Rapid Administration Pilot for Infusing Dinutuximab
Public ClinicalTrials.gov record NCT05421897. 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
RAPID Study: A Pilot Study for the Rapid Infusion of Dinutuximab
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Dinutuximab is an immunotherapy that has greatly improved outcomes for children with high-risk neuroblastoma and is now a standard part of treatment for both newly diagnosed and relapsed disease. However, the medication is typically given through an intravenous (IV) infusion over 10-20 hours a day for four consecutive days, requiring prolonged hospital stays that place a significant burden on children, families, and healthcare resources. Earlier studies of dinutuximab, as well as experience with a similar immunotherapy, suggest that these medications can be safely given over a much shorter period of time. This study is evaluating whether children with high-risk neuroblastoma can safely receive dinutuximab over five hours or less. Early results have been encouraging. The first group of patients successfully received most treatments with dinutuximab in about two hours. Children experienced very low pain levels and required approximately 78% less opioid pain medication compared with the traditional longer infusion. Several patients were able to receive treatment as outpatients without requiring hospital admission, while hospitalizations that did occur were primarily related to chemotherapy or other non-medical reasons rather than the rapid infusion itself. The study is now expanded to further evaluate the safety of rapid infusion across multiple treatment cycles at different centers in the United States. Researchers will also examine how the drug is processed by the body, whether the immune system develops antibodies against the treatment, and whether the faster infusion continues to reduce the need for opioid pain medication. In addition, children and their caregivers will complete questionnaires about symptoms and treatment experiences to better understand the impact of the faster dinutuximab infusion on quality of life and the overall treatment experience.
Study identification
- NCT ID
- NCT05421897
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 30 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 1 Year and older
- 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
- Nov 29, 2022 (Actual)
- Primary completion
- Nov 2028 (Estimated)
- Completion
- Nov 2029 (Estimated)
- Last update posted
- Sep 17, 2026
2022 – 2029
United States locations
- U.S. sites
- 7
- U.S. states
- 6
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Childrens Hospital Los Angeles | Los Angeles | California | 90027 | — |
| Childrens Hospital of Colorado | Aurora | Colorado | 80045 | — |
| Children's Hospital of Atlanta | Atlanta | Georgia | 30322 | — |
| C.S. Mott Children's Hospital | Ann Arbor | Michigan | 48109 | — |
| University of Texas Southwestern | Dallas | Texas | 75390 | — |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | — |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | — |
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 NCT05421897, 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 Sep 17, 2026 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05421897 live on ClinicalTrials.gov.