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Taking people in United StatesPhase 3

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

Key facts

Who runs it
National Cancer Institute (NCI)
Where
Akron, Albany, Ann Arbor, Atlanta, Aurora, Austin, Baltimore, Bangor, Bethesda, Birmingham, Boise, Boston, Buffalo, Burlington, Chapel Hill, Charleston, Charlotte, Chicago, Cincinnati, Cleveland, Columbia, Columbus, Dallas, Danville, Dayton, Des Moines, Detroit, Durham, El Paso, Fargo, Fort Myers, Fort Worth, Gainesville, Grand Rapids, Greenville, Hartford, Hershey, Hollywood, Honolulu, Houston, Indianapolis, Iowa City, Jackson, Jacksonville, Kansas City, Knoxville, Lexington, Little Rock, Loma Linda, Long Beach, Los Angeles, Louisville, Lubbock, Madison, Memphis, Mesa, Miami, Milwaukee, Mineola, Minneapolis, Morgantown, Morristown, Nashville, New Haven, New Hyde Park, New Orleans, New York, Norfolk, Oakland, Oklahoma City, Omaha, Orange, Orlando, Palo Alto, Pensacola, Peoria, Philadelphia, Phoenix, Pittsburgh, Portland, Providence, Richmond, Roanoke, Rochester, Royal Oak, Salt Lake City, San Antonio, San Diego, San Francisco, Scarborough, Seattle, Spokane, Springfield, St Louis, St. Petersburg, Syracuse, Tacoma, Tampa, Valhalla, Washington D.C., Wilmington, and Winston-Salem, United StatesSee the 124 sitesAlso in 2 other countries, 8 sites
Trial code
Status
Recruiting
Phase
Phase 3
People taking part
170 people, planned
Started
31 Jan 2020
Expected to end
31 Dec 2030
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Biospecimen Collection
  • Carboplatin
  • Echocardiography Test
  • Magnetic Resonance Imaging
  • Questionnaire Administration
  • Selumetinib Sulfate
  • Vincristine Sulfate
Record updated
12 November 2026

Who can take part

Age
2 years to 21 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 46 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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 may not be receiving any other investigational agents
  • 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
  • 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
  • New York Health Association (NYHA) class II-IV prior or current cardiomyopathy
  • 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 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
  • 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
  • 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 who have an uncontrolled infection are not eligible
  • 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
  • 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 who, in the opinion of the investigator, are not able to comply with the study procedures are not eligible
  • Lactating females who plan to breastfeed their infants are not eligible

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 2 and 21 years old?

