Neuroblastoma Treatment Using 131I-MIBG or Lorlatinib – Phase III

ANBL1531: Study of 131I-Metaiodobenzylguanidine or ALK Inhibitor Therapy Added to Intensive Therapy for Children with Newly Diagnosed High-Risk Neuroblastoma

Protocol Description

Through this Children's Oncology Group (COG) study, researchers are investigating whether they can improve the treatment for young people with high-risk neuroblastoma by adding either 131I- Metaiodobenzylguanidine (131I-MIBG) or lorlatinib to standard chemotherapy. Lorlatinib will be used specifically with patients whose tumors have shown a change in a gene called ALK.

Study Level: III

Eligibility Criteria

Subject to certain exclusion criteria, this study is enrolling patients ages 1 through 30 years at the time of their diagnosis with a high-risk neuroblastoma.
Males and Females: Ages 1 through 30 years

Requirements

Once a determination is made about their ALK gene, participants will be placed in a part of the study that compares treatment using 131I-MIGB to treatment via standard COG-recommended therapy (if no change in the gene); or treatment using Lorlatinib compared to standard COG-recommended therapy (if the gene has changed). Whether participants receive standard therapy or treatment with an experimental drug is determined by randomization.
Visits: Number varies by treatment group.
Duration: Varies by treatment group and will be either about 1-1/2 years or about 2-1/2 years for most participants.

Status: Open to Enrollment

Source(s) of Support

Children’s Oncology Group (ANBL1531)
National Cancer Institute

Primary Investigator

Jean M. Tersak, MD

Contact Information

For more information about the study or enrollment, please contact the UPMC Children’s Hospital of Pittsburgh Hematology-Oncology research team, at: HOCHPPhaseI-II@upmc.edu