A Phase III Study of Selumetinib versus Carboplatin/Vincristine in Patients with Low-Grade Glioma

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Full Title

A Phase 3 Randomized Non-Inferiority Study of Carboplatin and Vincristine Versus Selumetinib (NSC# 748727, IND# 77782) in Newly Diagnosed or Previously Untreated Low-Grade Glioma Not Associated with BRAFV600E Mutations or Systemic Neurofibromatosis Type 1 (NF1) (ACNS1833) (CIRB)

Purpose

Although most low-grade gliomas are treatable, doctors want to improve treatments by reducing side effects and improving patients’ quality of life during treatment. The standard therapy, carboplatin and vincristine (CV), is given intravenously (by vein) over 15 months and requires multiple clinic visits to receive treatment.

In this study, researchers want to see if the drug selumetinib works as well as CV for patients with low-grade glioma. Selumetinib is taken orally (by mouth). It works by blocking proteins needed for cell growth and killing cancer cells. Patients in this study will be randomly assigned to receive either standard CV therapy for 15 months or selumetinib for 27 months.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have LGG that does not contain BRAF V600E mutations and is not associated with neurofibromatosis type 1.
  • Patients may not have received any prior treatment for LGG other than surgery.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients ages 2-21.

For more information about this study and to inquire about eligibility, please contact 1-833-MSK-KIDS.

Protocol

20-529

Phase

III

Investigator

Co-Investigators