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ACNS1833: Selumetinib for Low-grade Glioma

About this study

Low-grade glioma is a type of brain tumor that can affect children and young adults. 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. Doctors want to find treatments that work well and cause fewer side effects.

This study is for patients who have not had chemotherapy or radiation therapy before. The tumor must not have a gene change called BRAF V600E and must not be linked to a condition called neurofibromatosis type 1 (NF1). Doctors test for these conditions and will talk with families about whether the study may be a good fit.

This study tests if a drug called selumetinib works as well as standard chemotherapy for 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 tell tumor cells 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 by mouth. Both groups are watched closely to manage side effects and keep patients safe. Researchers hope selumetinib may cause fewer problems than standard chemotherapy. They hope that it may 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, teens, and young adults with low-grade glioma. They also need to learn how these treatments affect children as they grow and develop.

Eligibility overview

  • 2–21 years old 
  • Has low-grade glioma that has not been treated with chemotherapy or radiation (with the exception of subependymal giant cell astrocytoma).
  • Tumor does not have a BRAF V600E mutation
  • Does not have neurofibromatosis type 1 (NF1)
  • Has measurable tumor after surgery or biopsy
  • Able to swallow medicine

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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:

ACNS1833: A Phase 3 Randomized Non‑Inferiority Study of Carboplatin and Vincristine versus Selumetinib in Newly Diagnosed or Previously Untreated Low‑grade Glioma

Study goal:

To compare selumetinib with carboplatin and vincristine for treating low‑grade glioma while evaluating tumor control and quality of life

Diagnosis:

Low‑grade glioma

Age:

2–21 years

Clinical trial categories:

Low-Grade Glioma

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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