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En studie av läkemedlen Selumetinib vs. Carboplatin och Vincristine hos patienter med låggradigt gliom

5 november 2026 uppdaterad av: National Cancer Institute (NCI)

En fas 3 randomiserad non-inferioritetsstudie av karboplatin och vinkristin kontra selumetinib (NSC# 748727) i nydiagnostiserade eller tidigare obehandlade låggradigt gliom (LGG) som inte är associerade med BRAFV600E-mutationer eller systemisk neurofibromatos typ 1

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

PRIMARY OBJECTIVE:

I. 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:

I. To estimate tumor response rates to each regimen of chemotherapy. II. To evaluate visual acuity (VA) outcomes utilizing Teller Acuity Cards (TAC) and HOTV letter acuity testing in previously-untreated optic pathway gliomas (OPGs).

III. 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.

IV. To estimate the difference in EFS and tumor response rate between BRAF rearranged and non-BRAF rearranged patients treated on each chemotherapy regimen.

V. To prospectively evaluate the quality of life of children with LGG not associated with BRAFV600E or systemic NF1 treated with either CV or selumetinib.

VI. To prospectively evaluate the cognitive, social, emotional, and behavioral functioning of children with LGG not associated with BRAFV600E or systemic NF1 treated with either CV or selumetinib.

EXPLORATORY OBJECTIVE:

I. To obtain paired blood and tumor specimens for future biology studies as well as data from Molecular Characterization Initiative (MCI) testing, to correlate genomic drivers to efficacy outcomes.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I:

INDUCTION: Patients receive vincristine sulfate intravenously (IV) 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. Patients also undergo collection of blood and magnetic resonance imaging (MRI) throughout the trial.

MAINTENANCE: Patients receive vincristine sulfate IV on days 1, 8, and 15, and carboplatin IV over 60 minutes on days 1, 8, 15, and 22 of each cycle. Cycles repeat every 42 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood and MRI throughout the trial.

ARM II: Patients receive selumetinib sulfate orally (PO) twice daily (BID) on days 1-28 of each cycle. Cycles repeat every 28 days for up to 27 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo echocardiography (ECHO) at baseline and undergo collection of blood and MRI throughout the trial.

