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A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma

Comparing Selumetinib with Carboplatin/Vincristine for low-grade glioma.

Recruiting
2-21 years
All
Phase 3

The study is testing two treatments for low-grade glioma (LGG), a type of brain tumor, in children and young adults. One treatment uses selumetinib, a drug that blocks enzymes to stop tumor growth. The other uses carboplatin and vincristine (CV), which are chemotherapy drugs that either kill tumor cells or stop them from dividing. This study aims to see if selumetinib works as well as the CV treatment and if it improves the quality of life for patients.

  • Study Length: Up to 27 treatment cycles (28 days each), with follow-ups for up to 10 years.
  • Visits: Regular visits for blood tests and MRI scans.
  • Risks: Possible side effects from drugs; eligibility requires specific health criteria.

To join, patients need to be between 2 and 21 years old, have a specific type of LGG, and meet health requirements. They must not have received tumor-directed therapy before. Pregnant or breastfeeding females are not eligible. Participants need to agree to use contraception during and after the study. Regular check-ups and certain tests are required to ensure safety throughout the trial.

Study details
    Low Grade Astrocytoma
    Low Grade Glioma
    Metastatic Low Grade Astrocytoma
    Metastatic Low Grade Glioma

NCT04166409

National Cancer Institute (NCI)

11 May 2025

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