Rapid infusion of dinutuximab with chemotherapy for Neuroblastoma

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Childrens Hospital Los Angeles, Los Angeles, CA
Neuroblastoma
Dinutuximab with Chemotherapy - Drug
Eligibility
Any Age
All Sexes
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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 we 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.

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Other trials for Neuroblastoma

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: Day 22 of study therapy until Day 126

Day 21
Determine average dinutuximab infusion time in Cycle 1
Determine feasibility of administering dinutuximab in Cycle 1
Day 126
Determine average dinutuximab infusion time in Cycles 2-6
Determine feasibility of administering Dinutuximab in Cycle 2-6 in 4 hrs or less

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Neuroblastoma

Trial Design

1 Treatment Group

Rapid infusion of dinutuximab with chemotherapy
1 of 1
Experimental Treatment

11 Total Participants · 1 Treatment Group

Primary Treatment: Rapid infusion of dinutuximab with chemotherapy · No Placebo Group · Phase 4

Rapid infusion of dinutuximab with chemotherapy
Drug
Experimental Group · 1 Intervention: Dinutuximab with Chemotherapy · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 22 of study therapy until day 126

Trial Background

Araz Marachelian, Attending Physician
Principal Investigator
Children's Hospital Los Angeles
Closest Location: Childrens Hospital Los Angeles · Los Angeles, CA
Photo of childrens hospital los angeles  1Photo of childrens hospital los angeles  2Photo of childrens hospital los angeles  3
2004First Recorded Clinical Trial
15 TrialsResearching Neuroblastoma
85 CompletedClinical Trials

Eligibility Criteria

Age Any Age · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a diagnosis of relapsed, refractory, or persistent high-risk neuroblastoma or ganglioneuroblastoma.
Patients must be 12 months of age or older at the time of enrollment.
You are at least 14 days post-transplantation.
You have received previous treatment with dinutuximab.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References