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ANBL1531, Arm E: Lorlatinib for High-Risk Neuroblastoma

About this study

High-risk neuroblastoma is a type of cancerous tumor that is hard to treat. Standard treatment usually includes: 

  • Chemotherapy to kill cancer cells
  • Surgery to remove cancer cells
  • 2 stem cell transplants to give higher doses of chemotherapy to kill cancer cells
  • Radiation to kill cancer cells
  • Immunotherapy to help the body’s immune system kill cancer cells

Even with all these treatments, some patients still have cancer that does not go away or comes back. 

Researchers wanted to see if adding new experimental medicines to this strong treatment plan could help children and young adults with neuroblastoma. The first medicine, 131I-MIBG, delivers radiation directly to cancer cells. The second medicine, lorlatinib, may help people whose tumors have a certain DNA change (mutation or amplification) in the ALK gene. Lorlatinib is a type of targeted therapy that may stop the growth of tumor cells that have an ALK mutation or amplification by blocking some of things the tumor cells need to grow. 

This study is trying to improve the chance of cure in 2 ways: 

  • The first treatment question added 131I-MIBG to the standard treatment. That part of the study is already closed, and the results are still unknown. 
  • This second treatment question, called Arm E, is still open. 

In Arm E, people whose neuroblastoma has an ALK mutation or amplification will receive lorlatinib plus the standard treatment for high-risk neuroblastoma. People will be able to receive treatment on this study if they were diagnosed with high-risk neuroblastoma and received 1 course of chemotherapy on another trial, ANBL2131. People treated with 1 cycle of chemotherapy on ANBL2131 whose tumors are identified as having an ALK mutation or amplification will be removed from ANBL2131 and offered treatment on ANBL1531 Arm E.  

People in this study will get all the standard treatments for high-risk neuroblastoma plus lorlatinib. They will have tests that may require blood, urine, and bone marrow samples. They will also have hearing tests and imaging scans such as x-rays. Participants may answer questions about how they feel and report any problems or side effects. Patients will take lorlatinib for 1 year after finishing these treatments.  

The goal of this study is to find out if adding lorlatinib to the usual treatment helps people with the ALK gene change have better results. Information from this study may help health care providers decide on the best treatments for people with high-risk neuroblastoma in the future.

Eligibility overview

  • Enrolled in ANBL2131
  • Have neuroblastoma
  • Have a certain ALK gene mutation
  • Between 365 days and 30 years old

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The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.

Overview

Full title:

ANBL1531: A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or ALK Inhibitor Therapy Added to Intensive Therapy for Children with Newly Diagnosed High-Risk Neuroblastoma 

Study goal:

To study the effect of adding lorlatinib to the usual treatment for neuroblastoma in people with ALK gene mutations 

Diagnosis:

Neuroblastoma

Age:

365 days to 30 years

Clinical trial categories:

Childhood Cancer Solid Tumors Neuroblastoma

For physicians and researchers

Patients accepted to St. Jude must be referred by a physician or other qualified medical professional. Learn how St. Jude can partner with you to care for your patient.

 

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