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iMATRIX: Alectinib for ALK Fusion–positive Cancers

About this study 

Children and teens with certain solid tumors, or tumors in the brain or spinal cord, may not get better with standard treatments. Some of these cancers have gene (DNA) changes called ALK fusions. These changes can help their cancer grow. When a treatment stops working, or there is no other treatment available, families and doctors need other choices. 

This study tests a medicine called alectinib. The medicine targets cancers with ALK fusions and has helped adults with similar cancers. Alectinib blocks signals that help cancer cells grow. This study is the first to test this medicine in children and teens. It has not yet been approved by the FDA for use in children. The goal is to learn if it is safe for these patients, how the body handles the alectinib, and if it may help those whose cancer has come back or has not responded to treatment. 

Participants take alectinib by mouth 2 times each day. It may be given as a capsule or a liquid. The dose is based on body weight. Doctors will watch patients closely for side effects, collect blood and urine samples to see how their bodies handle the medicine, DXA and x-ray to check their bones, and perform imaging tests or bone marrow biopsy (if needed) to see how their cancers respond to the medicine. Participants will also have genetic testing to look for gene changes will also be done on tumor tissue from a surgery or biopsy.  

The study is done in steps, starting with finding a safe dose and then treating more patients at that dose. 

Doctors will check if tumors shrink, stay the same, or grow. They will also track how long the cancer stays under control. Because children are still growing, the study will also watch growth, development, bone health, learning, and vision over time. 

What we learn from this study may help create new treatment options for children and teens with these hard-to-treat cancers. 

Eligibility overview 

  • Diagnosis of an ALK fusion–positive solid tumor or tumor of the brain or spinal cord 
  • Cancer has returned, has not responded to earlier treatment, or has no satisfactory standard treatment 
  • Younger than 18 years of age 
  • Able to swallow capsules or take liquid medicine by mouth or feeding tube 

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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:

iMATRIX: A Phase I/II, OpenLabel Study of Alectinib in Pediatric Patients with ALK Fusion–Positive Solid or CNS Tumors

Study goal:

To study how safe alectinib is and how well it treats ALK fusion–positive cancers in children and adolescents

Diagnosis:

Solid tumors, brain tumors

Age:

Younger than 18 years

Clinical trial categories:

Solid Tumors Brain Tumors

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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