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Monoclonal Antibodies
131I-omburtamab for Neuroblastoma
Phase 2 & 3
Waitlist Available
Research Sponsored by Y-mAbs Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have a histologically confirmed diagnosis of neuroblastoma with relapse in the central nervous system or in the meninges (leptomeningeal).
Patients must be between the ages of birth and 18 years at the time of screening.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial will test a new treatment for children with neuroblastoma that has spread to the brain or spinal cord. Up to 2 rounds of treatment will be given, and researchers will track how well the treatment works and how safe it is.
Who is the study for?
This trial is for children up to 18 years old with neuroblastoma that has spread to the brain or meninges. They should have a life expectancy of at least 3 months and not have primary CNS neuroblastoma, uncontrolled infections, recent radiation therapy or chemotherapy, or severe organ damage.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of a radioactive antibody treatment called 131I-omburtamab in kids with neuroblastoma metastases in the CNS/leptomeninges. Participants may receive up to two rounds of this intracerebroventricular therapy.See study design
What are the potential side effects?
Potential side effects include reactions related to radioimmunotherapy such as nausea, hair loss at injection site, headache, fatigue, and increased risk of infection due to lowered blood cell counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My neuroblastoma has returned in my brain or spinal cord coverings.
Select...
I am 18 years old or younger.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival Rate
Secondary outcome measures
Assessment of elimination half-life of 131I-omburtamab
Assessment of peak plasma concentration (Cmax) of 131I-omburtamab
Assessment of residence time of 131I-omburtamab
+6 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: 131I-omburtamabExperimental Treatment1 Intervention
One treatment cycle of 131I-omburtamab consists of one dosimetry dose (2 mCi ) (for subjects enrolled on Version 1-7 of Protocol 101) and one treatment dose (50 mCi) for up to 2 cycles of length 5 weeks (for subjects enrolled on Version 1-7 of Protocol 101) or 4 weeks (for subject enrolled after Version 7 of Protocol 101). For Japan only, the first cycle consisted of one dosimetry dose (2 mCi ) week 1 one treatment dose (50 mCi) week 2. If eligible a second cycle of 50 mCi 131I-omburtamab was given at week 6. For subjects below 3 and 1 years of age, the treatment dose was reduced by 33% and 50%, respectively.
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Who is running the clinical trial?
Y-mAbs TherapeuticsLead Sponsor
25 Previous Clinical Trials
1,505 Total Patients Enrolled
12 Trials studying Neuroblastoma
1,140 Patients Enrolled for Neuroblastoma
John Roemer, MDStudy DirectorY-mAbs Therapeutics
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any severe infections that are not under control.I have not had brain or spine radiation in the last 3 weeks.I am 18 years old or younger.My cancer is a neuroblastoma that started in my brain or spinal cord.I haven't had chemotherapy (except for corticosteroids) in the last 3 weeks.I do not have severe issues with my kidneys, heart, liver, lungs, or stomach.My neuroblastoma has returned in my brain or spinal cord coverings.
Research Study Groups:
This trial has the following groups:- Group 1: 131I-omburtamab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there other examples in the medical literature of 131I-omburtamab's efficacy?
"Right now, there are 3 active clinical trials for 131I-omburtamab with 1 in Phase 3. The large majority of these studies are taking place in Columbus, Ohio; however, there are a total of 13 sites running trials for 131I-omburtamab."
Answered by AI
Have there been other similar trials in the past?
"131I-omburtamab has been under investigation since 2018. Y-mAbs Therapeutics sponsored the first research project that year, which only involved 50 people. The drug received Phase 2 & 3 approval after the initial study's success. There are now 3 active studies being conducted in 8 cities and 7 countries simultaneously."
Answered by AI
Are participants still being recruited for this research project?
"The study, which is currently looking for participants, was first posted on December 11th 2018. The most recent update to the trial was made on December 17th 2021."
Answered by AI
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