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NCT05421897 · ClinicalTrials.gov registry record · Phase 1
Rapid Administration Pilot for Infusing Dinutuximab
A Phase 1 study of Neuroblastoma, sponsored by Children's Hospital Los Angeles.
- Active
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
- 1
- Study location
NCT05421897 is a Phase 1 study of Neuroblastoma that is active but no longer recruiting, run by Children's Hospital Los Angeles. The registered enrollment target is 11 participants, below the 239-participant average among 94 other Neuroblastoma trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05421897, a Phase 1 study of Neuroblastoma, is active but no longer recruiting, sponsored by Children's Hospital Los Angeles.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
- 1
- Study location
Study Summary
Studies have shown that the anti-GD2 human-mouse chimeric monoclonal antibody dinutuximab has contributed significantly to the improvement of treatment for children with high-risk neuroblastoma and has become a mainstay in treating high risk neuroblastoma in children as part of up-front therapy and relapsed/refractory therapy. The administration of dinutuximab requires a significant amount of time and resources to complete the 10-20 hour standard infusion time for 4 days in the inpatient setting. During its early development, a phase I study profiling the clinical efficacy and tolerability of dinutuximab infusions in children successfully infused dinutuximab at various rates including over 1 hour at different dose levels. In the adult setting, dinutuximab has been tolerated over substantially shorter infusion times (less than 2 hours). Additionally, another anti-GD2 murine monoclonal antibody naxitamab, which has a similar toxicity profile to dinutuximab, is FDA approved for administration over 90 minutes and is successfully administered in outpatient setting. Given this reassuring data the investigators aim to evaluate the feasibility of the rapid administration of dinutuximab over four hours or less in our patient population of children with high-risk neuroblastoma. The pharmacokinetics, toxicity profile and supportive care requirements will be analyzed and described in order to determine if rapid infusion of dinutuximab can be successfully tolerated over four hours or less which would allow for administration of this agent in the outpatient setting. Should this trial prove to be successful, it would serve to decrease the hospital burden in a positive way by allowing for administration of this immunotherapy agent in the outpatient setting and patients may prefer shorter infusion duration. Furthermore, it could lessen overall costs and inpatient admissions for patients.
Conditions Studied
Interventions
- DRUG Dinutuximab with Chemotherapy
Study Locations (1)
California
- Childrens Hospital Los Angeles - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2022-11-29 |
| Est. Completion | 2026-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05421897
The ClinicalTrials.gov registry entry for NCT05421897 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 239-participant average among 94 other Neuroblastoma trials with a reported enrollment target (95% lower). The listed sponsor is Children's Hospital Los Angeles, which has 119 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Neuroblastoma appearing as the primary indexed condition, and to 1 intervention - of which Dinutuximab with Chemotherapy is the first listed.
NCT05421897 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT05421897 about?
NCT05421897 is a clinical study titled "Rapid Administration Pilot for Infusing Dinutuximab". Studies have shown that the anti-GD2 human-mouse chimeric monoclonal antibody dinutuximab has contributed significantly to the improvement of treatment for children with high-risk neuroblastoma and has become a mainstay in treating high risk neuroblastoma in children as part of up-front therapy and ...
What is the current status of trial NCT05421897?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2022-11-29. Estimated completion is 2026-01.
What conditions does trial NCT05421897 study?
This clinical trial studies the following conditions: Neuroblastoma.
What interventions are being tested in trial NCT05421897?
The interventions under investigation include: Dinutuximab with Chemotherapy (DRUG).
Who is sponsoring clinical trial NCT05421897?
This trial is sponsored by Children's Hospital Los Angeles, which has 119 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05421897 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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