A Phase III Study of Selumetinib with or without Vinblastine in Patients with Recurrent or Persistent Low-Grade Glioma

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Full Title

A Phase 3 Study of Selumetinib (NSC# 748727, IND# 77782) or Selumetinib in Combination with Vinblastine for non-NF1, non-TSC Patients with Recurrent or Progressive Low-Grade Gliomas (LGGs) Lacking BRAFV600E or IDH1 Mutations (ACNS1931) (CIRB)

Purpose

The purpose of this study is to see if adding vinblastine to treatment with the drug selumetinib is more effective than selumetinib alone for children and young adults with low-grade glioma (a common type of brain cancer) that has come back after prior treatment or does not respond to therapy. Selumetinib works by blocking a protein that lets tumor cells grow without stopping. Vinblastine blocks cell growth by stopping cell division and may kill cancer cells.

Patients in this study will be randomly assigned to receive selumetinib with or without vinblastine. Selumetinib is taken orally (by mouth) and vinblastine is given intravenously (by vein).

Eligibility

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

  • Patients must have low-grade glioma that came back or continued to grow despite treatment.
  • Patients should recover from the serious side effects of previous chemotherapy, immunotherapy, or radiation therapy before receiving the study treatment.
  • 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 2-25. Patients over age 21 must have had their initial glioma diagnosis before age 21.

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

Protocol

21-106

Phase

III

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators