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

Primary Purpose

Low Grade Astrocytoma, Low Grade Glioma, Metastatic Low Grade Astrocytoma

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Biospecimen Collection
Carboplatin
Magnetic Resonance Imaging
Quality-of-Life Assessment
Questionnaire Administration
Selumetinib Sulfate
Vincristine Sulfate
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Grade Astrocytoma

Eligibility Criteria

2 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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) 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
  • 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/gender 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 should be stable and should 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 gender at the time of enrollment (with or without the use of anti-hypertensive medications)
  • All patients must have ophthalmology toxicity assessments performed within 4 weeks prior to 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 anti-hypertensive medications)
  • Note for patients of all ages: Adequate blood pressure can be achieved using medication for the treatment of hypertension
  • For all patients, a magnetic resonance imaging (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 4 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 have signed an appropriate consent form and Health Insurance Portability and Accountability Act (HIPAA) authorization form (if applicable)
  • All patients and/or their parents or legal guardians must sign a written informed consent
  • All patients have been consented and enrolled on APEC14B1 (NCT02402244) followed by enrollment on the ACNS1833 Pre-Enrollment Eligibility Screening (Step 0) on the same day to complete the Rapid Central Review
  • 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 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 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
  • 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

Sites / Locations

  • Children's Hospital of AlabamaRecruiting
  • Banner Children's at DesertRecruiting
  • Phoenix Childrens HospitalRecruiting
  • Arkansas Children's HospitalRecruiting
  • Loma Linda University Medical CenterRecruiting
  • Children's Hospital Los AngelesRecruiting
  • Cedars Sinai Medical CenterRecruiting
  • Mattel Children's Hospital UCLARecruiting
  • Kaiser Permanente-OaklandRecruiting
  • Children's Hospital of Orange CountyRecruiting
  • Lucile Packard Children's Hospital Stanford UniversityRecruiting
  • Rady Children's Hospital - San DiegoRecruiting
  • UCSF Medical Center-Mission BayRecruiting
  • Children's Hospital ColoradoRecruiting
  • Connecticut Children's Medical CenterRecruiting
  • Yale UniversityRecruiting
  • Alfred I duPont Hospital for ChildrenRecruiting
  • Children's National Medical CenterRecruiting
  • University of Florida Health Science Center - GainesvilleRecruiting
  • Memorial Regional Hospital/Joe DiMaggio Children's HospitalRecruiting
  • Nemours Children's Clinic-JacksonvilleRecruiting
  • University of Miami Miller School of Medicine-Sylvester Cancer Center
  • Nicklaus Children's HospitalRecruiting
  • AdventHealth OrlandoRecruiting
  • Arnold Palmer Hospital for ChildrenRecruiting
  • Nemours Children's HospitalRecruiting
  • Sacred Heart HospitalRecruiting
  • Johns Hopkins All Children's HospitalRecruiting
  • Children's Healthcare of Atlanta - EglestonRecruiting
  • Kapiolani Medical Center for Women and ChildrenRecruiting
  • Saint Luke's Cancer Institute - BoiseRecruiting
  • Lurie Children's Hospital-ChicagoRecruiting
  • University of IllinoisRecruiting
  • University of Chicago Comprehensive Cancer CenterRecruiting
  • Southern Illinois University School of MedicineRecruiting
  • Riley Hospital for ChildrenRecruiting
  • Ascension Saint Vincent Indianapolis HospitalRecruiting
  • Blank Children's HospitalRecruiting
  • University of Iowa/Holden Comprehensive Cancer CenterRecruiting
  • University of Kentucky/Markey Cancer CenterRecruiting
  • Norton Children's HospitalRecruiting
  • Children's Hospital New OrleansRecruiting
  • Eastern Maine Medical CenterRecruiting
  • Maine Children's Cancer ProgramRecruiting
  • Johns Hopkins University/Sidney Kimmel Cancer CenterRecruiting
  • Walter Reed National Military Medical CenterRecruiting
  • Massachusetts General Hospital Cancer CenterRecruiting
