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

Recruitment Status
ACTIVE, NOT RECRUITING
(See Contacts and Locations)Verified January 2026 by National Cancer Institute (NCI)
Sponsor
National Cancer Institute (NCI)
Information Provided by (Responsible Party)
National Cancer Institute (NCI)
Clinicaltrials.gov Identifier
NCT03871257
Other Study ID Numbers:
NCI-2019-01396
First Submitted
March 10, 2019
First Posted
March 11, 2019
Last Update Posted
April 12, 2026
Last Verified
January 2026

ClinicalTrials.gov processed this data on April 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

PRIMARY OBJECTIVES:

I. To determine whether the efficacy of treatment with selumetinib sulfate (selumetinib) as measured by event-free survival (EFS) is non-inferior to treatment with carboplatin/vincristine sulfate (vincristine) (CV) in previously untreated neurofibromatosis type 1 (NF1)-associated low-grade glioma (LGG).

II. To determine whether visual acuity (VA) using Teller acuity cards (TAC), in patients with NF1-associated LGG within the optic pathway, is better in those treated with selumetinib compared to CV.

SECONDARY OBJECTIVES:

I. To estimate tumor response rates and overall survival (OS) in each treatment regimen in previously untreated NF1-associated LGG.

II. To evaluate VA outcomes utilizing HOTV letter acuity testing in previously untreated NF1-associated LGG within the optic pathway in patients who are old enough to perform visual acuity testing utilizing HOTV (a recognition acuity measure).

III. To describe the improvement in motor function as measured by the Vineland scale in patients with previously untreated NF1-associated LGG that have documented motor deficits at enrollment.

IV. To prospectively evaluate and compare the quality of life among patients treated with selumetinib or CV.

V. To prospectively evaluate and compare the cognitive, social, emotional, and behavioral functioning of patients with NF1-associated LGG treated with either selumetinib or CV.

EXPLORATORY OBJECTIVES:

I. To evaluate optical coherence tomography (OCT) measures of retinal axon and ganglion cell thickness as a marker of treatment response in previously untreated NF1-associated LGG within the optic pathway.

II. To compare novel, semi-automated volumetric magnetic resonance imaging (MRI) measures to traditional measurements of treatment response (bi-dimensional MRI measurements) in NF1-associated optic pathway tumors.

III. To obtain paired blood and tumor tissue to be banked for future NF1-LGG biology studies involving comprehensive molecular analysis, including but not limited to whole exome and ribonucleic acid (RNA) sequencing.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I:

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

MAINTENANCE: Patients receive carboplatin IV over 60 minutes on days 1, 8, 15, and 22 of each cycle and vincristine IV on days 1, 8, and 15 of each cycle. Cycles repeat every 6 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI throughout the trial.

ARM II: Patients receive selumetinib sulfate orally (PO) twice daily (BID) on days 1-28 of each cycle. Treatment is continuous and cycles repeat every 28 days for 27 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI throughout the trial.

After completion of study treatment, patients are followed up with MRIs and physical exams every 3 months for 1 year, every 6 months for 2 years, and then once yearly for up to 10 years.

Condition or DiseaseIntervention/Treatment
Low Grade GliomaNeurofibromatosis Type 1Visual Pathway Glioma
Drug: CarboplatinProcedure: Magnetic Resonance Imaging

