rate after one course of treatment on the three arms. The response evaluation was based on central review (intent to treat analysis). Responders defined as meeting CR/MRD/PR criteria. Response was based on NANT response criteria v1.2 (https://doi.org/10.1002/pbc.26940). RECST 1.1 criteria was used for measurable tumors with PR criteria \> 30% decrease in target tumor size. Curie score was used with PR criteria \>
Interventions
- DRUG Vincristine
- DRUG Irinotecan
- DRUG Vorinostat
- RADIATION 131I-MIBG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2014-07 |
| Est. Completion | 2021-02-26 |
| Phase | Phase 2 |
What the finished NCT02035137 record still lists
NCT02035137 is an interventional study that assigns participants to a tested intervention. The registered 114 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% lower).
The record links to 0 conditions, and to 4 interventions - of which Vincristine is the first listed.
NCT02035137 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02035137 about?
NCT02035137 is a clinical study titled "131I-MIBG Alone VS. 131I-MIBG With Vincristine and Irinotecan VS131I-MIBG With Vorinostat". This study will compare three treatment regimens containing metaiodobenzylguanidine (MIBG) and compare their effects on tumor response and associated side effects, to determine if one therapy is better than the other for people diagnosed with relapsed or persistent neuroblastoma.
What is the current status of trial NCT02035137?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 114 participants. The study started on 2014-07. Estimated completion is 2021-02-26.
What interventions are being tested in trial NCT02035137?
The interventions under investigation include: Vincristine (DRUG), Irinotecan (DRUG), Vorinostat (DRUG), 131I-MIBG (RADIATION).
Who is sponsoring clinical trial NCT02035137?
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 NCT02035137's enrollment target sits among peer trials
114 627th of 2000 higher than 1,370 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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