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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
Must not have
Patients with a significant intercurrent illness or disease of any major organ system that would impair their ability to withstand protocol therapy are not eligible
Patients who could not tolerate standard dose of dinutuximab infusion in 20 hours or less are not eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 22 of study therapy until day 126
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Approved for 20 Other Conditions
Pivotal Trial
Drug Has Already Been Approved
Summary
This trial aims to test if a cancer-fighting antibody can be given more quickly to children with high-risk neuroblastoma. The goal is to see if faster treatment is safe and effective, which could make it easier and less costly by allowing it to be done outside the hospital.
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.
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.
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.
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.
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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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any major illness that would make it hard for me to handle the treatment.
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I cannot tolerate a full dose of dinutuximab in 20 hours or less.
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I am of childbearing age and my pregnancy test is negative.
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I have not been diagnosed with myelodysplastic syndrome or any cancer other than neuroblastoma.
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I have never had a severe allergic reaction to anti-GD2 antibodies.
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I do not have any infections that aren't responding to treatment.
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I am willing to stop breastfeeding if I join the 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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Determine average dinutuximab infusion time in Cycle 1
Determine feasibility of administering dinutuximab in Cycle 1
Secondary study objectives
Determine average dinutuximab infusion time in Cycles 2-6
Determine feasibility of administering Dinutuximab in Cycle 2-6 in 4 hrs or less
Awards & Highlights
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.
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Neuroblastoma treatments often include immunotherapy and targeted therapy, which are crucial for improving patient outcomes. Dinutuximab, an anti-GD2 monoclonal antibody, targets the GD2 antigen on neuroblastoma cells, marking them for destruction by the immune system.
This mechanism is significant because it enhances the body's natural ability to fight cancer cells, leading to better survival rates. Other treatments, such as chemotherapy, work by killing rapidly dividing cells, but they can also harm healthy cells.
Immunotherapy like Dinutuximab offers a more targeted approach, reducing collateral damage and improving the quality of life for patients.
PD-1/PD-L1 immune checkpoint inhibitors in glioblastoma: clinical studies, challenges and potential.
PD-1/PD-L1 immune checkpoint inhibitors in glioblastoma: clinical studies, challenges and potential.
Find a Location
Who is running the clinical trial?
Children's Hospital Los AngelesLead Sponsor
246 Previous Clinical Trials
5,073,331 Total Patients Enrolled
10 Trials studying Neuroblastoma
1,365 Patients Enrolled for Neuroblastoma
United TherapeuticsIndustry Sponsor
110 Previous Clinical Trials
14,515 Total Patients Enrolled
7 Trials studying Neuroblastoma
235 Patients Enrolled for Neuroblastoma
Sara-Jane Onyeama, MDPrincipal InvestigatorChildren's Hospital Los Angeles
Media Library
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
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