131I-burtomab Radioimmunotherapy for Neuroblastoma Central Nervous System/Leptomeningeal Metastases
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|ClinicalTrials.gov Identifier: NCT03275402|
Recruitment Status : Not yet recruiting
First Posted : September 7, 2017
Last Update Posted : June 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Neuroblastoma CNS Metastases Leptomeningeal Metastases||Biological: 131I-burtomab||Phase 2 Phase 3|
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 treatment cycle 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. 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-burtomab treatment where after the trial is ended
Participants will be monitored for adverse events during and after 131I-burtomab 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-burtomab performance testing. Performance testing will be performed at trial baseline, at week 26 and every 6 months during trial period.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Patients will receive up to two cycles of intracerebroventricular 131I-burtomab. Safety and efficacy will be investigated with short-term follow-up at 26 weeks after treatment and with long-term follow-up for up to 3 years following treatment.|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Phase 2/3 Trial of the Efficacy and Safety of Intracerebroventricular Radioimmunotherapy Using 131I-burtomab for Neuroblastoma Central Nervous System/Leptomeningeal Metastases|
|Estimated Study Start Date :||July 2018|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2022|
One treatment cycle of 131I-burtomab consists of 2 doses; 2mCi at week 1 and 50mCi at week 2). First cycle is initiated right after confirmation of eligibility at week 1. At week 6 the participant will be evaluated for safety and if eligible, receive a second cycle of 131I-burtomab.
Secondary efficacy endpoints will be evaluated at week 26 and primary efficacy endpoint will be evaluated at week 156.
Murine IgG1 monoclonal antibody radiolabeled with iodine-131
Other Name: 131I-8H9
- Overall survival [ Time Frame: 3 years ]Overall survival at 3 years
- Objective response rate [ Time Frame: 3 years ]To evaluate the objective response rate
- CNS progression free survival [ Time Frame: 6 month ]To evaluate the CNS progression free survival
- Dosimetry of 131I-burtomab [ Time Frame: 2 weeks ]To evaluate the dosimetry of 131I-burtomab
- Safety data will be collected via adverse event (AE) and serious adverse event (SAE) reporting during the trial and graded according to CTCAE, version 4.0 [ Time Frame: 3 years ]Safety data will be collected via adverse event (AE) and serious adverse event (SAE) reporting during the trial and graded according to CTCAE, version 4.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03275402
|Contact: Joris Wilmsfirstname.lastname@example.org|
|United States, California|
|Childrens Hospital Los Angeles||Not yet recruiting|
|Los Angeles, California, United States, 90027|
|United States, Florida|
|University of Florida||Not yet recruiting|
|Gainesville, Florida, United States, 32611|
|United States, Indiana|
|Riley Hospital for Children||Not yet recruiting|
|Indianapolis, Indiana, United States, 46202|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Not yet recruiting|
|New York, New York, United States, 10065|
|United States, Ohio|
|Nationwide Children's Hospital||Not yet recruiting|
|Columbus, Ohio, United States, 43205|
|United States, Texas|
|M.D. Anderson Cancer Center||Not yet recruiting|
|Houston, Texas, United States, 77030|
|Rigshospitalet||Not yet recruiting|
|København, Denmark, 2100|
|Hospital Sant Joan de Déu||Not yet recruiting|
|Barcelona, Spain, 08010|
|The Harley Street Clinic||Not yet recruiting|
|London, United Kingdom, W1G 7HL|