Clinical Trials Logo

Clinical Trial Summary

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


Clinical Trial Description

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. - A therapeutic dose (50mCi) of 131I-omburtamab is administered during week 1 (week 2 for Japan) followed by a 3-week observation period that includes a repeated MRI, CSF cytology, and safety monitoring. - A second treatment cycle of 131I-omburtamab is administered during week 5 (week 6 for Japan) if there is no objective disease progression week 5 after the first injection, and the participant is presenting without unexpected and clinical significant Grade 4 toxicity. For participants with ongoing Grade 3 toxicity a second doing cycle will take place according to the discretion of the investigator. 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03275402
Study type Interventional
Source Y-mAbs Therapeutics
Contact
Status Terminated
Phase Phase 2/Phase 3
Start date December 11, 2018
Completion date June 2, 2023

See also
  Status Clinical Trial Phase
Completed NCT00492167 - Beta-Glucan and Monoclonal Antibody 3F8 in Treating Patients With Metastatic Neuroblastoma Phase 1
Completed NCT04474678 - Quality Improvement Project - "My Logbook! - I Know my Way Around!"; ("Mein Logbuch - Ich Kenne Mich Aus!") N/A
Terminated NCT00801931 - Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders Phase 1/Phase 2
Active, not recruiting NCT03107988 - NANT 2015-02: A Phase 1 Study of Lorlatinib (PF-06463922) Phase 1
Recruiting NCT04253015 - A Post-Authorisation Safety Study Patient Registry of Patients With Neuroblastoma Being Treated With Dinutuximab Beta
Terminated NCT00788125 - Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors Phase 1/Phase 2
Completed NCT03273712 - Dosimetry-Guided, Peptide Receptor Radiotherapy (PRRT) With 90Y-DOTA- tyr3-Octreotide (90Y-DOTATOC) Phase 2
Recruiting NCT02933333 - G-CSF Alone or Combination With GM-CSF on Prevention and Treatment of Infection in Children With Malignant Tumor Phase 4
Recruiting NCT00588068 - Molecular Characterization of Neuroblastic Tumor: Correlation With Clinical Outcome
Recruiting NCT04301843 - Eflornithine (DFMO) and Etoposide for Relapsed/Refractory Neuroblastoma Phase 2
Completed NCT00026780 - Eligibility Screening for a NCI Pediatric Oncology Branch Research Study
Recruiting NCT04040088 - An Investigational Scan (68Ga-DOTATATE PET/CT) in Diagnosing Pediatric Metastatic Neuroendocrine Tumors Early Phase 1
Recruiting NCT06057948 - A Study of a Vaccine in Combination With Beta-glucan in People With Neuroblastoma Phase 2
Not yet recruiting NCT06335745 - PediCARE Health Equity Intervention in High-Risk Neuroblastoma N/A
Recruiting NCT02559778 - Pediatric Precision Laboratory Advanced Neuroblastoma Therapy Phase 2
Completed NCT02441062 - Impact of Ga-68 DOTATOC PET-CT Imaging in Management of Neuroendocrine Tumors Phase 2
Active, not recruiting NCT02245997 - Local Control With Reduced-dose Radiotherapy for High-Risk Neuroblastoma N/A
Not yet recruiting NCT01156350 - Haplo-identical Hematopoietic Stem Cell Transplantation Following Reduced-intensity Conditioning in Children With Neuroblastoma Phase 2
Active, not recruiting NCT01192555 - Allogeneic Tumor Cell Vaccination With Oral Metronomic Cytoxan in Patients With High-Risk Neuroblastoma Phase 1/Phase 2
Completed NCT01222780 - To Evaluate the Safety, Activity and Pharmacokinetics of Marqibo in Children and Adolescents With Refractory Cancer Phase 1