  • Dana-Farber Cancer InstituteRecruiting
  • C S Mott Children's HospitalRecruiting
  • Children's Hospital of MichiganRecruiting
  • Helen DeVos Children's Hospital at Spectrum HealthRecruiting
  • Beaumont Children's Hospital-Royal OakRecruiting
  • Children's Hospitals and Clinics of Minnesota - MinneapolisRecruiting
  • University of Minnesota/Masonic Cancer CenterRecruiting
  • Mayo Clinic in RochesterRecruiting
  • University of Mississippi Medical CenterRecruiting
  • Children's Mercy Hospitals and ClinicsRecruiting
  • Cardinal Glennon Children's Medical CenterRecruiting
  • Washington University School of MedicineRecruiting
  • Children's Hospital and Medical Center of OmahaRecruiting
  • University of Nebraska Medical CenterRecruiting
  • Morristown Medical CenterRecruiting
  • Albany Medical CenterRecruiting
  • Roswell Park Cancer InstituteRecruiting
  • NYU Winthrop HospitalRecruiting
  • The Steven and Alexandra Cohen Children's Medical Center of New YorkRecruiting
  • Laura and Isaac Perlmutter Cancer Center at NYU LangoneRecruiting
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • State University of New York Upstate Medical UniversityRecruiting
  • New York Medical CollegeRecruiting
  • UNC Lineberger Comprehensive Cancer CenterRecruiting
  • Carolinas Medical Center/Levine Cancer InstituteRecruiting
  • Duke University Medical CenterRecruiting
  • East Carolina UniversityRecruiting
  • Wake Forest University Health SciencesRecruiting
  • Sanford Broadway Medical CenterRecruiting
  • Children's Hospital Medical Center of AkronRecruiting
  • Cincinnati Children's Hospital Medical CenterRecruiting
  • Rainbow Babies and Childrens HospitalRecruiting
  • Nationwide Children's HospitalRecruiting
  • Dayton Children's HospitalRecruiting
  • University of Oklahoma Health Sciences CenterRecruiting
  • Oregon Health and Science UniversityRecruiting
  • Geisinger Medical CenterRecruiting
  • Penn State Children's HospitalRecruiting
  • Children's Hospital of PhiladelphiaRecruiting
  • Children's Hospital of Pittsburgh of UPMCRecruiting
  • Rhode Island HospitalRecruiting
  • Medical University of South CarolinaRecruiting
  • Prisma Health Richland HospitalRecruiting
  • BI-LO Charities Children's Cancer CenterRecruiting
  • East Tennessee Childrens HospitalRecruiting
  • Saint Jude Children's Research HospitalRecruiting
  • Vanderbilt University/Ingram Cancer CenterRecruiting
  • Dell Children's Medical Center of Central TexasRecruiting
  • UT Southwestern/Simmons Cancer Center-DallasRecruiting
  • El Paso Children's HospitalRecruiting
  • Cook Children's Medical CenterRecruiting
  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterRecruiting
  • M D Anderson Cancer CenterRecruiting
  • Covenant Children's HospitalRecruiting
  • UMC Cancer Center / UMC Health SystemRecruiting
  • Children's Hospital of San AntonioRecruiting
  • Methodist Children's Hospital of South TexasRecruiting
  • University of Texas Health Science Center at San AntonioRecruiting
  • Primary Children's HospitalRecruiting
  • University of Vermont and State Agricultural CollegeRecruiting
  • Children's Hospital of The King's DaughtersRecruiting
  • Virginia Commonwealth University/Massey Cancer CenterRecruiting
  • Carilion Children'sRecruiting
  • Seattle Children's HospitalRecruiting
  • Providence Sacred Heart Medical Center and Children's HospitalRecruiting
  • Mary Bridge Children's Hospital and Health CenterRecruiting
  • Madigan Army Medical CenterRecruiting
  • West Virginia University HealthcareRecruiting
  • University of Wisconsin Carbone Cancer CenterRecruiting
  • Children's Hospital of WisconsinRecruiting
  • IWK Health CentreRecruiting
  • The Montreal Children's Hospital of the MUHCRecruiting
  • Centre Hospitalier Universitaire Sainte-JustineRecruiting
  • CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)Recruiting
  • HIMA San Pablo Oncologic HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm I (vincristine sulfate, carboplatin)

Arm II (selumetinib sulfate)

Arm Description

INDUCTION: Patients receive vincristine sulfate IV over 1 minute 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) at baseline and end of induction. MAINTENANCE: Patients receive vincristine sulfate IV over 1 minute on days 1, 8, and 15, and carboplatin IV over 60 minutes on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood and undergo MRI at baseline, throughout the trial, and during follow up.

Patients receive selumetinib sulfate PO BID on days 1-28. Treatment repeats every 28 days for up to 27 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood and undergo MRI at baseline, throughout the trial, and during follow up.

Outcomes

Primary Outcome Measures

Event-free survival (EFS)
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.

Secondary Outcome Measures

Radiographic tumor response rate
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.
Overall survival (OS)
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.
Number of patients who experience an improvement in visual acuity (VA)
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.
Change in motor function
Motor function is measured using the Vineland-3 Motor Scale. Only patients with motor function deficits at baseline are included. Magnitudes of change for each patient after 48 weeks of therapy from baseline will be calculated and medians (with ranges) by treatment arm will be reported.
Change in quality of life (QOL)
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.
Processing speed function
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.
Change in executive function
Executive function will be measured by the BRIEF-2 Cognitive Regulation Index (CRI). Summary statistics for the differences in scores from baseline to 9 months will be reported by treatment arm.

Full Information

First Posted
November 15, 2019
Last Updated
October 24, 2023
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04166409
Brief Title
A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2020 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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 and vincristine are chemotherapy drugs that work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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.
Detailed Description
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, including studies to correlate genomic drivers to response. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: INDUCTION: Patients receive vincristine sulfate intravenously (IV) over 1 minute 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) at baseline and end of induction. MAINTENANCE: Patients receive vincristine sulfate IV over 1 minute on days 1, 8, and 15, and carboplatin IV over 60 minutes on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood and undergo MRI at baseline, throughout the trial, and during follow up. ARM II: Patients receive selumetinib sulfate orally (PO) twice daily (BID) on days 1-28. Treatment repeats every 28 days for up to 27 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood and undergo MRI at baseline, throughout the trial, and during follow up. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Grade Astrocytoma, Low Grade Glioma, Metastatic Low Grade Astrocytoma, Metastatic Low Grade Glioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (vincristine sulfate, carboplatin)
Arm Type
Active Comparator
Arm Description
INDUCTION: Patients receive vincristine sulfate IV over 1 minute 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) at baseline and end of induction. MAINTENANCE: Patients receive vincristine sulfate IV over 1 minute on days 1, 8, and 15, and carboplatin IV over 60 minutes on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood and undergo MRI at baseline, throughout the trial, and during follow up.
Arm Title
Arm II (selumetinib sulfate)
Arm Type
Experimental
Arm Description
Patients receive selumetinib sulfate PO BID on days 1-28. Treatment repeats every 28 days for up to 27 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood and undergo MRI at baseline, throughout the trial, and during follow up.
Intervention Type
Procedure
Intervention Name(s)
Biospecimen Collection
Other Intervention Name(s)
Biological Sample Collection, Biospecimen Collected, Specimen Collection
Intervention Description
Correlative studies
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, JM8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Imaging
Other Intervention Name(s)
Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging
Intervention Description
Undergo MRI
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Drug
Intervention Name(s)
Selumetinib Sulfate
Other Intervention Name(s)
AZD-6244 Hydrogen Sulfate, AZD6244 Hydrogen Sulfate, AZD6244 Hydrogen Sulphate, Koselugo, Selumetinib Sulphate
Intervention Description
Given PO
Intervention Type
Drug
Intervention Name(s)
Vincristine Sulfate
Other Intervention Name(s)
Kyocristine, Leurocristine Sulfate, Leurocristine, sulfate, Oncovin, Vincasar, Vincosid, Vincrex, Vincristine, sulfate
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Event-free survival (EFS)
Description
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.
Time Frame
Up to 10 years from date of randomization
Secondary Outcome Measure Information:
Title
Radiographic tumor response rate
Description
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.
Time Frame
Up to 10 years
Title
Overall survival (OS)
Description
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.
Time Frame
Up to 10 years from date of randomization
Title
Number of patients who experience an improvement in visual acuity (VA)
Description
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.
Time Frame
After the first 12 months of treatment
Title
Change in motor function
Description
Motor function is measured using the Vineland-3 Motor Scale. Only patients with motor function deficits at baseline are included. Magnitudes of change for each patient after 48 weeks of therapy from baseline will be calculated and medians (with ranges) by treatment arm will be reported.
Time Frame
After 48 weeks of therapy
Title
Change in quality of life (QOL)
Description
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.
Time Frame
Baseline and 9 months after treatment initiation
Title
Processing speed function
Description
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.
Time Frame
Up to 9 months post-treatment initiation
Title
Change in executive function
Description
Executive function will be measured by the BRIEF-2 Cognitive Regulation Index (CRI). Summary statistics for the differences in scores from baseline to 9 months will be reported by treatment arm.
Time Frame
Baseline and 9-months
Other Pre-specified Outcome Measures:
Title
Change in QOL scores over time
Description
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.
Time Frame
At baseline, 9 months, 30 months, and 60 months after treatment initiation
Title
Change in neurocognitive functioning scores over time
Description
Neurocognitive functioning scores for each index/scale of the Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) 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.
Time Frame
At baseline, 9 months, 30 months, and 60 months after treatment initiation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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) 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 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/gender 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 should be stable and should 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 gender 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 4 weeks prior to enrollment For all patients, a magnetic resonance imaging (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 4 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 have signed an appropriate consent form and Health Insurance Portability and Accountability Act (HIPAA) authorization form (if applicable) All patients and/or their parents or legal guardians must sign a written informed consent All patients have been consented and enrolled on APEC14B1 (NCT02402244) followed by enrollment on the ACNS1833 Pre-Enrollment Eligibility Screening (Step 0) on the same day to complete the Rapid Central Review 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 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 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter M de Blank
Organizational Affiliation
Children's Oncology Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
205-638-9285
Email
oncologyresearch@peds.uab.edu
First Name & Middle Initial & Last Name & Degree
Laura K. Metrock
Facility Name
Banner Children's at Desert
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
480-412-3100
First Name & Middle Initial & Last Name & Degree
Joseph C. Torkildson
Facility Name
Phoenix Childrens Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
602-546-0920
First Name & Middle Initial & Last Name & Degree
Lindsey M. Hoffman
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202-3591
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
501-364-7373
First Name & Middle Initial & Last Name & Degree
David L. Becton
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
909-558-4050
First Name & Middle Initial & Last Name & Degree
Albert Kheradpour
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
323-361-4110
First Name & Middle Initial & Last Name & Degree
Nathan J. Robison
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
310-423-8965
First Name & Middle Initial & Last Name & Degree
Fataneh (Fae) Majlessipour
Facility Name
Mattel Children's Hospital UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
310-825-6708
First Name & Middle Initial & Last Name & Degree
Satiro N. De Oliveira
Facility Name
Kaiser Permanente-Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-642-4691
Email
Kpoct@kp.org
First Name & Middle Initial & Last Name & Degree
Aarati V. Rao
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
714-509-8646
Email
oncresearch@choc.org
First Name & Middle Initial & Last Name & Degree
Elyssa M. Rubin
Facility Name
Lucile Packard Children's Hospital Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-694-0012
Email
ccto-office@stanford.edu
First Name & Middle Initial & Last Name & Degree
Jay Michael S. Balagtas
Facility Name
Rady Children's Hospital - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
858-966-5934
First Name & Middle Initial & Last Name & Degree
William D. Roberts
Facility Name
UCSF Medical Center-Mission Bay
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-827-3222
Email
cancertrials@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Alyssa T. Reddy
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
303-764-5056
Email
josh.b.gordon@nsmtp.kp.org
First Name & Middle Initial & Last Name & Degree
Jean M. Mulcahy Levy
Facility Name
Connecticut Children's Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
860-545-9981
First Name & Middle Initial & Last Name & Degree
Michael S. Isakoff
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
203-785-5702
Email
canceranswers@yale.edu
First Name & Middle Initial & Last Name & Degree
Asher M. Marks
Facility Name
Alfred I duPont Hospital for Children
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
302-651-5572
Email
Allison.bruce@nemours.org
First Name & Middle Initial & Last Name & Degree
Scott M. Bradfield
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
202-476-2800
Email
OncCRC_OnCall@childrensnational.org
First Name & Middle Initial & Last Name & Degree
Jeffrey S. Dome
Facility Name
University of Florida Health Science Center - Gainesville
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
352-273-8010
Email
cancer-center@ufl.edu
First Name & Middle Initial & Last Name & Degree
William B. Slayton
Facility Name
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
954-265-1847
Email
OHR@mhs.net
First Name & Middle Initial & Last Name & Degree
Iftikhar Hanif
Facility Name
Nemours Children's Clinic-Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
302-651-5572
Email
Allison.bruce@nemours.org
First Name & Middle Initial & Last Name & Degree
Scott M. Bradfield
Facility Name
University of Miami Miller School of Medicine-Sylvester Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Withdrawn
Facility Name
Nicklaus Children's Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
888-624-2778
First Name & Middle Initial & Last Name & Degree
Ziad A. Khatib
Facility Name
AdventHealth Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
407-303-2090
Email
FH.Cancer.Research@flhosp.org
First Name & Middle Initial & Last Name & Degree
Fouad M. Hajjar
Facility Name
Arnold Palmer Hospital for Children
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
321-841-5357
Email
Jennifer.spinelli@orlandohealth.com
First Name & Middle Initial & Last Name & Degree
Amy A. Smith
Facility Name
Nemours Children's Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32827
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
302-651-5572
Email
Allison.bruce@nemours.org
First Name & Middle Initial & Last Name & Degree
Scott M. Bradfield
Facility Name
Sacred Heart Hospital
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
850-416-4611
Email
eebrou@ascension.org
First Name & Middle Initial & Last Name & Degree
Erlyn C. Smith
Facility Name
Johns Hopkins All Children's Hospital
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
727-767-4784
Email
Ashley.Repp@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Stacie L. Stapleton
Facility Name
Children's Healthcare of Atlanta - Egleston
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
404-785-2025
Email
Leann.Schilling@choa.org
First Name & Middle Initial & Last Name & Degree
Jason R. Fangusaro
Facility Name
Kapiolani Medical Center for Women and Children
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96826
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
808-983-6090
First Name & Middle Initial & Last Name & Degree
Wade T. Kyono
Facility Name
Saint Luke's Cancer Institute - Boise
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
208-381-2774
Email
eslinget@slhs.org
First Name & Middle Initial & Last Name & Degree
Martha M. Pacheco
Facility Name
Lurie Children's Hospital-Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
773-880-4562
First Name & Middle Initial & Last Name & Degree
Angela J. Waanders
Facility Name
University of Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
312-355-3046
First Name & Middle Initial & Last Name & Degree
Mary L. Schmidt
Facility Name
University of Chicago Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
773-702-8222
Email
cancerclinicaltrials@bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Wendy S. Darlington
Facility Name
Southern Illinois University School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
217-545-7929
First Name & Middle Initial & Last Name & Degree
Gregory P. Brandt
Facility Name
Riley Hospital for Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-248-1199
First Name & Middle Initial & Last Name & Degree
Sandeep Batra
Facility Name
Ascension Saint Vincent Indianapolis Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
317-338-2194
Email
research@stvincent.org
First Name & Middle Initial & Last Name & Degree
Jessica F. Goodman
Facility Name
Blank Children's Hospital
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
515-241-8912
Email
samantha.mallory@unitypoint.org
First Name & Middle Initial & Last Name & Degree
Samantha L. Mallory
Facility Name
University of Iowa/Holden Comprehensive Cancer Center
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-237-1225
