About this trial
This trial looks at how well adding either iobenguane I-131 or lorlatinib to standard treatment helps children with high-risk neuroblastoma. Iobenguane I-131 is a radioactive drug that may target tumor cells while sparing normal cells. Lorlatinib may stop tumor cell growth by blocking certain enzymes. The main goal is to see if these additions improve outcomes for young patients with this type of cancer.
The trial's ID is NCT03126916. It is a Phase 3 trial, which means it is testing how well the treatments work and their safety. This trial is regulated by the FDA and aims to include about 750 participants.
Who can join
Children aged 1 to 30 years with newly diagnosed high-risk neuroblastoma can join. They should have specific features in their tumor that make them eligible. The trial is open to both boys and girls. The trial team will confirm if a child can participate based on these criteria.
Conditions
Ganglioneuroblastoma, Ganglioneuroblastoma, Nodular, Neuroblastoma
The study team makes the final call on eligibility.
What happens in the study
Participants will be randomly placed into different groups. Each group will receive a different combination of treatments which may include chemotherapy, radiation, stem cell transplantation, and either iobenguane I-131 or lorlatinib. Everyone will receive some form of intensive therapy, but the specific drugs or combinations will vary by group.
Where
This trial is running at 152 locations in the United States. 145 of them are currently recruiting.
AdventHealth Orlando
Orlando, Florida
Advocate Children's Hospital-Oak Lawn
Oak Lawn, Illinois
Advocate Children's Hospital-Park Ridge
Park Ridge, Illinois
Albany Medical Center
Albany, New York
Alfred I duPont Hospital for Children
Wilmington, Delaware
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada
Arkansas Children's Hospital
Little Rock, Arkansas
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas
The first 8 of 152 sites are listed here. The registry record has the full list.