A Multicenter Phase 2/3 Trial of the Efficacy and Safety of Intracerebroventricular Radioimmunotherapy using 131I-burtomab for Neuroblastoma Central Nervous System/Leptomeningeal Metastases
Investigating Treatment Effects of an Investigational Antibody in Pediatric Neuroblastoma
Brief description of study.
The purpose of this research study is to find out about the treatment effects of an antibody called murine 8H9 (mu8H9).
Detailed description of study
The proposed phase 2/3 international multi-center trial evaluates the efficacy and safety of intracerebroventricular 131I-burtomab as well as the dosimetry in pediatric NB patients with CNS/LM metastases. The findings of the proposed trial will expand and be compared with the findings of the single center trial of intracerebroventricular 131I-burtomab in pediatric patients with NB CNS/LM metastases treated in the MSK Trial 03-133. The aggregate findings from the two trials evaluating patients from several centers in the US as well as Europe seek to provide a basis for establishing 131I-burtomab as the next generation treatment of NB patients with CNS/LM metastases.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Leptomeningeal Metastases,CNS Metastases,Neuroblastoma
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Age: 18 years or below
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Gender: All
Inclusion Criteria
Patients must have a histologically confirmed diagnosis of neuroblastoma with relapse in the central nervous system or in the meninges (leptomeningeal)
Exclusion Criteria
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 first dose of 131I-omburtamab in this trial
Patients must not have received systemic chemotherapy (corticosteroids not included) less than 3 weeks prior to enrollment in this trial
Patients must not have severe major non-hematologic organ toxicity; specifically, any renal, cardiac, hepatic, pulmonary, and gastrointestinal system toxicity must fall below Grade 3 prior to enrollment in this trial. Patients with stable neurological deficits (due to brain tumor) are not excluded. Patients with Grade 3 or lower hearing loss are not excluded.
This study investigates the effects of an investigational antibody treatment for children with a type of cancer called neuroblastoma that has spread to the brain or the lining of the brain and spinal cord. Neuroblastoma is a cancer that starts in young nerve cells and can spread to other parts of the body. The study aims to understand how well the treatment works and how safe it is for these patients.
Participants in this study will receive a treatment called intracerebroventricular 131I-burtomab. This involves delivering the treatment directly into the fluid-filled spaces of the brain, which is known as the ventricular system. The study will monitor the effects of this treatment and compare them with previous research to determine its effectiveness.
- Who can participate: Children diagnosed with neuroblastoma that has returned in the central nervous system or the meninges can participate. They must not have a primary tumor in the central nervous system or any severe organ toxicity.
- Study details: Participants will receive the investigational treatment directly into the brain's ventricular system. This study does not involve a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine.
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