Study Design

Study TypeInterventional
Actual Enrollment165 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA Phase 3 Randomized Study of Selumetinib Versus Carboplatin/Vincristine in Newly Diagnosed or Previously Untreated Neurofibromatosis Type 1 (NF1) Associated Low-Grade Glioma (LGG)
Study Start DateJanuary 14, 2020
Actual Primary Completion Date1yr 7mos from now
Actual Study Completion Date1yr 7mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Arm I (carboplatin, vincristine)
INDUCTION: Patients receive carboplatin IV over 60 minutes on days 1, 8, 15, 22, 43, 50, 57, and 64 and vincristine IV or IV push over 1 minute on days 1, 8, 15, 22, 29, 36, 43, 50, 57, and 64 in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI throughout the trial. MAINTENANCE: Patients receive carboplatin IV over 60 minutes on days 1, 8, 15, and 22 of each cycle and vincristine IV or IV push over 1 minute on days 1, 8, and 15 of each cycle. Cycles repeat every 6 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI throughout the trial.
Drug: Carboplatin
Given IV
Arm II (selumetinib sulfate)
Patients receive selumetinib sulfate PO BID on days 1-28 of each cycle. Treatment is continuous and cycles repeat every 28 days for 27 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI throughout the trial.
Procedure: Magnetic Resonance Imaging
Undergo MRI

Outcome Measures

Primary Outcome Measures
  1. Event-free survival (EFS)
    EFS is defined as time from randomization to the first occurrence of any of the following events: clinical or radiographic disease progression, disease recurrence, second malignant neoplasm, or death from any cause. Patients who are event-free will be censored at the time of last follow-up. Will estimate the hazard ratio based on a stratified Cox proportional hazards model and use Kaplan Meier (KM) methods to visualize and summarize the data.
  2. Number of participants with visual acuity (VA) improvement per arm
    VA will be assessed using Teller acuity cards (TAC). A significant improvement in VA will be defined as a decrease of \>= 0.2 logMAR (corrected for age) from baseline (pre-treatment baseline) to end of about 12 months of treatment. The primary analysis will be based on per subject outcome (rather than per eye).
Secondary Outcome Measures
  1. Radiographic tumor response rate
    Tumors will be classified into complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD). Radiologic response rates will be summarized per arm and be tested for a difference between the two arms using an exact binomial test.
  2. Overall survival (OS)
    OS is defined as the time from randomization until death from any cause or till the time of last follow-up for patients who are alive at the time of analysis. Will use the KM methods, log-rank tests, and Cox proportional hazards models to determine whether there is a difference in OS between the two arms.
  3. Change in VA using HOTV letter acuity testing
    HOTV is a recognition acuity measure. It will be conducted on patients who are developmentally able to perform this testing.
  4. Change in motor function
    The Vineland-3 Motor Scale from the Comprehensive Parent Rating Form will be used to assess motor deficits. Change in Vineland motor scale from baseline to about 12 months of treatment will be compared between two treatment arms.
  5. Change in quality of life (QOL)
    Will be measured by Pain and Hurt subscale score. QOL will be assessed by Pediatric Quality of Life (PedsQL) Generic and Brain Tumor modules. Analysis will be based on a 2-sample t-test comparing change in Pain and Hurt subscale score from baseline to 12 months for the two arms.
  6. Change in quality of life (QOL)
    Will be measured by Movement and Balance subscale score. QOL will be assessed by Pediatric Quality of Life (PedsQL) Generic and Brain Tumor modules. Analysis will be based on a 2-sample t-test comparing change in Movement and Balance subscale score from baseline to 12 months for the two arms.
  7. Change in executive function
    Will be measured by BRIEF Cognitive Regulation Index (CRI). Executive function will be measured by age-appropriate Behavior Rating Inventory of Executive Function (BRIEF) questionnaire. Analysis will be based on a 2-sample t-test comparing change in the designated score from baseline to 24 months for the two arms.
  8. Change in neurocognitive function
    Will be measured by Cogstate composite score. Neurocognitive function will be measured by a computerized battery (Cogstate) testing. Analysis will be based on a 2-sample t-test comparing change in Cogstate composite score from baseline to 24 months for the two arms.

Eligibility Criteria

Ages Eligible for Study(Child, Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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 neurofibromatosis type 1 (NF1) based on clinical criteria and/or germline genetic testing
Patients must be newly diagnosed or have previously diagnosed NF-1 associated LGG that has not been treated with any modality other than surgery
For patients with optic pathway gliomas (OPGs):
Newly-diagnosed patients with OPG are eligible if there are neurologic symptoms (including visual dysfunction, as defined below) or other exam findings associated with the tumor
Previously-diagnosed patients with OPG are eligible if they have new or worsening neurologic symptoms (including visual dysfunction, as defined below) or have tumor growth
For both newly-diagnosed and previously-diagnosed OPG, the patient may be eligible, irrespective of whether there has been tumor growth or other neurological symptoms or worsening, if they meet at least one of the following visual criteria:
Visual worsening, defined as worsening of visual acuity (VA) or visual fields (VF) documented within the past year (by examination or history); OR
Significant visual dysfunction (defined as VA worse than normal for age by 0.6 logMAR \[20/80, 6/24, or 2.5/10\] or more in one or both eyes)
For patients with LGG in other locations (i.e., not OPGs):
Newly-diagnosed patients with LGG are eligible if there are neurologic symptoms or other exam findings associated with the tumor
NOTE: Newly-diagnosed patients with LGG without associated neurologic symptoms or exam findings are not eligible
Previously-diagnosed patients with LGG are eligible if they have new or worsening neurologic symptoms or have tumor growth
Although not required, if a biopsy/tumor resection is performed, eligible histologies will include all tumors considered LGG 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 must have two-dimensional measurable tumor \>= 1 cm\^2
Patients with metastatic disease or multiple independent primary LGGs are allowed on study
Creatinine clearance or radioisotope glomerular filtration Rate (GFR) \>= 70 mL/min/1.73 m\^2 OR a serum creatinine based on age/sex (within 7 days prior to enrollment) as follows:
Age; maximum serum creatinine (mg/dL)
2 to \< 6 years; 0.8 (male) and 0.8 (female)
6 to \< 10 years; 1 (male) and 1 (female)
10 to \< 13 years; 1.2 (male) and 1.2 (female)
13 to \< 16 years; 1.5 (male) and 1.4 (female)
\>= 16 years; 1.7 (male) and 1.4 (female)
Total bilirubin =\< 1.5 x upper limit of normal (ULN) for age (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 glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 3 x upper limit of normal (ULN) = 135 U/L (within 7 days prior to enrollment). For the purpose of this study, the ULN for SGPT is 45 U/L
Albumin \>= 2 g/dL (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 (within 4 weeks prior to enrollment)
Corrected QT (QTc) interval =\< 450 msec by electrocardiography (EKG) (within 4 weeks prior to enrollment)
Absolute neutrophil count \>= 1,000/uL (unsupported) (within 7 days prior to enrollment)
Platelets \>= 100,000/uL (unsupported) (within 7 days prior to enrollment)
Hemoglobin \>= 8 g/dL (may be supported) (within 7 days prior to enrollment)
Patients with a known seizure disorder should be stable and should have not 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. Patients \>= 18 years of age must have a blood pressure =\< 130/80 mmHg at the time of enrollment (with or without the use of antihypertensive medications).
Note: 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
For patients who undergo a surgery on the target tumor (not required), a pre- and post-operative\
MRI of the brain (with orbital cuts for optic pathway tumors) or spine (depending on the site(s) of primary disease) with and without contrast must also be performed. The post-operative MRI must be performed within 4 weeks prior to enrollment. If only a biopsy is performed, a post-operative MRI is not required and the pre-operative (op) MRI within 8 weeks of enrollment will be used as the baseline scan
The post-operative MRIs should be performed ideally within 48 hours after surgery if possible
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
Patients must have receptive and expressive language skills in English, Spanish or French to complete the quality of life (QOL) and neurocognitive assessments
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.
Exclusion Criteria
Patients must not have received any prior tumor-directed therapy including chemotherapy, radiation therapy, immunotherapy, or bone marrow transplant. Prior surgical intervention 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
Patients with any serious medical or psychiatric illness/ condition, including substance use disorders likely in the judgement of the investigator to interfere or limit compliance with study requirements/treatment are not eligible
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 12 weeks after stopping study therapy are not eligible
Note: Women of child-bearing potential and males with sexual partners who are pregnant or who could become pregnant (i.e., women of child-bearing potential) should use effective methods of contraception for the duration of the study and for 12 weeks after stopping study therapy to avoid pregnancy and/or potential adverse effects on the developing embryo
Cardiac conditions:
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 Heart Association (NYHA) class II-IV prior or current cardiomyopathy
Severe valvular heart disease
History of atrial fibrillation
Ophthalmologic conditions:
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
Ophthalmological findings secondary to long-standing optic pathway glioma (such as visual loss, optic nerve pallor, or strabismus) or longstanding orbito-temporal plexiform neurofibroma (PN), such as visual loss, strabismus) will NOT be considered a significant abnormality for the purposes of the study
Treatments and/or medications patient is receiving that would make her/him ineligible, such as:
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 placement for vascular access or cerebrospinal fluid (CSF) diverting procedures such as endoscopic third ventriculostomy (ETV) and ventriculo-peritoneal (VP) shunt.
Note: Patients must have healed from any prior surgery prior to enrollment
Patients who have an uncontrolled infection are not eligible

