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

Titre officiel

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)

Sommaire:

Cet essai de phase III vise à évaluer l’efficacité du sélumétinib dans le traitement des patients atteints d’un gliome de bas grade. Le sélumétinib est un médicament qui agit en bloquant une protéine (un constituant de base de l’organisme) qui permet aux cellules tumorales de se développer librement. Les médicaments utilisés en chimiothérapie, comme le carboplatine et la vincristine, agissent de différentes manières pour arrêter la croissance des cellules tumorales, soit en tuant les cellules soit en les empêchant de se diviser ou de se propager. Cet essai vise à déterminer si le sélumétinib est efficace, au même titre que le carboplatine et la vincristine, pour éliminer ou réduire les gliomes de bas grade et empêcher leur récidive.

Description de l'essai

Primary Outcome:

  • Event-free survival (EFS)
Secondary Outcome:
  • Radiographic tumour response rate
  • Overall survival (OS)
  • Proportion of patients who experience an improvement in visual acuity (VA)
  • Motor function assessment
  • Change in parent and patient-reported quality of life (QOL) over time
PRIMARY OBJECTIVE:
  • To demonstrate that the efficacy of treatment with selumetinib as measured by event-free survival (EFS) is non-inferior compared to treatment with carboplatin/vincristine (CV) in previously-untreated low-grade glioma (LGG) not associated with BRAFV600E mutations or systemic neurofibromatosis type 1 (NF1).
SECONDARY OBJECTIVES:
  • To estimate tumour response rates to each regimen of chemotherapy.
  • To evaluate visual acuity (VA) outcomes utilizing Teller Acuity Cards (TAC) and HOTV letter acuity testing in previously-untreated optic pathway gliomas (OPGs).
  • To describe the improvement in motor function as measured by the Vineland Scale in children with previously-untreated LGG that have motor deficits at enrollment.
  • To estimate the difference in EFS and tumour response rate between BRAF rearranged and non-BRAF rearranged patients treated on each chemotherapy regimen.
  • To prospectively evaluate the quality of life of children with LGG not associated with BRAFV600E or systemic NF1 treated with either CV or selumetinib.
  • To prospectively evaluate the cognitive, social, emotional, and behavioural functioning of children with LGG not associated with BRAFV600E or systemic NF1 treated with either CV or selumetinib.
EXPLORATORY OBJECTIVE:
  • To obtain paired blood and tumour specimens for future biology studies, including studies to correlate genomic drivers to response.
OUTLINE:
Patients are randomized to 1 of 2 arms.

ARM I: INDUCTION: Patients receive vincristine sulfate intravenously (IV) over 1 minute on days 1, 8, 15, 22, 29, 36, 43, 50, 57, and 64, and carboplatin IV over 60 minutes on days 1, 8, 15, 22, 43, 50, 57, and 64 in the absence of disease progression or unacceptable toxicity.

MAINTENANCE: Patients receive vincristine sulfate IV over 1 minute on days 1, 8, and 15, and carboplatin IV over 60 minutes on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive selumetinib sulfate orally (PO) twice daily (BID) on days 1-28. Treatment repeats every 28 days for up to 27 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for year 1, every 6 months for years 2-3, and then annually for years 4-10.

Voir cet essai sur ClinicalTrials.gov

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