A Phase 2/3 interventional study of 131I-omburtamab in Neuroblastoma, CNS Metastases and Leptomeningeal Metastases, sponsored by Y-mAbs Therapeutics. Terminated at 8 sites in 4 countries. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2024-02-13.
Sponsored by Y-mAbs Therapeutics · Phase 2/3, Interventional, and Treatment
Children with a neuroblastoma diagnose and central nervous system (CNS)/leptomeningeal metastases will be given up to 2 rounds of intracerebroventricular treatment with a radiolabelled monoclonal antibody, 131I-omburtamab to evaluate efficacy and safety
One 131I-omburtamab treatment cycle takes 4 weeks and includes a treatment dose, and an observation period and post-treatment evaluations.
One 131I-omburtamab treatment cycle for Japan only takes 5 weeks and includes a dosimetry dose (2mCi) of 131I-omburtamab is administered during week 1 followed by blood/cerebral spinal fluid (CSF) samples and whole-body scintigraphy at predefined intervals during the following 48 hours after treatment.
Participants can be treated in an outpatient setting or may be admitted as inpatients for both the dosimetry and the therapeutic injections.
Participants completing at least one treatment period will first enter a follow-up period through week 26 and thereafter the long-term follow-up where patients will be evaluated for up to 3 years post-131I-omburtamab treatment where after the trial is ended
Participants will be monitored for adverse events during and after 131I-omburtamab injection and will have pre- and post-treatment clinical assessments including neurologic examination, hematology and serum chemistry, blood and CSF cultures, endocrinology assessments, CSF analysis, and, pre- and post 131I-omburtamab performance testing. Performance testing will be performed at trial baseline, at week 26 and every 6 months during trial period.
In case the patient has a subsequent relapse in the CNS/LM after 131I-omburtamab therapy during the follow-up period, re-treatment to target minimal residual disease can be considered and allowed.
675 studies on the registry are indexed under Neuroblastoma; 127 are open to participants now.
This study's enrollment of 52 is above the median of 32 across 507 interventional studies indexed under Neuroblastoma.
Browse Neuroblastoma studies →Y-mAbs Therapeutics is the lead sponsor of 15 studies on the registry; none are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Biological: 131I-omburtamab
Murine IgG1 monoclonal antibody radiolabeled with iodine-131
Also known as: 131I-8H9
Overall Survival Rate
Overall survival rate at 3 years after the first treatment dose of 131I-omburtamab estimated by the Kaplan-Meier method.
Time frame: 3 years
| Milestone | 131I-omburtamab |
|---|---|
| Started | 52 |
| Completed | 13 |
| Not completed | 39 |
| Withdrew: Death | 17 |
| Withdrew: Study terminated by sponsor | 21 |
| Withdrew: Withdrawal by subject | 1 |
Overall survival rate at 3 years after the first treatment dose of 131I-omburtamab estimated by the Kaplan-Meier method.
| Proportion of participants | 131I-omburtamab |
|---|---|
| Overall Survival Rate | 0.65 (0.49 to 0.78) |
Collected over Adverse events, including serious, were reported from 1st dose until 3 weeks after the last IMP administration. From 3 weeks after the last IMP administration up to 3 years only SAEs considered related to IMP and new onset for cancers were assessed All cause mortality was assessed up to 3 years.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 131I-omburtamab | 17/52 (32.7%) | 20/52 (38.5%) | 49/52 (94.2%) |
| Event | 131I-omburtamab |
|---|---|
| Platelet count decreasedInvestigations | 8/52 |
| Lymphocyte count decreasedInvestigations | 4/52 |
| Haemorrhage intracranialNervous system disorders | 4/52 |
| AnaemiaBlood and lymphatic system disorders | 1/52 |
| Febrile neutropeniaBlood and lymphatic system disorders | 1/52 |
| HypersensitivityImmune system disorders | 1/52 |
| Device related infectionInfections and infestations | 1/52 |
| SepsisInfections and infestations | 1/52 |
| Meningitis chemicalInjury, poisoning and procedural complications | 1/52 |
| Alanine aminotransferase increasedInvestigations | 1/52 |
| Event | 131I-omburtamab |
|---|---|
| White blood cell count decreasedInvestigations | 23/52 |
| Neutrophil count decreasedInvestigations | 22/52 |
| Platelet count decreasedInvestigations | 22/52 |
| NauseaGastrointestinal disorders | 19/52 |
| VomitingGastrointestinal disorders | 18/52 |
| Lymphocyte count decreasedInvestigations | 16/52 |
| AnaemiaBlood and lymphatic system disorders | 15/52 |
| HeadacheNervous system disorders | 12/52 |
| PyrexiaGeneral disorders | 8/52 |
| CoughRespiratory, thoracic and mediastinal disorders | 7/52 |
| Age, Categorical(Participants) | 131I-omburtamab |
|---|---|
| <=18 years | 52 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Age, Continuous(years) | 131I-omburtamab |
|---|---|
| Mean | 4.7 ± 2.45 |
| Sex: Female, Male(Participants) | 131I-omburtamab |
|---|---|
| Female | 22 |
| Male | 30 |
| Ethnicity (NIH/OMB)(Participants) | 131I-omburtamab |
|---|---|
| Hispanic or Latino | 5 |
| Not Hispanic or Latino | 38 |
| Unknown or Not Reported | 9 |
| Race (NIH/OMB)(Participants) | 131I-omburtamab |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 9 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 38 |
| More than one race | 0 |
| Unknown or Not Reported | 3 |
| Region of Enrollment(participants) | 131I-omburtamab |
|---|---|
| United States | 36 |
| Japan | 3 |
| Denmark | 1 |
| Spain | 12 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: Omburtamab I-131
Y-mAbs Therapeutics