Rapid Administration Pilot for Infusing Dinutuximab
Status:
Not yet recruiting
Trial end date:
2024-08-01
Target enrollment:
Participant gender:
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.