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A Study to Compare Treatment With the Drug Selumetinib Alone Versus Selumetinib and Vinblastine in Patients With Recurrent or Progressive Low-Grade Glioma

ACNS1931 - A Phase 3 Study of Selumetinib (NSC# 748727) 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

  • Clinical Trial Information

    Trial Contact: Leffin, Melissa; El-Shami, Jessica; Spinelli, Jennifer; Parker, Melanie; Short, Caitlyn

  • IRB No: ACNS1931

    Protocol Abbrev: ACNS1931

    Principal Investigator: Amy A Smith, MD

    Phase: Drug: Phase III

    Age Group: Adult;Pediatric

    Secondary Protocol No: ACNS1931

    Treatment: Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Drug: Selumetinib Sulfate, Drug: Vinblastine Sulfate

    Therapies Involved: Medication

    ClinicalTrials.gov ID: NCT04576117

  • Objective

    I. To determine the maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) of selumetinib sulfate (selumetinib) + vinblastine sulfate (vinblastine) for children with progressive or recurrent low-grade gliomas (LGGs).

    II. To determine if selumetinib + vinblastine will lead to improved event-free survival (EFS) outcome compared with selumetinib alone for children with progressive or recurrent LGGs.

  • Key Eligibility

    - Patients must be ≥ 2 years and ≤ 25 years of age at the time of enrollment on Step 0.
    - All patients > 21 years of age at the time of enrollment must have had initial diagnosis of low-grade glioma by 21 years of age.
    - Patient is suspected of having progressive or recurrent low-grade glioma (LGG).
    - Patient does not have a known diagnosis of neurofibromatosis type 1 (NF1) or tuberous sclerosis complex (TSC).