First Name & Middle Initial & Last Name & Degree
David S. Dickens
Facility Name
University of Kentucky/Markey Cancer Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
859-257-3379
First Name & Middle Initial & Last Name & Degree
James T. Badgett
Facility Name
Norton Children's Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
502-629-5500
Email
CancerResource@nortonhealthcare.org
First Name & Middle Initial & Last Name & Degree
Ashok B. Raj
Facility Name
Children's Hospital New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
CHResearch@lcmchealth.org
First Name & Middle Initial & Last Name & Degree
Lolie C. Yu
Facility Name
Eastern Maine Medical Center
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
207-973-4274
First Name & Middle Initial & Last Name & Degree
Daniel L. Callaway
Facility Name
Maine Children's Cancer Program
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
207-396-7581
Email
sverwys@mmc.org
First Name & Middle Initial & Last Name & Degree
Stanley Chaleff
Facility Name
Johns Hopkins University/Sidney Kimmel Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
410-955-8804
Email
jhcccro@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Kenneth J. Cohen
Facility Name
Walter Reed National Military Medical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889-5600
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
301-319-2100
First Name & Middle Initial & Last Name & Degree
Allen I. Stering
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-726-5130
First Name & Middle Initial & Last Name & Degree
David H. Ebb
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-442-3324
First Name & Middle Initial & Last Name & Degree
Susan N. Chi
Facility Name
C S Mott Children's Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-865-1125
First Name & Middle Initial & Last Name & Degree
Andrea T. Franson
Facility Name
Children's Hospital of Michigan
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
helpdesk@childrensoncologygroup.org
First Name & Middle Initial & Last Name & Degree
Stephanie A. Toll
Facility Name
Helen DeVos Children's Hospital at Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
616-391-1230
Email
crcwm-regulatory@crcwm.org
First Name & Middle Initial & Last Name & Degree
Kathleen J. Yost
Facility Name
Beaumont Children's Hospital-Royal Oak
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
248-551-7695
First Name & Middle Initial & Last Name & Degree
Laura K. Gowans
Facility Name
Children's Hospitals and Clinics of Minnesota - Minneapolis
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
612-813-5913
Email
pauline.mitby@childrensmn.org
First Name & Middle Initial & Last Name & Degree
Michael K. Richards
Facility Name
University of Minnesota/Masonic Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
612-624-2620
First Name & Middle Initial & Last Name & Degree
Christopher L. Moertel
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
855-776-0015
First Name & Middle Initial & Last Name & Degree
Jonathan D. Schwartz
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
601-815-6700
First Name & Middle Initial & Last Name & Degree
Betty L. Herrington
Facility Name
Children's Mercy Hospitals and Clinics
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
816-302-6808
Email
rryan@cmh.edu
First Name & Middle Initial & Last Name & Degree
Keith J. August
Facility Name
Cardinal Glennon Children's Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
314-268-4000
First Name & Middle Initial & Last Name & Degree
William S. Ferguson
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-600-3606
Email
info@siteman.wustl.edu
First Name & Middle Initial & Last Name & Degree
Andrew S. Cluster
Facility Name
Children's Hospital and Medical Center of Omaha
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
402-955-3949
First Name & Middle Initial & Last Name & Degree
Jill C. Beck
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
402-559-6941
Email
unmcrsa@unmc.edu
First Name & Middle Initial & Last Name & Degree
Jill C. Beck
Facility Name
Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
973-971-5900
First Name & Middle Initial & Last Name & Degree
Kathryn L. Laurie
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
518-262-5513
First Name & Middle Initial & Last Name & Degree
Lauren R. Weintraub
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-767-9355
Email
askroswell@roswellpark.org
First Name & Middle Initial & Last Name & Degree
Matthew J. Barth
Facility Name
NYU Winthrop Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
212-263-4432
Email
cancertrials@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Chana L. Glasser
Facility Name
The Steven and Alexandra Cohen Children's Medical Center of New York
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
718-470-3460
First Name & Middle Initial & Last Name & Degree
Mark P. Atlas
Facility Name
Laura and Isaac Perlmutter Cancer Center at NYU Langone
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
CancerTrials@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Sharon L. Gardner