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

170

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Alabama
      • Birmingham, Alabama, Förenta staterna, 35233
        • Rekrytering
        • Children's Hospital of Alabama
        • Kontakt:
        • Huvudutredare:
          • Laura K. Metrock
    • Arizona
      • Mesa, Arizona, Förenta staterna, 85202
        • Rekrytering
        • Banner Children's at Desert
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 480-412-3100
        • Huvudutredare:
          • Joseph C. Torkildson
      • Phoenix, Arizona, Förenta staterna, 85016
        • Rekrytering
        • Phoenix Childrens Hospital
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 602-546-0920
        • Huvudutredare:
          • Kazuhiro Sabet
    • Arkansas
      • Little Rock, Arkansas, Förenta staterna, 72202-3591
        • Rekrytering
        • Arkansas Children's Hospital
        • Huvudutredare:
          • Michael W. Bishop
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 501-364-7373
    • California
      • Loma Linda, California, Förenta staterna, 92354
        • Rekrytering
        • Loma Linda University Medical Center
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 909-558-4050
        • Huvudutredare:
          • Albert Kheradpour
      • Long Beach, California, Förenta staterna, 90806
        • Rekrytering
        • Miller Children's and Women's Hospital Long Beach
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 562-933-5600
        • Huvudutredare:
          • Jacqueline N. Casillas
      • Los Angeles, California, Förenta staterna, 90027
        • Rekrytering
        • Children's Hospital Los Angeles
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 323-361-4110
        • Huvudutredare:
          • Nathan J. Robison
      • Los Angeles, California, Förenta staterna, 90048
        • Rekrytering
        • Cedars-Sinai Medical Center
        • Huvudutredare:
          • Fataneh (Fae) Majlessipour
        • Kontakt:
      • Los Angeles, California, Förenta staterna, 90095
        • Rekrytering
        • Mattel Children's Hospital UCLA
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 310-825-6708
        • Huvudutredare:
          • Satiro N. De Oliveira
      • Oakland, California, Förenta staterna, 94611
        • Rekrytering
        • Kaiser Permanente-Oakland
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 877-642-4691
          • E-post: Kpoct@kp.org
        • Huvudutredare:
          • Aarati V. Rao
      • Orange, California, Förenta staterna, 92868
        • Rekrytering
        • Children's Hospital of Orange County
        • Kontakt:
        • Huvudutredare:
          • Elyssa M. Rubin
      • Palo Alto, California, Förenta staterna, 94304
        • Rekrytering
        • Lucile Packard Children's Hospital Stanford University
        • Kontakt:
        • Huvudutredare:
          • Jay Michael S. Balagtas
      • San Diego, California, Förenta staterna, 92123
        • Rekrytering
        • Rady Children's Hospital - San Diego
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 858-966-5934
        • Huvudutredare:
          • William D. Roberts
      • San Francisco, California, Förenta staterna, 94158
        • Rekrytering
        • UCSF Medical Center-Mission Bay
        • Kontakt:
        • Huvudutredare:
          • Alyssa T. Reddy
    • Colorado
      • Aurora, Colorado, Förenta staterna, 80045
        • Rekrytering
        • Children's Hospital Colorado
        • Huvudutredare:
          • Jean M. Mulcahy Levy
        • Kontakt:
    • Connecticut
      • Hartford, Connecticut, Förenta staterna, 06106
        • Rekrytering
        • Connecticut Children's Medical Center
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 860-545-9981
        • Huvudutredare:
          • Michael S. Isakoff
      • New Haven, Connecticut, Förenta staterna, 06520
        • Rekrytering
        • Yale University
        • Huvudutredare:
          • Asher M. Marks
        • Kontakt:
    • Delaware
      • Wilmington, Delaware, Förenta staterna, 19803
        • Rekrytering
        • Alfred I duPont Hospital for Children
        • Kontakt:
        • Huvudutredare:
          • Sridhi Patel
    • District of Columbia
      • Washington D.C., District of Columbia, Förenta staterna, 20010
        • Rekrytering
        • Children's National Medical Center
        • Huvudutredare:
          • Jeffrey S. Dome
        • Kontakt:
    • Florida
      • Fort Myers, Florida, Förenta staterna, 33908
        • Rekrytering
        • Golisano Children's Hospital of Southwest Florida
        • Kontakt:
        • Huvudutredare:
          • Emad K. Salman
      • Gainesville, Florida, Förenta staterna, 32610
        • Aktiv, inte rekryterande
        • UF Health Cancer Institute - Gainesville
      • Hollywood, Florida, Förenta staterna, 33021
        • Rekrytering
        • Memorial Regional Hospital/Joe DiMaggio Children's Hospital
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 954-265-1847
          • E-post: OHR@mhs.net
        • Huvudutredare:
          • Iftikhar Hanif
      • Jacksonville, Florida, Förenta staterna, 32207
        • Rekrytering
        • Nemours Children's Clinic-Jacksonville
        • Kontakt:
        • Huvudutredare:
          • Sridhi Patel
      • Miami, Florida, Förenta staterna, 33155
        • Rekrytering
        • Nicklaus Children's Hospital
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 888-624-2778
        • Huvudutredare:
          • Ziad A. Khatib
      • Miami, Florida, Förenta staterna, 33136
        • Indragen
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
      • Orlando, Florida, Förenta staterna, 32806
        • Rekrytering
        • Arnold Palmer Hospital for Children
        • Kontakt:
        • Huvudutredare:
          • Zhongbo Hu
      • Orlando, Florida, Förenta staterna, 32827
        • Rekrytering
        • Nemours Children's Hospital
        • Kontakt:
        • Huvudutredare:
          • Sridhi Patel
      • Orlando, Florida, Förenta staterna, 32803
        • Rekrytering
        • AdventHealth Orlando
        • Kontakt:
        • Huvudutredare:
          • Fouad M. Hajjar
      • Pensacola, Florida, Förenta staterna, 32504
        • Upphängd
        • Sacred Heart Hospital
      • Pensacola, Florida, Förenta staterna, 32504
      • St. Petersburg, Florida, Förenta staterna, 33701
        • Rekrytering
        • Johns Hopkins All Children's Hospital
        • Kontakt:
        • Huvudutredare:
          • Stacie L. Stapleton
      • Tampa, Florida, Förenta staterna, 33607
        • Rekrytering
        • Saint Joseph's Hospital/Children's Hospital-Tampa
        • Kontakt:
        • Huvudutredare:
          • Don E. Eslin
    • Georgia
      • Atlanta, Georgia, Förenta staterna, 30329
        • Rekrytering
        • Children's Healthcare of Atlanta - Arthur M Blank Hospital
        • Huvudutredare:
          • Jason R. Fangusaro
        • Kontakt:
    • Hawaii
      • Honolulu, Hawaii, Förenta staterna, 96826
        • Rekrytering
        • Kapiolani Medical Center for Women and Children
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 808-983-6090
        • Huvudutredare:
          • Wade T. Kyono
    • Idaho
      • Boise, Idaho, Förenta staterna, 83712
        • Rekrytering
        • Saint Luke's Cancer Institute - Boise
        • Huvudutredare:
          • Martha M. Pacheco
        • Kontakt:
    • Illinois
      • Chicago, Illinois, Förenta staterna, 60611
        • Rekrytering
        • Lurie Children's Hospital-Chicago
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 773-880-4562
        • Huvudutredare:
          • Angela J. Waanders
      • Chicago, Illinois, Förenta staterna, 60637
        • Rekrytering
        • University of Chicago Comprehensive Cancer Center
        • Kontakt:
        • Huvudutredare:
          • Wendy S. Darlington
      • Chicago, Illinois, Förenta staterna, 60612
        • Rekrytering
        • University of Illinois
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 312-355-3046
        • Huvudutredare:
          • Dipti S. Dighe
      • Peoria, Illinois, Förenta staterna, 61637
      • Springfield, Illinois, Förenta staterna, 62702
        • Rekrytering
        • Southern Illinois University School of Medicine
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 217-545-7929
        • Huvudutredare:
          • Gregory P. Brandt
    • Indiana
      • Indianapolis, Indiana, Förenta staterna, 46202
        • Rekrytering
        • Riley Hospital for Children
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 800-248-1199
        • Huvudutredare:
          • Sandeep Batra
      • Indianapolis, Indiana, Förenta staterna, 46260
        • Rekrytering
        • Ascension Saint Vincent Indianapolis Hospital
        • Kontakt:
        • Huvudutredare:
          • Jessica F. Goodman
    • Iowa
      • Des Moines, Iowa, Förenta staterna, 50309
        • Rekrytering
        • Blank Children's Hospital
        • Kontakt:
        • Huvudutredare:
          • Samantha L. Mallory
      • Iowa City, Iowa, Förenta staterna, 52242
        • Rekrytering
        • University of Iowa/Holden Comprehensive Cancer Center
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 800-237-1225
        • Huvudutredare:
          • Andrew P. Groves
    • Kentucky
      • Lexington, Kentucky, Förenta staterna, 40536
        • Rekrytering
        • University of Kentucky/Markey Cancer Center
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 859-257-3379
        • Huvudutredare:
          • James T. Badgett
      • Louisville, Kentucky, Förenta staterna, 40202
        • Rekrytering
        • Norton Children's Hospital
        • Kontakt:
        • Huvudutredare:
          • Michael J. Ferguson
    • Louisiana
      • New Orleans, Louisiana, Förenta staterna, 70118
        • Rekrytering
        • Children's Hospital New Orleans
        • Huvudutredare:
          • Maria C. Velez-Yanguas
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 504-894-5377
    • Maine
      • Bangor, Maine, Förenta staterna, 04401
        • Rekrytering
        • Eastern Maine Medical Center
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 207-973-4274
        • Huvudutredare:
          • Daniel L. Callaway
      • Scarborough, Maine, Förenta staterna, 04074
        • Rekrytering
        • Maine Children's Cancer Program
        • Huvudutredare:
          • Stanley Chaleff
        • Kontakt:
    • Maryland
      • Baltimore, Maryland, Förenta staterna, 21287
        • Rekrytering
        • Johns Hopkins University/Sidney Kimmel Cancer Center
        • Kontakt:
        • Huvudutredare:
          • Kenneth J. Cohen
      • Bethesda, Maryland, Förenta staterna, 20889-5600
        • Rekrytering
        • Walter Reed National Military Medical Center
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 301-319-2100
        • Huvudutredare:
          • Kip R. Hartman
    • Massachusetts
      • Boston, Massachusetts, Förenta staterna, 02215
        • Aktiv, inte rekryterande
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, Förenta staterna, 02114
        • Aktiv, inte rekryterande
        • Massachusetts General Hospital Cancer Center
    • Michigan
      • Ann Arbor, Michigan, Förenta staterna, 48109
        • Rekrytering
        • C S Mott Children's Hospital
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 800-865-1125
        • Huvudutredare:
          • Andrea T. Franson
      • Detroit, Michigan, Förenta staterna, 48201
      • Grand Rapids, Michigan, Förenta staterna, 49503
        • Rekrytering
        • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
        • Kontakt:
        • Huvudutredare:
          • Kathleen Y. Butler
      • Royal Oak, Michigan, Förenta staterna, 48073
        • Aktiv, inte rekryterande
        • Corewell Health Children's
    • Minnesota
      • Minneapolis, Minnesota, Förenta staterna, 55404
        • Rekrytering
        • Children's Hospitals and Clinics of Minnesota - Minneapolis
        • Huvudutredare:
          • Michael K. Richards
        • Kontakt:
      • Minneapolis, Minnesota, Förenta staterna, 55455
        • Rekrytering
        • University of Minnesota/Masonic Cancer Center
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 612-624-2620
        • Huvudutredare:
          • Clay M. Hoerig
      • Rochester, Minnesota, Förenta staterna, 55905
        • Rekrytering
        • Mayo Clinic in Rochester
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 855-776-0015
        • Huvudutredare:
          • Joseph Z. Wilson
    • Mississippi
      • Jackson, Mississippi, Förenta staterna, 39216
        • Rekrytering
        • University of Mississippi Medical Center
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 601-815-6700
        • Huvudutredare:
          • Amanda Strobel
    • Missouri
      • Kansas City, Missouri, Förenta staterna, 64108
        • Rekrytering
        • Children's Mercy Hospitals and Clinics
        • Huvudutredare:
          • Keith J. August
        • Kontakt:
      • St Louis, Missouri, Förenta staterna, 63110
        • Rekrytering
        • Washington University School of Medicine
        • Kontakt:
        • Huvudutredare:
          • Andrew S. Cluster
      • St Louis, Missouri, Förenta staterna, 63104
        • Rekrytering
        • Cardinal Glennon Children's Medical Center
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 314-268-4000
        • Huvudutredare:
          • William S. Ferguson
    • Nebraska
      • Omaha, Nebraska, Förenta staterna, 68114
        • Rekrytering
        • Children's Hospital and Medical Center of Omaha
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 402-955-3949
        • Huvudutredare:
          • Jill C. Beck
      • Omaha, Nebraska, Förenta staterna, 68198
        • Rekrytering
        • University of Nebraska Medical Center
        • Kontakt:
        • Huvudutredare:
          • Jill C. Beck
    • New Jersey
      • Morristown, New Jersey, Förenta staterna, 07960
        • Rekrytering
        • Morristown Medical Center
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 973-971-5900
        • Huvudutredare:
          • Kathryn L. Laurie
    • New York
      • Albany, New York, Förenta staterna, 12208
        • Rekrytering
        • Albany Medical Center
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 518-262-5513
        • Huvudutredare:
          • Lauren R. Weintraub
      • Buffalo, New York, Förenta staterna, 14263
        • Rekrytering
        • Roswell Park Cancer Institute
        • Kontakt:
        • Huvudutredare:
          • Matthew J. Barth
      • Mineola, New York, Förenta staterna, 11501
        • Rekrytering
        • NYU Langone Hospital - Long Island
        • Kontakt:
        • Huvudutredare:
          • Chana L. Glasser
      • New Hyde Park, New York, Förenta staterna, 11040
        • Rekrytering
        • The Steven and Alexandra Cohen Children's Medical Center of New York
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 718-470-3460
        • Huvudutredare:
          • Mark P. Atlas
      • New York, New York, Förenta staterna, 10065
        • Rekrytering
        • Memorial Sloan Kettering Cancer Center
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 212-639-7592
        • Huvudutredare:
          • Sameer Farouk Sait
      • New York, New York, Förenta staterna, 10016
        • Rekrytering
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone
        • Huvudutredare:
          • Elizabeth A. Raetz
        • Kontakt:
      • Rochester, New York, Förenta staterna, 14642
        • Aktiv, inte rekryterande
        • University of Rochester
      • Syracuse, New York, Förenta staterna, 13210
        • Rekrytering
        • State University of New York Upstate Medical University
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 315-464-5476
        • Huvudutredare:
          • Melanie A. Comito
      • Valhalla, New York, Förenta staterna, 10595
        • Rekrytering
        • New York Medical College
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 914-594-3794
        • Huvudutredare:
          • Andrew J. Bellantoni
    • North Carolina
      • Chapel Hill, North Carolina, Förenta staterna, 27599
        • Rekrytering
        • UNC Lineberger Comprehensive Cancer Center
        • Kontakt:
        • Huvudutredare:
          • David E. Kram
      • Charlotte, North Carolina, Förenta staterna, 28203
        • Rekrytering
        • Carolinas Medical Center/Levine Cancer Institute
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 800-804-9376
        • Huvudutredare:
          • Joel A. Kaplan
      • Durham, North Carolina, Förenta staterna, 27710
        • Rekrytering
        • Duke University Medical Center
        • Huvudutredare:
          • Jessica M. Sun
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 888-275-3853
      • Greenville, North Carolina, Förenta staterna, 27834
        • Rekrytering
        • East Carolina University
        • Kontakt:
        • Huvudutredare:
          • Andrea R. Whitfield
      • Winston-Salem, North Carolina, Förenta staterna, 27157
        • Rekrytering
        • Wake Forest University Health Sciences
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 336-713-6771
        • Huvudutredare:
          • Sarah Supples
    • North Dakota
      • Fargo, North Dakota, Förenta staterna, 58122
    • Ohio
      • Akron, Ohio, Förenta staterna, 44308
        • Rekrytering
        • Children's Hospital Medical Center of Akron
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 330-543-3193
        • Huvudutredare:
          • Lauren R. Draper
      • Cincinnati, Ohio, Förenta staterna, 45229
        • Rekrytering
        • Cincinnati Children's Hospital Medical Center
        • Kontakt:
        • Huvudutredare:
          • Peter M. de Blank
      • Cleveland, Ohio, Förenta staterna, 44106
        • Rekrytering
        • Rainbow Babies and Childrens Hospital
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 216-844-5437
        • Huvudutredare:
          • Duncan S. Stearns
      • Columbus, Ohio, Förenta staterna, 43205
      • Dayton, Ohio, Förenta staterna, 45404
        • Rekrytering
        • Dayton Children's Hospital
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 800-228-4055
        • Huvudutredare:
          • Jordan M. Wright
    • Oklahoma
      • Oklahoma City, Oklahoma, Förenta staterna, 73104
        • Rekrytering
        • University of Oklahoma Health Sciences Center
        • Kontakt:
        • Huvudutredare:
          • Rene Y. McNall-Knapp
    • Oregon
      • Portland, Oregon, Förenta staterna, 97239
        • Rekrytering
        • Oregon Health and Science University
        • Kontakt:
        • Huvudutredare:
          • Neha J. Patel
    • Pennsylvania
      • Danville, Pennsylvania, Förenta staterna, 17822
        • Rekrytering
        • Geisinger Medical Center
        • Huvudutredare:
          • Jagadeesh Ramdas
        • Kontakt:
      • Hershey, Pennsylvania, Förenta staterna, 17033
        • Rekrytering
        • Penn State Children's Hospital
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 717-531-6012
        • Huvudutredare:
          • Lisa M. McGregor
      • Philadelphia, Pennsylvania, Förenta staterna, 19104
        • Rekrytering
        • Children's Hospital of Philadelphia
        • Huvudutredare:
          • Michael J. Fisher
        • Kontakt:
      • Philadelphia, Pennsylvania, Förenta staterna, 19134
        • Rekrytering
        • Saint Christopher's Hospital for Children
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 215-427-8991
        • Huvudutredare:
          • Gregory E. Halligan
      • Pittsburgh, Pennsylvania, Förenta staterna, 15224
        • Rekrytering
        • Children's Hospital of Pittsburgh of UPMC
        • Kontakt:
        • Huvudutredare:
          • James T. Felker
    • Rhode Island
      • Providence, Rhode Island, Förenta staterna, 02903
        • Rekrytering
        • Rhode Island Hospital
        • Huvudutredare:
          • Bradley DeNardo
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 401-444-1488
    • South Carolina
      • Charleston, South Carolina, Förenta staterna, 29425
        • Rekrytering
        • Medical University of South Carolina
        • Kontakt:
        • Huvudutredare:
          • Jacqueline M. Kraveka
      • Columbia, South Carolina, Förenta staterna, 29203
        • Rekrytering
        • Prisma Health Richland Hospital
        • Huvudutredare:
          • Stuart L. Cramer
        • Kontakt:
      • Greenville, South Carolina, Förenta staterna, 29605
        • Rekrytering
        • BI-LO Charities Children's Cancer Center
        • Huvudutredare:
          • Aniket Saha
        • Kontakt:
    • Tennessee
      • Knoxville, Tennessee, Förenta staterna, 37916
        • Rekrytering
        • East Tennessee Childrens Hospital
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 865-541-8266
        • Huvudutredare:
          • Susan E. Spiller
      • Memphis, Tennessee, Förenta staterna, 38105
        • Rekrytering
        • Saint Jude Children's Research Hospital
        • Huvudutredare:
          • Anna Vinitsky
        • Kontakt:
      • Nashville, Tennessee, Förenta staterna, 37232
        • Rekrytering
        • Vanderbilt University/Ingram Cancer Center
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 800-811-8480
        • Huvudutredare:
          • Devang J. Pastakia
    • Texas
      • Austin, Texas, Förenta staterna, 78723
      • Dallas, Texas, Förenta staterna, 75390
        • Rekrytering
        • UT Southwestern/Simmons Cancer Center-Dallas
        • Kontakt:
        • Huvudutredare:
          • Daniel C. Bowers
      • El Paso, Texas, Förenta staterna, 79905
        • Rekrytering
        • El Paso Children's Hospital
        • Kontakt:
        • Huvudutredare:
          • Benjamin Carcamo
      • Fort Worth, Texas, Förenta staterna, 76104
      • Houston, Texas, Förenta staterna, 77030
        • Rekrytering
        • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
        • Huvudutredare:
          • Murali M. Chintagumpala
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 713-798-1354
          • E-post: burton@bcm.edu
      • Houston, Texas, Förenta staterna, 77030
        • Rekrytering
        • UT MD Anderson Cancer Center
        • Kontakt:
        • Huvudutredare:
          • Najat C. Daw
      • Lubbock, Texas, Förenta staterna, 79410
        • Rekrytering
        • Covenant Children's Hospital
        • Huvudutredare:
          • Kishor M. Bhende
        • Kontakt:
      • Lubbock, Texas, Förenta staterna, 79415
        • Rekrytering
        • UMC Cancer Center / UMC Health System
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 806-775-8590
        • Huvudutredare:
          • Erin K. Barr
      • San Antonio, Texas, Förenta staterna, 78207
        • Rekrytering
        • Children's Hospital of San Antonio
        • Kontakt:
        • Huvudutredare:
          • Julie Voeller
      • San Antonio, Texas, Förenta staterna, 78229
        • Rekrytering
        • University of Texas Health Science Center at San Antonio
        • Kontakt:
        • Huvudutredare:
          • Shafqat Shah
      • San Antonio, Texas, Förenta staterna, 78229
        • Rekrytering
        • Methodist Children's Hospital of South Texas
        • Kontakt:
        • Huvudutredare:
          • Jose M. Esquilin
    • Utah
      • Salt Lake City, Utah, Förenta staterna, 84113
        • Rekrytering
        • Primary Children's Hospital
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 801-585-5270
        • Huvudutredare:
          • Priya Chan
    • Vermont
      • Burlington, Vermont, Förenta staterna, 05405
        • Rekrytering
        • University of Vermont and State Agricultural College
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 802-656-8990
          • E-post: rpo@uvm.edu
        • Huvudutredare:
          • Jessica L. Heath
    • Virginia
      • Norfolk, Virginia, Förenta staterna, 23507
        • Rekrytering
        • Children's Hospital of The King's Daughters
        • Kontakt:
        • Huvudutredare:
          • Melissa S. Mark
      • Richmond, Virginia, Förenta staterna, 23298
        • Rekrytering
        • VCU Massey Comprehensive Cancer Center
        • Huvudutredare:
          • Christopher Park
        • Kontakt:
      • Roanoke, Virginia, Förenta staterna, 24014
        • Rekrytering
        • Carilion Children's
        • Kontakt:
        • Huvudutredare:
          • Erwood G. Edwards
    • Washington
      • Seattle, Washington, Förenta staterna, 98105
        • Rekrytering
        • Seattle Children's Hospital
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 866-987-2000
        • Huvudutredare:
          • Sarah E. Leary
      • Spokane, Washington, Förenta staterna, 99204
        • Rekrytering
        • Providence Sacred Heart Medical Center and Children's Hospital
        • Kontakt:
        • Huvudutredare:
          • Judy L. Felgenhauer
      • Tacoma, Washington, Förenta staterna, 98405
        • Rekrytering
        • Mary Bridge Children's Hospital and Health Center
        • Kontakt:
        • Huvudutredare:
          • Robert G. Irwin
      • Tacoma, Washington, Förenta staterna, 98431
        • Rekrytering
        • Madigan Army Medical Center
        • Huvudutredare:
          • Melissa A. Forouhar
        • Kontakt:
    • West Virginia
      • Morgantown, West Virginia, Förenta staterna, 26506
        • Rekrytering
        • West Virginia University Healthcare
        • Kontakt:
        • Huvudutredare:
          • Ashley E. Meyer
    • Wisconsin
      • Madison, Wisconsin, Förenta staterna, 53792
        • Rekrytering
        • University of Wisconsin Carbone Cancer Center - University Hospital
        • Kontakt:
        • Huvudutredare:
          • Nicholas J. Pytel
      • Milwaukee, Wisconsin, Förenta staterna, 53226
        • Rekrytering
        • Children's Hospital of Wisconsin
        • Kontakt:
        • Huvudutredare:
          • Sarah Rumler
  • Kanada
      • Québec, Kanada, G1V 4G2
        • Rekrytering
        • CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
        • Huvudutredare:
          • Bruno Michon
        • Kontakt:
    • British Columbia
      • Vancouver, British Columbia, Kanada, V6H 3V4
        • Rekrytering
        • British Columbia Children's Hospital
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 6477 604-875-2345
        • Huvudutredare:
          • Rebecca J. Deyell
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Kanada, A1B 3V6
        • Rekrytering
        • Janeway Child Health Centre
        • Huvudutredare:
          • Lisa A. Goodyear
        • Kontakt:
    • Nova Scotia
      • Halifax, Nova Scotia, Kanada, B3K 6R8
        • Rekrytering
        • IWK Health Centre
        • Kontakt:
        • Huvudutredare:
          • Chelsea Ash
    • Quebec
      • Montreal, Quebec, Kanada, H3H 1P3
        • Rekrytering
        • The Montreal Children's Hospital of the MUHC
        • Kontakt:
        • Huvudutredare:
          • Stephanie Mourad
      • Montreal, Quebec, Kanada, H3T 1C5
        • Rekrytering
        • Centre Hospitalier Universitaire Sainte-Justine
        • Huvudutredare:
          • Monia Marzouki
        • Kontakt:
      • Sherbrooke, Quebec, Kanada, J1H 5N4
        • Rekrytering
        • Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
        • Kontakt:
        • Huvudutredare:
          • Stephanie Vairy
  • Puerto Rico
      • Caguas, Puerto Rico, 00726
        • Aktiv, inte rekryterande
        • HIMA San Pablo Oncologic Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

2 år till 21 år (Barn, Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Patients must be >= 2 years and =< 21 years at the time of enrollment

  • Patients must have a body surface area (BSA) of >= 0.5 m^2 at enrollment

  • Patients must have non-neurofibromatosis type 1 (non-NF1) low-grade glioma (LGG) without a BRAFV600E mutation as confirmed by Rapid Central Pathology and Molecular Screening Reviews performed on APEC14B1 (NCT02402244) Childhood Cancer Data Initiative (CCDI)-MCI, or accepted Clinical Laboratory Improvement Act (CLIA)-certified test and that has not been treated with any modality besides surgery. Note: Patients may be newly-diagnosed OR previously diagnosed, and there is no required time frame between biopsy/surgery and treatment initiation.

    • Patients with residual tumor after resection or progressive tumor after initial diagnosis (with or without surgery) who have not received treatment (chemotherapy and/or radiation) are eligible
    • Patients must have two-dimensional measurable tumor >= 1 cm^2 to be eligible
    • Patients with ependymoma are not eligible

  • Eligible histologies will include all tumors considered low-grade glioma or low-grade astrocytoma (World Health Organization [WHO] grade I and II) by 5th edition WHO classification of central nervous system (CNS) tumors with the exception of subependymal giant cell astrocytoma

  • Patients with metastatic disease or multiple independent primary LGG are eligible

  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 OR a serum creatinine based on age/sex as follows (performed within 7 days prior to enrollment):

    • Age: Maximum Serum Creatinine (mg/dL)
    • 2 to < 6 years: 0.8 mg/dL (male); 0.8 mg/dL (female)
    • 6 to < 10 years: 1 mg/dL (male); 1 mg/dL (female)
    • 10 to < 13 years: 1.2 mg/dL (male); 1.2 mg/dL (female)
    • 13 to < 16 years: 1.5 mg/dL (male); 1.4 mg/dL (female)
    • >= 16 years: 1.7 mg/dL (male); 1.4 mg/dL (female)

  • Total bilirubin =< 1.5 x upper limit of normal (ULN) for age (performed within 7 days prior to enrollment) (children with a diagnosis of Gilbert's syndrome will be allowed on study regardless of their total and indirect [unconjugated] bilirubin levels as long as their direct [conjugated] bilirubin is < 3.1 mg/dL)

  • Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L (performed within 7 days prior to enrollment). For the purpose of this study, the ULN for SGPT is 45 U/L

  • Albumin >= 2 g/dL (performed within 7 days prior to enrollment)

  • Left ventricular ejection fraction (LVEF) >= 53% (or institutional normal; if the LVEF result is given as a range of values, then the upper value of the range will be used) by echocardiogram (performed within 4 weeks prior to enrollment)

  • Corrected QT (QTc) interval =< 450 msec by electrocardiography (EKG) (performed within 4 weeks prior to enrollment)

  • Absolute neutrophil count >= 1,000/uL (unsupported) (performed within 7 days prior to enrollment)

  • Platelets >= 100,000/uL (unsupported) (performed within 7 days prior to enrollment)

  • Hemoglobin >= 8 g/dL (may be supported) (performed within 7 days prior to enrollment)

  • Patients with a known seizure disorder must be stable and must not have experienced a significant increase in seizure frequency within 2 weeks prior to enrollment

  • Patients 2-17 years of age must have a blood pressure that is =< 95th percentile for age, height, and sex at the time of enrollment (with or without the use of anti-hypertensive medications)

  • Patients >= 18 years of age must have a blood pressure =< 130/80 mmHg at the time of enrollment (with or without the use of anti-hypertensive medications)

  • Note for patients of all ages: Adequate blood pressure can be achieved using medication for the treatment of hypertension

  • All patients must have ophthalmology toxicity assessments performed within 8 weeks prior to enrollment

  • For all patients, an MRI of the brain (with orbital cuts for optic pathway tumors) and/or spine (depending on the site(s) of primary disease) with and without contrast must be performed within 8 weeks prior to enrollment

  • Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age

  • Patients must have the ability to swallow whole capsules

  • All patients and/or their parents or legal guardians must sign a written informed consent

  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

  • All patients have signed an appropriate consent form and Health Insurance Portability and Accountability Act (HIPAA) authorization form (if applicable)

  • All patients have been consented and enrolled on APEC14B1 (NCT02402244) Part A for Pre-Enrollment Eligibility Screening for ACNS1833

Exclusion Criteria:

  • Patients must not have received any prior tumor-directed therapy including chemotherapy, radiation therapy, immunotherapy, or bone marrow transplant. Prior surgical intervention (with the exclusion of laser interstitial thermal therapy [LITT]) is permitted

  • Patients with a concurrent malignancy or history of treatment (other than surgery) for another tumor within the last year are ineligible

  • Patients with diffuse intrinsic pontine tumors as seen on MRI (> 2/3 of pons involvement on imaging) are not eligible even if biopsy reveals grade I/II histology

  • Patients may not be receiving any other investigational agents

  • Patients with any serious medical or psychiatric illness/condition, including substance use disorders or ophthalmological conditions, likely in the judgment of the investigator to interfere or limit compliance with study requirements/treatment

  • Patients who, in the opinion of the investigator, are not able to comply with the study procedures are not eligible

  • Female patients who are pregnant are not eligible since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential

  • Lactating females who plan to breastfeed their infants are not eligible

  • Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation and for 1 week after stopping study therapy are not eligible.