Where in United States

Also in 2 other countries, 8 sites

  • Children's Hospital Medical Center of AkronAkron, United StatesContact: Lauren R. Draper (principal investigator)Taking people
  • Albany Medical CenterAlbany, United StatesContact: Lauren R. Weintraub (principal investigator)Taking people
  • C S Mott Children's HospitalAnn Arbor, United StatesContact: Andrea T. Franson (principal investigator)Taking people
  • Children's Healthcare of Atlanta - Arthur M Blank HospitalAtlanta, United StatesContact: Jason R. Fangusaro (principal investigator)Taking people
  • Children's Hospital ColoradoAurora, United StatesContact: Jean M. Mulcahy Levy (principal investigator)Taking people
  • Dell Children's Medical Center of Central TexasAustin, United StatesContact: Shannon M. Cohn (principal investigator)Taking people
  • Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimore, United StatesContact: Kenneth J. Cohen (principal investigator)Taking people
  • Eastern Maine Medical CenterBangor, United StatesTaking people
  • Walter Reed National Military Medical CenterBethesda, United StatesContact: Kip R. Hartman (principal investigator)Taking people
  • Children's Hospital of AlabamaBirmingham, United StatesContact: Laura K. Metrock (principal investigator)Taking people
  • Saint Luke's Cancer Institute - BoiseBoise, United StatesContact: Martha M. Pacheco (principal investigator)Taking people
  • Dana-Farber Cancer InstituteBoston, United StatesNo longer taking part
  • Massachusetts General Hospital Cancer CenterBoston, United StatesNo longer taking part
  • Roswell Park Cancer InstituteBuffalo, United StatesContact: Matthew J. Barth (principal investigator)Taking people
  • University of Vermont and State Agricultural CollegeBurlington, United StatesContact: Jessica L. Heath (principal investigator)Taking people
  • UNC Lineberger Comprehensive Cancer CenterChapel Hill, United StatesContact: David E. Kram (principal investigator)Taking people
  • Medical University of South CarolinaCharleston, United StatesContact: Jacqueline M. Kraveka (principal investigator)Taking people
  • Carolinas Medical Center/Levine Cancer InstituteCharlotte, United StatesContact: Joel A. Kaplan (principal investigator)Taking people
  • Lurie Children's Hospital-ChicagoChicago, United StatesContact: Angela J. Waanders (principal investigator)Taking people
  • University of Chicago Comprehensive Cancer CenterChicago, United StatesContact: Wendy S. Darlington (principal investigator)Taking people
  • University of IllinoisChicago, United StatesContact: Dipti S. Dighe (principal investigator)Taking people
  • Cincinnati Children's Hospital Medical CenterCincinnati, United StatesContact: Peter M. de Blank (principal investigator)Taking people
  • Rainbow Babies and Childrens HospitalCleveland, United StatesContact: Duncan S. Stearns (principal investigator)Taking people
  • Prisma Health Richland HospitalColumbia, United StatesContact: Stuart L. Cramer (principal investigator)Taking people
  • Nationwide Children's HospitalColumbus, United StatesContact: Mark A. Ranalli (principal investigator)Taking people
  • UT Southwestern/Simmons Cancer Center-DallasDallas, United StatesContact: Daniel C. Bowers (principal investigator)Taking people
  • Geisinger Medical CenterDanville, United StatesContact: Jagadeesh Ramdas (principal investigator)Taking people
  • Dayton Children's HospitalDayton, United StatesContact: Jordan M. Wright (principal investigator)Taking people
  • Blank Children's HospitalDes Moines, United StatesContact: Samantha L. Mallory (principal investigator)Taking people
  • Children's Hospital of MichiganDetroit, United StatesContact: Stephanie A. Toll (principal investigator)Taking people
  • Duke University Medical CenterDurham, United StatesContact: Jessica M. Sun (principal investigator)Taking people
  • El Paso Children's HospitalEl Paso, United StatesContact: Benjamin Carcamo (principal investigator)Taking people
  • Sanford Broadway Medical CenterFargo, United StatesContact: Samuel J. Milanovich (principal investigator)Taking people
  • Golisano Children's Hospital of Southwest FloridaFort Myers, United StatesContact: Emad K. Salman (principal investigator)Taking people
  • Cook Children's Medical CenterFort Worth, United StatesContact: Sibo Zhao (principal investigator)Taking people
  • UF Health Cancer Institute - GainesvilleGainesville, United StatesNo longer taking part
  • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's HospitalGrand Rapids, United StatesContact: Kathleen Y. Butler (principal investigator)Taking people
  • BI-LO Charities Children's Cancer CenterGreenville, United StatesContact: Aniket Saha (principal investigator)Taking people
  • East Carolina UniversityGreenville, United StatesContact: Andrea R. Whitfield (principal investigator)Taking people
  • Connecticut Children's Medical CenterHartford, United StatesContact: Michael S. Isakoff (principal investigator)Taking people
  • Penn State Children's HospitalHershey, United StatesContact: Lisa M. McGregor (principal investigator)Taking people
  • Memorial Regional Hospital/Joe DiMaggio Children's HospitalHollywood, United StatesContact: Iftikhar Hanif (principal investigator)Taking people
  • Kapiolani Medical Center for Women and ChildrenHonolulu, United StatesContact: Wade T. Kyono (principal investigator)Taking people
  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterHouston, United StatesContact: Murali M. Chintagumpala (principal investigator)Taking people