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
212-639-7592
First Name & Middle Initial & Last Name & Degree
Sameer Farouk Sait
Facility Name
State University of New York Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
315-464-5476
First Name & Middle Initial & Last Name & Degree
Philip M. Monteleone
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
914-594-3794
First Name & Middle Initial & Last Name & Degree
Jessica C. Hochberg
Facility Name
UNC Lineberger Comprehensive Cancer Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-668-0683
Email
cancerclinicaltrials@med.unc.edu
First Name & Middle Initial & Last Name & Degree
David E. Kram
Facility Name
Carolinas Medical Center/Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-804-9376
First Name & Middle Initial & Last Name & Degree
Joel A. Kaplan
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
888-275-3853
First Name & Middle Initial & Last Name & Degree
Jessica M. Sun
Facility Name
East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
252-744-1015
Email
eubankss@ecu.edu
First Name & Middle Initial & Last Name & Degree
Andrea R. Whitfield
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
336-713-6771
First Name & Middle Initial & Last Name & Degree
Thomas W. McLean
Facility Name
Sanford Broadway Medical Center
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
701-323-5760
Email
OncologyClinicalTrialsFargo@sanfordhealth.org
First Name & Middle Initial & Last Name & Degree
Samuel J. Milanovich
Facility Name
Children's Hospital Medical Center of Akron
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
330-543-3193
First Name & Middle Initial & Last Name & Degree
Erin Wright
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
513-636-2799
Email
cancer@cchmc.org
First Name & Middle Initial & Last Name & Degree
Peter M. de Blank
Facility Name
Rainbow Babies and Childrens Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
216-844-5437
First Name & Middle Initial & Last Name & Degree
Duncan S. Stearns
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
614-722-6039
Email
Melinda.Triplet@nationwidechildrens.org
First Name & Middle Initial & Last Name & Degree
Mark A. Ranalli
Facility Name
Dayton Children's Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-228-4055
First Name & Middle Initial & Last Name & Degree
Mukund G. Dole
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
405-271-8777
Email
ou-clinical-trials@ouhsc.edu
First Name & Middle Initial & Last Name & Degree
Rene Y. McNall-Knapp
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
503-494-1080
Email
trials@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Linda C. Stork
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
570-271-5251
Email
HemonCCTrials@geisinger.edu
First Name & Middle Initial & Last Name & Degree
Jagadeesh Ramdas
Facility Name
Penn State Children's Hospital
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
717-531-6012
First Name & Middle Initial & Last Name & Degree
Lisa M. McGregor
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
267-425-5544
Email
CancerTrials@email.chop.edu
First Name & Middle Initial & Last Name & Degree
Michael J. Fisher
Facility Name
Children's Hospital of Pittsburgh of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-692-8570
Email
jean.tersak@chp.edu
First Name & Middle Initial & Last Name & Degree
James T. Felker
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
401-444-1488
First Name & Middle Initial & Last Name & Degree
Jennifer J. Welch
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
843-792-9321
Email
hcc-clinical-trials@musc.edu
First Name & Middle Initial & Last Name & Degree
Jacqueline M. Kraveka
Facility Name
Prisma Health Richland Hospital
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
864-241-6251
First Name & Middle Initial & Last Name & Degree
Stuart L. Cramer
Facility Name
BI-LO Charities Children's Cancer Center
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
864-241-6251
First Name & Middle Initial & Last Name & Degree
Aniket Saha
Facility Name
East Tennessee Childrens Hospital
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37916
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
865-541-8266
First Name & Middle Initial & Last Name & Degree
Susan E. Spiller
Facility Name
Saint Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
888-226-4343
Email
referralinfo@stjude.org
First Name & Middle Initial & Last Name & Degree
Amar Gajjar
Facility Name
Vanderbilt University/Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-811-8480
First Name & Middle Initial & Last Name & Degree
Devang J. Pastakia
Facility Name
Dell Children's Medical Center of Central Texas
City
Austin
State/Province
Texas
ZIP/Postal Code
78723
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
512-628-1902
Email
TXAUS-DL-SFCHemonc.research@ascension.org
First Name & Middle Initial & Last Name & Degree
Shannon M. Cohn
Facility Name
UT Southwestern/Simmons Cancer Center-Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
214-648-7097
Email
canceranswerline@UTSouthwestern.edu