    • Note: Women study participants of child-bearing potential must use acceptable contraception during the study and for 1 week (7 days) after the last dose of selumetinib. Men study participants with sexual partners who are pregnant or who are of child-bearing potential must use acceptable contraception during the study and for 1 week (7 days) after the last dose of study agent. Acceptable contraception includes implants, injectables, or oral contraceptives (all combined with barrier methods), some intrauterine devices (IUDs), vasectomy or abstinence

  • Known genetic disorder that increases risk for coronary artery disease. Note: The presence of dyslipidemia in a family with a history of myocardial infarction is not in itself an exclusion unless there is a known genetic disorder documented

  • Symptomatic heart failure

  • New York Health Association (NYHA) class II-IV prior or current cardiomyopathy

  • Severe valvular heart disease

  • History of atrial fibrillation

  • Current or past history of central serous retinopathy

  • Current or past history of retinal vein occlusion or retinal detachment

  • Patients with uncontrolled glaucoma

    • If checking pressure is clinically indicated, patients with intraocular pressure (IOP) > 22 mmHg or ULN adjusted by age are not eligible

  • Supplementation with vitamin E greater than 100% of the daily recommended dose. Any multivitamin containing vitamin E must be stopped prior to study enrollment even if less than 100% of the daily recommended dosing for vitamin E

  • Surgery within 2 weeks prior to enrollment, with the exception of surgical biopsy, placement of a vascular access device or cerebral spinal fluid (CSF) diverting procedure such as endoscopic third ventriculostomy (ETV) and ventriculoperitoneal (VP) shunt.

    • Note: Patients must have healed from any prior surgery

  • Patients who have an uncontrolled infection are not eligible

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Arm I (vincristine sulfate, carboplatin)

INDUCTION: Patients receive vincristine sulfate IV 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. Patients also undergo collection of blood and MRI throughout the trial.

MAINTENANCE: Patients receive vincristine sulfate IV on days 1, 8, and 15, and carboplatin IV over 60 minutes on days 1, 8, 15, and 22 of each cycle. Cycles repeat every 42 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood and MRI throughout the trial.
Läkemedel: Carboplatin

Given IV

Andra namn:
  • Blastocarb
  • Carboplat
  • Carboplatin Hexal
  • Carboplatino
  • Karboplatina
  • Karbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatina
  • Paraplatin
  • Paraplatin AQ
  • Platinwas
  • Ribocarbo
  • JM8
Procedur: Biospecimen Collection

Undergo blood sample collection

Andra namn:
  • Biologisk provsamling
  • Bioprov insamlat
  • Provsamling
  • Provuppsamling
Läkemedel: Vincristine Sulfate

Given IV

Andra namn:
  • Oncovin
  • Kyocristine
  • Leurocristine Sulfate
  • Leurocristine, sulfat
  • Vincasar
  • Vincosid
  • Vincrex
  • Vinkristin, sulfat
Procedur: Magnetic Resonance Imaging

Undergo MRI

Andra namn:
  • MRI
  • Magnetisk resonans
  • Magnetic Resonance Imaging Scan
  • Medicinsk bildbehandling, magnetisk resonans / kärnmagnetisk resonans
  • HERR
  • MR-avbildning
  • MRI-skanning
  • NMR-avbildning
  • NMRI
  • Kärnmagnetisk resonanstomografi
  • Magnetisk resonanstomografi (MRT)
  • sMRI
  • Magnetisk resonanstomografi (förfarande)
  • Strukturell MRI
Övrig: Questionnaire Administration

Ancillary studies
Experimentell: Arm II (selumetinib sulfate)

Patients receive selumetinib sulfate PO BID on days 1-28 of each cycle. Cycles repeat every 28 days for up to 27 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo ECHO at baseline and undergo collection of blood and MRI throughout the trial.
Procedur: Biospecimen Collection

Undergo blood sample collection

Andra namn:
  • Biologisk provsamling
  • Bioprov insamlat
  • Provsamling
  • Provuppsamling
Procedur: Magnetic Resonance Imaging

Undergo MRI

Andra namn:
  • MRI
  • Magnetisk resonans
  • Magnetic Resonance Imaging Scan
  • Medicinsk bildbehandling, magnetisk resonans / kärnmagnetisk resonans
  • HERR
  • MR-avbildning
  • MRI-skanning
  • NMR-avbildning
  • NMRI
  • Kärnmagnetisk resonanstomografi
  • Magnetisk resonanstomografi (MRT)
  • sMRI
  • Magnetisk resonanstomografi (förfarande)
  • Strukturell MRI
Övrig: Questionnaire Administration

Ancillary studies

Procedur: Echocardiography Test

Undergo ECHO

Andra namn:
  • Ekokardiografi
  • EC
Läkemedel: Selumetinib Sulfate

Given PO

Andra namn:
  • AZD-6244 Vätesulfat
  • AZD6244 Vätesulfat
  • Koselugo
  • Selumetinibsulfat

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Event-free survival (EFS)
Tidsram: Up to 10 years from date of randomization

The Kaplan-Meier method will be used to estimate EFS which is defined as the interval from randomization to first occurrence of clinical or radiographic disease progression, disease recurrence, second malignant neoplasm, or death from any cause, or to the date of last follow-up. Estimates with 95% confidence intervals will be reported by treatment arm. The hazard ratio with a confidence interval will also be reported to compare treatment arms based on a Cox proportional hazards model stratified by BRAF status, tumor location and size of residual tumor. Will also provide outcome estimates and their associated confidence intervals by sex, race and ethnicity, as descriptive summaries of outcome.
Up to 10 years from date of randomization

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Radiographic tumor response rate
Tidsram: Up to 10 years

Percentages of patients with responses (complete or partial response) will be reported by treatment arm with 95% confidence intervals. The result of an exact binomial test to test for the difference in response rates between treatment arm will also be reported. Will also provide outcome estimates and their associated confidence intervals by sex, race and ethnicity, as descriptive summaries of outcome.
Up to 10 years
Overall survival (OS)
Tidsram: Up to 10 years from date of randomization

The Kaplan-Meier method will be used to estimate OS by treatment arm, defined as the interval from randomization to death from any cause, or to the date of last follow-up. Estimates with confidence intervals will be reported by treatment arm. Will also provide outcome estimates and their associated confidence intervals by sex, race and ethnicity, as descriptive summaries of outcome.
Up to 10 years from date of randomization
Number of patients who experience an improvement in visual acuity (VA)
Tidsram: After the first 12 months of treatment

