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Monoclonal Antibodies
Rapid Infusion of Dinutuximab for Neuroblastoma (RAPID Trial)
Phase 4
Recruiting
Led By Sara-Jane Onyeama, MD
Research Sponsored by Children's Hospital Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have adequate bone marrow function
Patients must have a diagnosis of relapsed, refractory, or persistent high-risk neuroblastoma or ganglioneuroblastoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 22 of study therapy until day 126
Awards & highlights
RAPID Trial Summary
This trial is testing whether the anti-GD2 human-mouse chimeric monoclonal antibody dinutuximab can be given to children with high-risk neuroblastoma over four hours or less, which would allow for administration of this immunotherapy agent in the outpatient setting.
Who is the study for?
This trial is for children with high-risk neuroblastoma who have previously been treated with dinutuximab, either alone or with chemotherapy. They must not be breastfeeding or pregnant and agree to use contraception if of childbearing potential. Participants need normal organ function, no severe allergies to anti-GD2 antibodies, and cannot be on certain medications that affect the immune system.Check my eligibility
What is being tested?
The study tests a rapid infusion method of dinutuximab over four hours or less in children with high-risk neuroblastoma. The goal is to see if this faster delivery can reduce hospital stays and costs while maintaining safety and effectiveness compared to the standard longer infusion times.See study design
What are the potential side effects?
Possible side effects include allergic reactions to the antibody treatment, which could range from mild skin reactions to more serious issues affecting breathing or blood pressure. Other common side effects might involve fever, pain at the injection site, vomiting, diarrhea, low blood pressure, rash, and difficulty breathing.
RAPID Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My bone marrow is functioning well.
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My diagnosis is high-risk neuroblastoma or ganglioneuroblastoma that has come back or not responded to treatment.
Select...
I am at least 1 year old.
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I completed at least 4 rounds of strong chemotherapy for my cancer.
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I have been treated with dinutuximab before.
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My liver is working well.
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My kidneys are working well.
RAPID Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 22 of study therapy until day 126
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 22 of study therapy until day 126
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine average dinutuximab infusion time in Cycle 1
Determine feasibility of administering dinutuximab in Cycle 1
Secondary outcome measures
Determine average dinutuximab infusion time in Cycles 2-6
Determine feasibility of administering Dinutuximab in Cycle 2-6 in 4 hrs or less
RAPID Trial Design
1Treatment groups
Experimental Treatment
Group I: Rapid infusion of dinutuximab with chemotherapyExperimental Treatment1 Intervention
Patients will receive chemotherapy and dinutuximab via rapid infusion
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Who is running the clinical trial?
Children's Hospital Los AngelesLead Sponsor
232 Previous Clinical Trials
5,076,513 Total Patients Enrolled
10 Trials studying Neuroblastoma
865 Patients Enrolled for Neuroblastoma
United TherapeuticsIndustry Sponsor
108 Previous Clinical Trials
14,376 Total Patients Enrolled
6 Trials studying Neuroblastoma
173 Patients Enrolled for Neuroblastoma
Sara-Jane Onyeama, MDPrincipal InvestigatorChildren's Hospital Los Angeles
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My heart is functioning well.I do not have any major illness that would make it hard for me to handle the treatment.My brain functions are normal.My partner and I agree to use birth control.I cannot tolerate a full dose of dinutuximab in 20 hours or less.My bone marrow is functioning well.My diagnosis is high-risk neuroblastoma or ganglioneuroblastoma that has come back or not responded to treatment.I am of childbearing age and my pregnancy test is negative.I am at least 1 year old.I completed at least 4 rounds of strong chemotherapy for my cancer.My lungs work well enough for treatment.I don't need oxygen support and can breathe well at rest.I have not been diagnosed with myelodysplastic syndrome or any cancer other than neuroblastoma.I have been treated with dinutuximab before.I have never had a severe allergic reaction to anti-GD2 antibodies.I do not have any infections that aren't responding to treatment.My liver is working well.I haven't taken seizure medication that affects enzymes in the last week.I am willing to stop breastfeeding if I join the trial.My kidneys are working well.My cancer does not need to be in multiple places to join this study.
Research Study Groups:
This trial has the following groups:- Group 1: Rapid infusion of dinutuximab with chemotherapy
Awards:
This trial has 5 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Neuroblastoma Patient Testimony for trial: Trial Name: NCT05421897 — Phase 4
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies remaining in this investigation for potential participants?
"Not at this time. Clinicaltrials.gov informs us that the initial post was made on July 1, 2022 and modified most recently in June of 13th 2022; thus, it is no longer seeking participants for this trial. However, there are 161 other clinical trials actively recruiting patients across various sites currently available to join."
Answered by AI
What has been observed in regards to Dinutuximab's compatibility with Chemotherapy?
"Dinutuximab combined with chemotherapy is deemed a safe treatment by our team, scoring it at 3 on the safety scale. This high rating indicates that this intervention has already been approved and regulated."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
Read about the positive. results of dinutuximab for Neuroblastoma hence need to enroll for this trial as I can not afford expense for my daughters Neuroblastoma treatment for this drug.
PatientReceived no prior treatments
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