131I-burtomab Radioimmunotherapy for Neuroblastoma Central Nervous System/Leptomeningeal Metastases
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-burtomab to evaluate efficacy and safety
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
|Eligible Ages||N/A - 18 Years|
- - 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.
- - Patients must have a life expectancy of at least 3 months.
- - Patients with primary neuroblastoma in central nervous system.
- - Patients must not have an uncontrolled life-threatening infection.
- - Patients must not have received cranial or spinal irradiation less than 3 weeks prior to enrolment in this trial.
- - Patients must not have received systemic chemotherapy (corticosteroids not included) less than 3 weeks prior to enrolment in this trial.
- - Patients must not have severe major non-hematologic organ toxicity; specifically, any renal, cardiac,, pulmonary, and gastrointestinal system toxicity must fall below Grade 3.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 0: Exploratory study involving very limited human exposure to the drug to determine whether a drug is modulating its target.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
|Phase 2/Phase 3|
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Neuroblastoma, CNS Metastases, Leptomeningeal Metastases|
One 131I-burtomab treatment cycle takes 5 weeks and includes a dosimetry dose, a treatment dose, an observation period and post-treatment evaluations.
- - A dosimetry dose (2mCi) of 131I-burtomab 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-burtomab is administered during week 2 followed by a 3-week observation period that includes a repeated MRI, CSF cytology, and safety monitoring.
- - A second therapeutic dose (50mCi) of 131I-burtomab is administered during week 6 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.
This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:
For additional contact information, you can also visit the trial on clinicaltrials.gov.