Contacts and Locations

Sponsors and CollaboratorsNational Cancer Institute (NCI)
Locations
Children's Hospital of Alabama | Birmingham Alabama, United States, 35233Banner Children's at Desert | Mesa Arizona, United States, 85202Phoenix Childrens Hospital | Phoenix Arizona, United States, 85016Arkansas Children's Hospital | Little Rock Arkansas, United States, 72202-3591Loma Linda University Medical Center | Loma Linda California, United States, 92354Children's Hospital Los Angeles | Los Angeles California, United States, 90027Kaiser Permanente-Oakland | Oakland California, United States, 94611Children's Hospital of Orange County | Orange California, United States, 92868Lucile Packard Children's Hospital Stanford University | Palo Alto California, United States, 94304Rady Children's Hospital - San Diego | San Diego California, United States, 92123Naval Medical Center -San Diego | San Diego California, United States, 92134UCSF Medical Center-Mission Bay | San Francisco California, United States, 94158Children's Hospital Colorado | Aurora Colorado, United States, 80045Connecticut Children's Medical Center | Hartford Connecticut, United States, 06106Yale University | New Haven Connecticut, United States, 06520Alfred I duPont Hospital for Children | Wilmington Delaware, United States, 19803Children's National Medical Center | Washington D.C. District of Columbia, United States, 20010Golisano Children's Hospital of Southwest Florida | Fort Myers Florida, United States, 33908UF Health Cancer Institute - Gainesville | Gainesville Florida, United States, 32610Memorial Regional Hospital/Joe DiMaggio Children's Hospital | Hollywood Florida, United States, 33021Nemours Children's Clinic-Jacksonville | Jacksonville Florida, United States, 32207Nicklaus Children's Hospital | Miami Florida, United States, 33155AdventHealth Orlando | Orlando Florida, United States, 32803Arnold Palmer Hospital for Children | Orlando Florida, United States, 32806Nemours Children's Hospital | Orlando Florida, United States, 32827Sacred Heart Hospital | Pensacola Florida, United States, 32504Johns Hopkins All Children's Hospital | St. Petersburg Florida, United States, 33701Saint Joseph's Hospital/Children's Hospital-Tampa | Tampa Florida, United States, 33607Children's Healthcare of Atlanta - Arthur M Blank Hospital | Atlanta Georgia, United States, 30329Kapiolani Medical Center for Women and Children | Honolulu Hawaii, United States, 96826Saint Luke's Cancer Institute - Boise | Boise Idaho, United States, 83712Lurie Children's Hospital-Chicago | Chicago Illinois, United States, 60611University of Illinois | Chicago Illinois, United States, 60612University of Chicago Comprehensive Cancer Center | Chicago Illinois, United States, 60637Southern Illinois University School of Medicine | Springfield Illinois, United States, 62702Riley Hospital for Children | Indianapolis Indiana, United States, 46202Ascension Saint Vincent Indianapolis Hospital | Indianapolis Indiana, United States, 46260Blank Children's Hospital | Des Moines Iowa, United States, 50309University of Iowa/Holden Comprehensive Cancer Center | Iowa City Iowa, United States, 52242University of Kentucky/Markey Cancer Center | Lexington Kentucky, United States, 40536Norton Children's Hospital | Louisville Kentucky, United States, 40202Children's Hospital New Orleans | New Orleans Louisiana, United States, 70118Ochsner Medical Center Jefferson | New Orleans Louisiana, United States, 70121Eastern Maine Medical Center | Bangor Maine, United States, 04401Maine Children's Cancer Program | Scarborough Maine, United States, 