Clinical trialNCT03871257Active, not recruitingPhase 3Interventional

A Study of the Drugs Selumetinib Versus Carboplatin/Vincristine in Patients With Neurofibromatosis and Low-Grade Glioma

SponsorNational Cancer Institute (NCI)Enrollment165Low Grade GliomaNeurofibromatosis Type 1Visual Pathway Glioma

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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. Chemotherapy drugs, 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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Jason R Fangusaro
Children's Oncology Group
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

132 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada

British Columbia Children'S Hospital
Vancouver, British Columbia, Canada
Iwk Health Centre
Halifax, Nova Scotia, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada
the Montreal Children'S Hospital of the Muhc
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Sherbrooke, Quebec, Canada

Puerto Rico

Hima San Pablo Oncologic Hospital
Caguas, Puerto Rico

United States

Children'S Hospital of Alabama
Birmingham, Alabama, United States
Banner Children'S at Desert
Mesa, Arizona, United States
Phoenix Childrens Hospital
Phoenix, Arizona, United States
Arkansas Children'S Hospital
Little Rock, Arkansas, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Children'S Hospital Los Angeles
Los Angeles, California, United States
Kaiser Permanente-Oakland
Oakland, California, United States
Children'S Hospital of Orange County
Orange, California, United States
Lucile Packard Children'S Hospital Stanford University
Palo Alto, California, United States
Naval Medical Center -San Diego
San Diego, California, United States
Rady Children'S Hospital - San Diego
San Diego, California, United States
Ucsf Medical Center-Mission Bay
San Francisco, California, United States
Children'S Hospital Colorado
Aurora, Colorado, United States
Connecticut Children'S Medical Center
Hartford, Connecticut, United States
Yale University
New Haven, Connecticut, United States
Alfred I Dupont Hospital for Children
Wilmington, Delaware, United States
Children'S National Medical Center
Washington D.C., District of Columbia, United States
Golisano Children'S Hospital of Southwest Florida
Fort Myers, Florida, United States
Uf Health Cancer Institute - Gainesville
Gainesville, Florida, United States
Memorial Regional Hospital/joe Dimaggio Children'S Hospital
Hollywood, Florida, United States
Nemours Children'S Clinic-Jacksonville
Jacksonville, Florida, United States
Nicklaus Children'S Hospital
Miami, Florida, United States
Adventhealth Orlando
Orlando, Florida, United States
Arnold Palmer Hospital for Children
Orlando, Florida, United States
Nemours Children'S Hospital
Orlando, Florida, United States
Sacred Heart Hospital
Pensacola, Florida, United States
Johns Hopkins All Children'S Hospital
St. Petersburg, Florida, United States
Saint Joseph'S Hospital/children'S Hospital-Tampa
Tampa, Florida, United States
Children'S Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
Saint Luke'S Cancer Institute - Boise
Boise, Idaho, United States
Lurie Children'S Hospital-Chicago
Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States

92 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Carboplatin →Selumetinib →Vincristine →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 15 Jan 2020
Primary completion: 31 Dec 2027
Completion: 31 Dec 2027
Last update posted: 13 Aug 2026
Registered enrollment: 165
Registry id: NCT03871257

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.