Clinical Trial Finder

131I-burtomab Radioimmunotherapy for Neuroblastoma Central Nervous System/Leptomeningeal Metastases

Study Purpose

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

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

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.

Study Type
Interventional
Eligible Ages N/A - 18 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.

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 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.
Patients with stable neurological deficits (due to brain tumor) are not excluded. Patients with Grade 3 or lower hearing loss are not excluded.

Trial Details

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.

Trial ID:
NCT03275402

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
Phase 2/Phase 3

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Y-mAbs Therapeutics

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Industry
Overall Status Not yet recruiting
Countries Denmark, Spain, United Kingdom, United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Neuroblastoma, CNS Metastases, Leptomeningeal Metastases
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Childrens Hospital Los Angeles, Los Angeles, California

Status

Not yet recruiting

Address

Childrens Hospital Los Angeles

Los Angeles, California, 90027

Site Contact

+4570261414

University of Florida, Gainesville, Florida

Status

Not yet recruiting

Address

University of Florida

Gainesville, Florida, 32611

Site Contact

+4570261414

Riley Hospital for Children, Indianapolis, Indiana

Status

Not yet recruiting

Address

Riley Hospital for Children

Indianapolis, Indiana, 46202

Site Contact

+4570261414

Memorial Sloan Kettering Cancer Center, New York, New York

Status

Not yet recruiting

Address

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Site Contact

+4570261414

Nationwide Children's Hospital, Columbus, Ohio

Status

Not yet recruiting

Address

Nationwide Children's Hospital

Columbus, Ohio, 43205

Site Contact

+4570261414

M.D. Anderson Cancer Center, Houston, Texas

Status

Not yet recruiting

Address

M.D. Anderson Cancer Center

Houston, Texas, 77030

Site Contact

+4570261414

International Sites

Rigshospitalet, København, Denmark

Status

Not yet recruiting

Address

Rigshospitalet

København, , 2100

Site Contact

+4570261414

Hospital Sant Joan de Déu, Barcelona, Spain

Status

Not yet recruiting

Address

Hospital Sant Joan de Déu

Barcelona, , 08010

Site Contact

+4570261414

The Harley Street Clinic, London, United Kingdom

Status

Not yet recruiting

Address

The Harley Street Clinic

London, , W1G 7HL

Site Contact

+4570261414

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