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Low Grade AstrocytomaChildren's healthProcedureDrugPhase 3

What this study is

This phase III trial compares the effect of selumetinib versus the standard of care treatment with carboplatin and vincristine (CV) in treating patients with newly diagnosed or previously untreated low-grade glioma (LGG) that does not have a genetic abnormality called BRAFV600E mutation and is not associated with systemic neurofibromatosis type 1. Selumetinib works by blocking some of the enzymes needed for cell growth and may kill tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Vincristine is in a class of medications called vinca alkaloids. It works by stopping tumor cells from growing and dividing and may kill them. The overall goal of this study is to see if selumetinib works just as well as the standard treatment of CV for patients with LGG. Another goal of this study is to compare the effects of selumetinib versus CV in subjects with LGG to find out which is better. Additionally, this trial will also examine if treatment with selumetinib improves the quality of life for subjects who take it.

What's being tested

  • Biospecimen Collection

    Intervention · PROCEDURE

    Undergo blood sample collection

  • Carboplatin

    Intervention · DRUG

  • Echocardiography Test

    Intervention · PROCEDURE

    Undergo ECHO

  • Magnetic Resonance Imaging

    Intervention · PROCEDURE

    Undergo MRI

  • Questionnaire Administration

    Intervention · OTHER

    Ancillary studies

  • Selumetinib Sulfate

    Intervention · DRUG

    Given PO

  • Vincristine Sulfate

    Intervention · DRUG

Both Carboplatin and Vincristine Sulfate

Given IV

Study details

Official title
A Phase 3 Randomized Non-Inferiority Study of Carboplatin and Vincristine Versus Selumetinib (NSC# 748727) in Newly Diagnosed or Previously Untreated Low-Grade Glioma (LGG) Not Associated With BRAFV600E Mutations or Systemic Neurofibromatosis Type 1 (NF1)
Sponsor
National Cancer Institute (NCI)
Conditions
Low Grade Astrocytoma · Low Grade Glioma · Metastatic Low Grade Astrocytoma · Metastatic Low Grade Glioma · WHO Grade 1 Glioma · WHO Grade 2 Glioma
Enrolling
170 people
Starts
2020-01-31
Est. completion
2030-12-31
Design
Open-label, randomized, parallel groups, Phase 3
Record
View on ClinicalTrials.gov ↗