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ACNS1831: Selumetinib for NF1-related Low-grade Glioma

About this study 

Children with neurofibromatosis type 1 (NF1) can develop a brain tumor called a low-grade glioma. These tumors usually grow slowly, but they can cause problems with vision, movement, learning, and daily life. Some children need more treatment if surgery cannot remove all of the tumor or if the tumor starts to grow again.  

Most low-grade gliomas in NF1 patients are located in the optic pathway. So, removal of the tumor is not possible in most cases. Doctors want to find treatments that work well and cause fewer side effects. 

This study is for children and young adults with NF1-related low‑grade glioma. Doctors will review each patient’s medical history to see if the study may be a good fit. 

The study tests if a drug called selumetinib works as well as standard chemotherapy for NF1-related low-grade glioma. The standard chemotherapy drugs are carboplatin and vincristine. Chemotherapy attacks cancer cells but can also affect healthy cells and cause side effects. Selumetinib is a targeted therapy. It works by blocking signals that tumor cells need to grow.  

Patients are placed by chance (like flipping a coin) into 1 of 2 groups. This means each person has the same chance of being in either group. Neither families nor doctors choose the group.  

One group gets standard chemotherapy through a vein. The other group takes selumetinib as a liquid or capsule by mouth. Both groups are watched closely to manage side effects and keep patients safe. Researchers hope selumetinib may cause fewer problems and be easier for children to take.  

During the study, patients have MRI scans, blood tests, eye exams, and other health checks. Families and patients also answer questions about how the patient feels and does in daily life, school, and other activities. 

Researchers want to learn which treatment works better and is safer for children and young adults with NF1-related low-grade glioma. They also need to learn how these treatments affect children as they grow and develop. 

Eligibility overview 

  • 2 to 21 years old 
  • Has neurofibromatosis type 1 (NF1) 
  • Has a low‑grade glioma, including tumors of the optic pathway 
  • Tumor is newly diagnosed or has not been treated with chemotherapy or radiation 

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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:

ACNS1831: A Phase 3 Randomized Study of Selumetinib versus Carboplatin and Vincristine in Newly Diagnosed or Previously Untreated Neurofibromatosis Type 1–associated Low‑grade Glioma

Study goal:

To compare selumetinib and standard chemotherapy for treating NF1-related low-grade glioma in children and young adults

Diagnosis:

Neurofibromatosis Type 1, Low‑grade Glioma

Age:

2–21 years

Clinical trial categories:

Low-Grade Glioma Neurofibromatosis Type 1

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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