04074Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore Maryland, United States, 21287Walter Reed National Military Medical Center | Bethesda Maryland, United States, 20889-5600Massachusetts General Hospital Cancer Center | Boston Massachusetts, United States, 02114Dana-Farber Cancer Institute | Boston Massachusetts, United States, 02215C S Mott Children's Hospital | Ann Arbor Michigan, United States, 48109Children's Hospital of Michigan | Detroit Michigan, United States, 48201Wayne State University/Karmanos Cancer Institute | Detroit Michigan, United States, 48201Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital | Grand Rapids Michigan, United States, 49503Corewell Health Children's | Royal Oak Michigan, United States, 48073Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis Minnesota, United States, 55404University of Minnesota/Masonic Cancer Center | Minneapolis Minnesota, United States, 55455Mayo Clinic in Rochester | Rochester Minnesota, United States, 55905University of Mississippi Medical Center | Jackson Mississippi, United States, 39216University of Missouri Children's Hospital | Columbia Missouri, United States, 65212Children's Mercy Hospitals and Clinics | Kansas City Missouri, United States, 64108Cardinal Glennon Children's Medical Center | St Louis Missouri, United States, 63104Washington University School of Medicine | St Louis Missouri, United States, 63110Children's Hospital and Medical Center of Omaha | Omaha Nebraska, United States, 68114University of Nebraska Medical Center | Omaha Nebraska, United States, 68198Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center | Lebanon New Hampshire, United States, 03756Morristown Medical Center | Morristown New Jersey, United States, 07960Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital | New Brunswick New Jersey, United States, 08903Presbyterian Hospital | Albuquerque New Mexico, United States, 87106University of New Mexico Cancer Center | Albuquerque New Mexico, United States, 87106Albany Medical Center | Albany New York, United States, 12208Roswell Park Cancer Institute | Buffalo New York, United States, 14263The Steven and Alexandra Cohen Children's Medical Center of New York | New Hyde Park New York, United States, 11040Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York New York, United States, 10016Memorial Sloan Kettering Cancer Center | New York New York, United States, 10065University of Rochester | Rochester New York, United States, 14642State University of New York Upstate Medical University | Syracuse New York, United States, 13210New York Medical College | Valhalla New York, United States, 10595UNC Lineberger Comprehensive Cancer Center | Chapel Hill North Carolina, United States, 27599Carolinas Medical Center/Levine Cancer Institute | Charlotte North Carolina, United States, 28203Duke University Medical Center | Durham North Carolina, United States, 27710East Carolina University | Greenville North Carolina, United States, 27834Wake Forest University Health Sciences | Winston-Salem North Carolina, United States, 27157Sanford Broadway Medical Center | Fargo North Dakota, United States, 58122Children's Hospital Medical Center of Akron | Akron Ohio, United States, 44308Cincinnati Children's Hospital Medical Center | Cincinnati Ohio, United States, 45229Rainbow Babies and Childrens Hospital | Cleveland Ohio, United States, 44106Nationwide Children's Hospital | Columbus Ohio, United States, 43205Dayton Children's Hospital | Dayton Ohio, United States, 45404University of Oklahoma Health Sciences Center | Oklahoma City Oklahoma, United States, 73104Legacy Emanuel Children's Hospital | Portland Oregon, United States, 97227Oregon Health and Science University | Portland Oregon, United States, 97239Geisinger Medical Center | Danville Pennsylvania, United States, 17822Penn State Children's Hospital | Hershey Pennsylvania, United States, 17033Children's Hospital of Philadelphia | Philadelphia Pennsylvania, United States, 19104Saint Christopher's Hospital for Children | Philadelphia Pennsylvania, United States, 19134Children's Hospital of Pittsburgh of UPMC | Pittsburgh Pennsylvania, United States, 15224Rhode Island Hospital | Providence Rhode Island, United States, 02903Medical University of South Carolina | Charleston South Carolina, United States, 29425Prisma Health Richland Hospital | Columbia South Carolina, United States, 29203BI-LO Charities Children's Cancer Center | Greenville South Carolina, United States, 29605East Tennessee Childrens Hospital | Knoxville Tennessee, United States, 37916Saint Jude Children's Research Hospital | Memphis Tennessee, United States, 38105Vanderbilt University/Ingram Cancer Center | Nashville Tennessee, United States, 37232Dell Children's Medical Center of Central Texas | Austin Texas, United States, 78723UT Southwestern/Simmons Cancer Center-Dallas | Dallas Texas, United States, 75390El Paso Children's Hospital | El Paso Texas, United States, 79905Cook Children's Medical Center | Fort Worth Texas, United States, 76104Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center | Houston Texas, United States, 77030M D Anderson Cancer Center | Houston Texas, United States, 77030Covenant Children's Hospital | Lubbock Texas, United States, 79410UMC Cancer Center / UMC Health System | Lubbock Texas, United States, 79415Children's Hospital of San Antonio | San Antonio Texas, United States, 78207Methodist Children's Hospital of South Texas | San Antonio Texas, United States, 78229University of Texas Health Science Center at San Antonio | San Antonio Texas, United States, 78229Primary Children's Hospital | Salt Lake City Utah, United States, 84113University of Vermont and State Agricultural College | Burlington Vermont, United States, 05405Children's Hospital of The King's Daughters | Norfolk Virginia, United States, 23507VCU Massey Comprehensive Cancer Center | Richmond Virginia, United States, 23298Carilion Children's | Roanoke Virginia, United States, 24014Seattle Children's Hospital | Seattle Washington, United States, 98105Providence Sacred Heart Medical Center and Children's Hospital | Spokane Washington, United States, 99204Mary Bridge Children's Hospital and Health Center | Tacoma Washington, United States, 98405Madigan Army Medical Center | Tacoma Washington, United States, 98431University of Wisconsin Carbone Cancer Center - University Hospital | Madison Wisconsin, United States, 53792Children's Hospital of Wisconsin | Milwaukee Wisconsin, United States, 53226British Columbia Children's Hospital | Vancouver British Columbia, Canada, V6H 3V4IWK Health Centre | Halifax Nova Scotia, Canada, B3K 6R8Hospital for Sick Children | Toronto Ontario, Canada, M5G 1X8The Montreal Children's Hospital of the MUHC | Montreal Quebec, Canada, H3H 1P3Centre Hospitalier Universitaire Sainte-Justine | Montreal Quebec, Canada, H3T 1C5Centre Hospitalier Universitaire de Sherbrooke-Fleurimont | Sherbrooke Quebec, Canada, J1H 5N4HIMA San Pablo Oncologic Hospital | Caguas , Puerto Rico, 00726
Investigators
Principal Investigator: Jason R Fangusaro, Children's Oncology Group
Study Documents (Full Text)
Documents provided by National Cancer Institute (NCI): Informed Consent Form  May 14, 2025