  • UT MD Anderson Cancer CenterHouston, United StatesContact: Najat C. Daw (principal investigator)Taking people
  • Ascension Saint Vincent Indianapolis HospitalIndianapolis, United StatesContact: Jessica F. Goodman (principal investigator)Taking people
  • Riley Hospital for ChildrenIndianapolis, United StatesContact: Sandeep Batra (principal investigator)Taking people
  • University of Iowa/Holden Comprehensive Cancer CenterIowa City, United StatesContact: Andrew P. Groves (principal investigator)Taking people
  • University of Mississippi Medical CenterJackson, United StatesContact: Amanda Strobel (principal investigator)Taking people
  • Nemours Children's Clinic-JacksonvilleJacksonville, United StatesContact: Sridhi Patel (principal investigator)Taking people
  • Children's Mercy Hospitals and ClinicsKansas City, United StatesContact: Keith J. August (principal investigator)Taking people
  • East Tennessee Childrens HospitalKnoxville, United StatesContact: Susan E. Spiller (principal investigator)Taking people
  • University of Kentucky/Markey Cancer CenterLexington, United StatesContact: James T. Badgett (principal investigator)Taking people
  • Arkansas Children's HospitalLittle Rock, United StatesContact: Michael W. Bishop (principal investigator)Taking people
  • Loma Linda University Medical CenterLoma Linda, United StatesContact: Albert Kheradpour (principal investigator)Taking people
  • Miller Children's and Women's Hospital Long BeachLong Beach, United StatesContact: Jacqueline N. Casillas (principal investigator)Taking people
  • Cedars-Sinai Medical CenterLos Angeles, United StatesContact: Fataneh (Fae) Majlessipour (principal investigator)Taking people
  • Children's Hospital Los AngelesLos Angeles, United StatesContact: Nathan J. Robison (principal investigator)Taking people
  • Mattel Children's Hospital UCLALos Angeles, United StatesContact: Satiro N. De Oliveira (principal investigator)Taking people
  • Norton Children's HospitalLouisville, United StatesContact: Michael J. Ferguson (principal investigator)Taking people
  • Covenant Children's HospitalLubbock, United StatesContact: Kishor M. Bhende (principal investigator)Taking people
  • UMC Cancer Center / UMC Health SystemLubbock, United StatesContact: Erin K. Barr (principal investigator)Taking people
  • University of Wisconsin Carbone Cancer Center - University HospitalMadison, United StatesContact: Nicholas J. Pytel (principal investigator)Taking people
  • Saint Jude Children's Research HospitalMemphis, United StatesContact: Anna Vinitsky (principal investigator)Taking people
  • Banner Children's at DesertMesa, United StatesContact: Joseph C. Torkildson (principal investigator)Taking people
  • Nicklaus Children's HospitalMiami, United StatesContact: Ziad A. Khatib (principal investigator)Taking people
  • University of Miami Miller School of Medicine-Sylvester Cancer CenterMiami, United StatesNo longer taking part
  • Children's Hospital of WisconsinMilwaukee, United StatesContact: Sarah Rumler (principal investigator)Taking people
  • NYU Langone Hospital - Long IslandMineola, United StatesContact: Chana L. Glasser (principal investigator)Taking people
  • Children's Hospitals and Clinics of Minnesota - MinneapolisMinneapolis, United StatesContact: Michael K. Richards (principal investigator)Taking people
  • University of Minnesota/Masonic Cancer CenterMinneapolis, United StatesContact: Clay M. Hoerig (principal investigator)Taking people
  • West Virginia University HealthcareMorgantown, United StatesContact: Ashley E. Meyer (principal investigator)Taking people
  • Morristown Medical CenterMorristown, United StatesContact: Kathryn L. Laurie (principal investigator)Taking people
  • Vanderbilt University/Ingram Cancer CenterNashville, United StatesContact: Devang J. Pastakia (principal investigator)Taking people
  • Yale UniversityNew Haven, United StatesContact: Asher M. Marks (principal investigator)Taking people
  • The Steven and Alexandra Cohen Children's Medical Center of New YorkNew Hyde Park, United StatesContact: Mark P. Atlas (principal investigator)Taking people
  • Children's Hospital New OrleansNew Orleans, United StatesContact: Maria C. Velez-Yanguas (principal investigator)Taking people
  • Laura and Isaac Perlmutter Cancer Center at NYU LangoneNew York, United StatesContact: Elizabeth A. Raetz (principal investigator)Taking people
  • Memorial Sloan-Kettering Cancer CenterNew York, United StatesContact: Sameer Farouk Sait (principal investigator)Taking people
  • Children's Hospital of The King's DaughtersNorfolk, United StatesContact: Melissa S. Mark (principal investigator)Taking people
  • Kaiser Permanente-OaklandOakland, United StatesContact: Aarati V. Rao (principal investigator)Taking people
  • University of Oklahoma Health Sciences CenterOklahoma City, United StatesContact: Rene Y. McNall-Knapp (principal investigator)Taking people
  • Children's Hospital and Medical Center of OmahaOmaha, United StatesContact: Jill C. Beck (principal investigator)Taking people
  • University of Nebraska Medical CenterOmaha, United StatesContact: Jill C. Beck (principal investigator)Taking people
  • Children's Hospital of Orange CountyOrange, United StatesContact: Elyssa M. Rubin (principal investigator)Taking people
  • AdventHealth OrlandoOrlando, United StatesContact: Fouad M. Hajjar (principal investigator)Taking people
  • Arnold Palmer Hospital for ChildrenOrlando, United StatesContact: Zhongbo Hu (principal investigator)Taking people
  • Nemours Children's HospitalOrlando, United StatesContact: Sridhi Patel (principal investigator)Taking people
  • Lucile Packard Children's Hospital Stanford UniversityPalo Alto, United StatesContact: Jay Michael S. Balagtas (principal investigator)Taking people
  • Nemours Children's Clinic - PensacolaPensacola, United StatesContact: Jeffrey H. Schwartz (principal investigator)Taking people
  • Sacred Heart HospitalPensacola, United StatesNo longer taking part
  • OSF Children's Hospital of IllinoisPeoria, United StatesContact: Prerna Kumar (principal investigator)Taking people
  • Children's Hospital of PhiladelphiaPhiladelphia, United StatesContact: Michael J. Fisher (principal investigator)Taking people
  • Saint Christopher's Hospital for ChildrenPhiladelphia, United StatesContact: Gregory E. Halligan (principal investigator)Taking people
  • Phoenix Childrens HospitalPhoenix, United StatesContact: Kazuhiro Sabet (principal investigator)Taking people
  • Children's Hospital of Pittsburgh of UPMCPittsburgh, United StatesContact: James T. Felker (principal investigator)Taking people
  • Oregon Health and Science UniversityPortland, United StatesContact: Neha J. Patel (principal investigator)Taking people
  • Rhode Island HospitalProvidence, United StatesContact: Bradley DeNardo (principal investigator)Taking people
  • VCU Massey Comprehensive Cancer CenterRichmond, United StatesContact: Christopher Park (principal investigator)Taking people
  • Carilion Children'sRoanoke, United StatesContact: Erwood G. Edwards (principal investigator)Taking people
  • Mayo Clinic in RochesterRochester, United StatesContact: Joseph Z. Wilson (principal investigator)Taking people
  • University of RochesterRochester, United StatesNo longer taking part
  • Corewell Health Children'sRoyal Oak, United StatesNo longer taking part
  • Primary Children's HospitalSalt Lake City, United StatesContact: Priya Chan (principal investigator)Taking people
  • Children's Hospital of San AntonioSan Antonio, United StatesContact: Julie Voeller (principal investigator)Taking people
  • Methodist Children's Hospital of South TexasSan Antonio, United StatesContact: Jose M. Esquilin (principal investigator)Taking people
  • University of Texas Health Science Center at San AntonioSan Antonio, United StatesContact: Shafqat Shah (principal investigator)Taking people
  • Rady Children's Hospital - San DiegoSan Diego, United StatesContact: William D. Roberts (principal investigator)Taking people
  • UCSF Medical Center-Mission BaySan Francisco, United StatesContact: Alyssa T. Reddy (principal investigator)Taking people
  • Maine Children's Cancer ProgramScarborough, United StatesContact: Stanley Chaleff (principal investigator)Taking people
  • Seattle Children's HospitalSeattle, United StatesContact: Sarah E. Leary (principal investigator)Taking people
  • Providence Sacred Heart Medical Center and Children's HospitalSpokane, United StatesContact: Judy L. Felgenhauer (principal investigator)Taking people
  • Southern Illinois University School of MedicineSpringfield, United StatesContact: Gregory P. Brandt (principal investigator)Taking people
  • Cardinal Glennon Children's Medical CenterSt Louis, United StatesContact: William S. Ferguson (principal investigator)Taking people
  • Washington University School of MedicineSt Louis, United StatesContact: Andrew S. Cluster (principal investigator)Taking people
  • Johns Hopkins All Children's HospitalSt. Petersburg, United StatesContact: Stacie L. Stapleton (principal investigator)Taking people
  • State University of New York Upstate Medical UniversitySyracuse, United StatesContact: Melanie A. Comito (principal investigator)Taking people
  • Madigan Army Medical CenterTacoma, United StatesContact: Melissa A. Forouhar (principal investigator)Taking people
  • Mary Bridge Children's Hospital and Health CenterTacoma, United StatesContact: Robert G. Irwin (principal investigator)Taking people
  • Saint Joseph's Hospital/Children's Hospital-TampaTampa, United StatesContact: Don E. Eslin (principal investigator)Taking people
  • New York Medical CollegeValhalla, United StatesContact: Andrew J. Bellantoni (principal investigator)Taking people
  • Children's National Medical CenterWashington D.C., United StatesContact: Jeffrey S. Dome (principal investigator)Taking people
  • Alfred I duPont Hospital for ChildrenWilmington, United StatesContact: Sridhi Patel (principal investigator)Taking people
  • Wake Forest University Health SciencesWinston-Salem, United StatesContact: Sarah Supples (principal investigator)Taking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Arm I (vincristine sulfate, carboplatin)Existing treatment, for comparison

    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.

    Treatment: Biospecimen Collection, Carboplatin, Magnetic Resonance Imaging, Questionnaire Administration, and Vincristine Sulfate

  • Arm II (selumetinib sulfate)Treatment being tested

    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.

    Treatment: Biospecimen Collection, Echocardiography Test, Magnetic Resonance Imaging, Questionnaire Administration, and Selumetinib Sulfate

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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)
Fit questions
Built from NCT04166409, who can take part
Record updated
12 November 2026