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Protocol # 19-739

Status

Recruiting

Description

This phase III trial studies if selumetinib works just as well as the standard treatment with carboplatin/vincristine (CV) for subjects with NF1-associated low grade glioma (LGG), and to see if selumetinib is better than CV in improving vision in subjects with LGG of the optic pathway (vision nerves). Selumetinib is a drug that works by blocking some enzymes that low-grade glioma tumor cells need for their growth. This results in killing tumor cells. Drugs used as chemotherapy, such as carboplatin and vincristine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether selumetinib works better in treating patients with NF1-associated low-grade glioma compared to standard therapy with carboplatin and vincristine.

Condition

  • Low Grade Glioma
  • Neurofibromatosis Type 1
  • Visual Pathway Glioma

Interventions

  • Carboplatin
  • Quality-of-Life Assessment
  • Questionnaire Administration
  • Selumetinib Sulfate
  • Vincristine Sulfate

Phase

Phase 3

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Event-free survival (EFS)
  • Number of participants with visual acuity (VA) improvement per arm

Secondary Outcome:

  • Radiographic tumor response rate
  • Overall survival (OS)
  • Change in VA using HOTV letter acuity testing
  • Change in motor function
  • Change in quality of life (QOL)
  • Change in quality of life (QOL)
  • Change in executive function
  • Change in neurocognitive function

Enrollment

290

Study Start Date

October 4, 2019

Eligibility

  • Gender:     All
  • Minimum age:     2 Years
  • Maximum age:     21 Years
  • Healthy volunteers:     No

Sponsors

National Cancer Institute (NCI)

Source

National Cancer Institute (NCI)

Official title

A Phase 3 Randomized Study of Selumetinib Versus Carboplatin/Vincristine in Newly Diagnosed or Previously Untreated Neurofibromatosis Type 1 (NF1) Associated Low-Grade Glioma (LGG)

Clinicaltrials.gov Identifier

NCT03871257

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.