Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03332667 · ClinicalTrials.gov registry record · Phase 1
MIBG With Dinutuximab +/- Vorinostat
A Phase 1 study, sponsored by New Approaches to Neuroblastoma Therapy Consortium.
- Completed
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
NCT03332667: Completed Phase 1 study, sponsored by New Approaches to Neuroblastoma Therapy Consortium.
NCT03332667 is a Phase 1 study that has completed, run by New Approaches to Neuroblastoma Therapy Consortium. The registered enrollment target is 45 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03332667, a Phase 1 study, has completed, sponsored by New Approaches to Neuroblastoma Therapy Consortium.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
Study Summary
131I-Metaiodobenzylguanidine (131I-MIBG) is one of the most effective therapies utilized for neuroblastoma patients with refractory or relapsed disease. In this pediatric phase 1 trial, 131I-MIBG will be given in combination with dinutuximab, a chimeric 14.18 monoclonal antibody. This study will utilize a traditional Phase I rolling 6 dose escalation design to determine a recommended phase 2 pediatric dose. An expansion cohort of an additional 6 patients will then be enrolled. If tolerable, vorinostat will then be added to the third dose level. A 6 patient expansion cohort may then be enrolled.
Primary Outcome
Proportion of patients with Course 1 DLT in Cohort A
Interventions
- DRUG Vorinostat
- DRUG Sargramostim
- DRUG Dinutuximab
- RADIATION 131I-MIBG
- DRUG Potassium Iodide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2018-09-12 |
| Est. Completion | 2024-02-23 |
| Phase | Phase 1 |
What the finished NCT03332667 record still lists
NCT03332667 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 5 interventions - of which Vorinostat is the first listed.
NCT03332667 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03332667 about?
NCT03332667 is a clinical study titled "MIBG With Dinutuximab +/- Vorinostat". 131I-Metaiodobenzylguanidine (131I-MIBG) is one of the most effective therapies utilized for neuroblastoma patients with refractory or relapsed disease. In this pediatric phase 1 trial, 131I-MIBG will be given in combination with dinutuximab, a chimeric 14.18 monoclonal antibody. This study will uti...
What is the current status of trial NCT03332667?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2018-09-12. Estimated completion is 2024-02-23.
What interventions are being tested in trial NCT03332667?
The interventions under investigation include: Vorinostat (DRUG), Sargramostim (DRUG), Dinutuximab (DRUG), 131I-MIBG (RADIATION), Potassium Iodide (DRUG).
Who is sponsoring clinical trial NCT03332667?
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 NCT03332667's enrollment target sits among peer trials
45 1066th of 2000 higher than 915 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00804154 · 45 participants · Phase 1
Resiniferatoxin to Treat Severe Pain Associated With Advanced Cancer
- NCT01851694 · 45 participants · NA
Beta-cell Response to Incretin Hormones in Cystic Fibrosis
- NCT02896335 · 45 participants · Phase 2
Palbociclib and Pembrolizumab In Central Nervous System Metastases
- NCT03454035 · 45 participants · Phase 1
Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI