MIBG With Dinutuximab +/- Vorinostat
Public ClinicalTrials.gov record NCT03332667. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase I Study of 131I-MIBG With Dinutuximab +/- Vorinostat for Relapsed/Refractory Neuroblastoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03332667
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 45 participants
Conditions and interventions
Conditions
Interventions
- 131I-MIBG Radiation
- Dinutuximab Drug
- Vorinostat Drug
- Sargramostim Drug
- Potassium Iodide Drug
Radiation · Drug
Eligibility (public fields only)
- Age range
- 1 Year to 30 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 11, 2018
- Primary completion
- Feb 22, 2024
- Completion
- Feb 22, 2024
- Last update posted
- Apr 15, 2025
2018 – 2024
United States locations
- U.S. sites
- 12
- U.S. states
- 11
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027-0700 | — |
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94143 | — |
| Children Hospital of Colorado | Aurora | Colorado | 80045 | — |
| AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus | Atlanta | Georgia | 30322 | — |
| University of Chicago, Comer Children's Hospital | Chicago | Illinois | 60637 | — |
| Children's Hospital Boston | Boston | Massachusetts | 02115 | — |
| C.S Mott Children's Hospital | Ann Arbor | Michigan | 48109 | — |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229-3039 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104-4318 | — |
| Cook Children's Healthcare System | Fort Worth | Texas | 76104 | — |
| Children's Hospital and Regional Medical Center - Seattle | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03332667, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 15, 2025 · Synced Sep 3, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03332667 live on ClinicalTrials.gov.