Numbers of patients that show improvement in VA after 12 months of treatment will be reported by treatment arm. Patients with at least 1 impaired eye are evaluable. In a patient with a unilateral optic nerve glioma, only the affected eye is considered. In patients with bilateral visual impairment, if VA improves in 1 eye but worsens in the other, the patient will be coded as a treatment failure, whereas if 1 eye improves and the other is at least stable, the patient will be coded as a success.
After the first 12 months of treatment
Change in motor function
Tidsram: After 48 weeks of therapy

Motor function is measured using the Vineland-3 Motor Scale. Only patients with motor function deficits at baseline are included. Magnitudes of change from baseline between the 2 treatment arms and provide a 90% 2-sided confidence interval for this difference.
After 48 weeks of therapy
Change in quality of life (QOL)
Tidsram: Baseline and 9 months after treatment initiation

QOL will be measured using the PedsQL Total Scale Score as measured from the validated PedsQL Generic Module (for children 2-21 years old). Mean differences in the total scale score between 9 months and baseline will be reported by treatment arm. The results of 2-sample t-test comparing differences in the QOL scores between the 2 arms will also be reported. If change scores do not follow normal distributions, non-parametric alternatives may be employed for analysis.
Baseline and 9 months after treatment initiation
Processing speed function
Tidsram: Up to 9 months post-treatment initiation

Measured by Wechsler Processing Speed Index (standard score). Scores at 9 months will be summarized by treatment arm and reported as means (with standard deviations) or medians (with ranges) depending on the data distribution.
Up to 9 months post-treatment initiation
Change in executive function
Tidsram: Baseline and 9-months

Executive function will be measured by the Behavior Rating Inventory of Executive Function, Second Edition BRIEF Cognitive Regulation Index (CRI). Summary statistics for the differences in scores from baseline to 9 months will be reported by treatment arm.
Baseline and 9-months

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in QOL scores over time
Tidsram: At baseline, 9 months, 30 months, and 60 months after treatment initiation

QOL scores for each domain of the PedsQL Generic module will be summarized by timepoint (4 timepoints) and treatment arm. Mean QOL scores will be reported with standard deviations. If scores do not follow normal distributions, medians and ranges will be reported instead.
At baseline, 9 months, 30 months, and 60 months after treatment initiation
Change in neurocognitive functioning scores over time
Tidsram: At baseline, 9 months, 30 months, and 60 months after treatment initiation

Neurocognitive functioning scores for each index/scale of the Behavior Rating Inventory of Executive Function, Second Edition/Preschool Version/Adult will be summarized by timepoint (4 timepoints) and treatment arm. Mean scores will be reported with standard deviations. If scores do not follow normal distributions, medians and ranges will be reported instead.
At baseline, 9 months, 30 months, and 60 months after treatment initiation
EFS by sex
Tidsram: Up to 10 years from date of randomization

Estimates of treatment effect and the corresponding 95% confidence intervals will be provided by sex.
Up to 10 years from date of randomization
EFS by race
Tidsram: Up to 10 years from date of randomization

Estimates of treatment effect and the corresponding 95% confidence intervals will be provided by race.
Up to 10 years from date of randomization
EFS by ethnicity
Tidsram: Up to 10 years from date of randomization

Estimates of treatment effect and the corresponding 95% confidence intervals will be provided by ethnicity.
Up to 10 years from date of randomization
OS by sex
Tidsram: Up to 10 years from date of randomization

Estimates of treatment effect and the corresponding 95% confidence intervals will be provided by sex.
Up to 10 years from date of randomization
OS by race
Tidsram: Up to 10 years from date of randomization

Estimates of treatment effect and the corresponding 95% confidence intervals will be provided by race.
Up to 10 years from date of randomization
OS by ethnicity
Tidsram: Up to 10 years from date of randomization

Estimates of treatment effect and the corresponding 95% confidence intervals will be provided by ethnicity.
Up to 10 years from date of randomization
Neurocognitive outcomes by sex
Tidsram: Up to 10 years from date of randomization

Estimates of treatment effect and the corresponding 95% confidence intervals will be provided by sex.
Up to 10 years from date of randomization
Neurocognitive outcomes by race
Tidsram: Up to 10 years from date of randomization

Estimates of treatment effect and the corresponding 95% confidence intervals will be provided by race.
Up to 10 years from date of randomization
Neurocognitive outcomes by ethnicity
Tidsram: Up to 10 years from date of randomization

Estimates of treatment effect and the corresponding 95% confidence intervals will be provided by ethnicity.
Up to 10 years from date of randomization
QOL by sex
Tidsram: Up to 10 years from date of randomization

Estimates of treatment effect and the corresponding 95% confidence intervals will be provided by sex.
Up to 10 years from date of randomization
QOL by race
Tidsram: Up to 10 years from date of randomization

Estimates of treatment effect and the corresponding 95% confidence intervals will be provided by race.
Up to 10 years from date of randomization
QOL by ethnicity
Tidsram: Up to 10 years from date of randomization

Estimates of treatment effect and the corresponding 95% confidence intervals will be provided by ethnicity.
Up to 10 years from date of randomization

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

National Cancer Institute (NCI)

Utredare

  • Huvudutredare: Peter M de Blank, Children's Oncology Group

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

31 januari 2020

Primärt slutförande (Beräknad)

31 december 2030

Avslutad studie (Beräknad)

31 december 2030

Studieregistreringsdatum

Först inskickad

15 november 2019

Först inskickad som uppfyllde QC-kriterierna

15 november 2019

Första postat (Faktisk)

18 november 2019

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

5 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • NCI-2019-07600
  • U10CA180886 (U.S.S. NIH-anslag/kontrakt)
  • NCI-2019-07600 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
  • ACNS1833 (Annan identifierare: CTEP)
  • ACNS1833 (Annan identifierare: Children's Oncology Group)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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