First Name & Middle Initial & Last Name & Degree
Daniel C. Bowers
Facility Name
El Paso Children's Hospital
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
915-298-5444
Email
ranjan.bista@ttuhsc.edu
First Name & Middle Initial & Last Name & Degree
Ranjan Bista
Facility Name
Cook Children's Medical Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
682-885-2103
Email
CookChildrensResearch@cookchildrens.org
First Name & Middle Initial & Last Name & Degree
Sibo Zhao
Facility Name
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
713-798-1354
Email
burton@bcm.edu
First Name & Middle Initial & Last Name & Degree
Murali M. Chintagumpala
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-632-6789
Email
askmdanderson@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Najat C. Daw
Facility Name
Covenant Children's Hospital
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
806-725-8657
Email
mbisbee@providence.org
First Name & Middle Initial & Last Name & Degree
Kishor M. Bhende
Facility Name
UMC Cancer Center / UMC Health System
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79415
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
806-775-8590
First Name & Middle Initial & Last Name & Degree
Erin K. Barr
Facility Name
Children's Hospital of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
210-704-2894
Email
bridget.medina@christushealth.org
First Name & Middle Initial & Last Name & Degree
Timothy C. Griffin
Facility Name
Methodist Children's Hospital of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
210-575-6240
Email
Vinod.GidvaniDiaz@hcahealthcare.com
First Name & Middle Initial & Last Name & Degree
Jose M. Esquilin
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
210-450-3800
Email
phoresearchoffice@uthscsa.edu
First Name & Middle Initial & Last Name & Degree
Anne-Marie R. Langevin
Facility Name
Primary Children's Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
801-585-5270
First Name & Middle Initial & Last Name & Degree
Priya Chan
Facility Name
University of Vermont and State Agricultural College
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
802-656-8990
Email
rpo@uvm.edu
First Name & Middle Initial & Last Name & Degree
Jessica L. Heath
Facility Name
Children's Hospital of The King's Daughters
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
757-668-7243
Email
CCBDCresearch@chkd.org
First Name & Middle Initial & Last Name & Degree
Eric J. Lowe
Facility Name
Virginia Commonwealth University/Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
CTOclinops@vcu.edu
First Name & Middle Initial & Last Name & Degree
Zhihong J. Wang
Facility Name
Carilion Children's
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
540-266-6238
Email
wpmccarty@carilionclinic.org
First Name & Middle Initial & Last Name & Degree
Erwood G. Edwards
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
866-987-2000
First Name & Middle Initial & Last Name & Degree
Sarah E. Leary
Facility Name
Providence Sacred Heart Medical Center and Children's Hospital
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-228-6618
Email
HopeBeginsHere@providence.org
First Name & Middle Initial & Last Name & Degree
Judy L. Felgenhauer
Facility Name
Mary Bridge Children's Hospital and Health Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
253-403-1461
Email
research@multicare.org
First Name & Middle Initial & Last Name & Degree
Robert G. Irwin
Facility Name
Madigan Army Medical Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
253-968-6144
Email
melissa.a.forouhar.mil@health.mil
First Name & Middle Initial & Last Name & Degree
Melissa A. Forouhar
Facility Name
West Virginia University Healthcare
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
304-293-7374
Email
cancertrialsinfo@hsc.wvu.edu
First Name & Middle Initial & Last Name & Degree
Ashley E. Meyer
Facility Name
University of Wisconsin Carbone Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-622-8922
First Name & Middle Initial & Last Name & Degree
Kenneth B. De Santes
Facility Name
Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
414-955-4727
Email
MACCCTO@mcw.edu
First Name & Middle Initial & Last Name & Degree
Sarah Rumler
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
902-470-8520
Email
Research@iwk.nshealth.ca
First Name & Middle Initial & Last Name & Degree
Craig Erker
Facility Name
The Montreal Children's Hospital of the MUHC
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 1P3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
514-412-4445
Email
info@thechildren.com
First Name & Middle Initial & Last Name & Degree
Sharon B. Abish
Facility Name
Centre Hospitalier Universitaire Sainte-Justine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
514-345-4931
Email
yvan.samson@umontreal.ca
First Name & Middle Initial & Last Name & Degree
Yvan Samson
Facility Name
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
City
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
418-525-4444
Email
rechclinique@crchudequebec.ulaval.ca
First Name & Middle Initial & Last Name & Degree
Bruno Michon
Facility Name
HIMA San Pablo Oncologic Hospital
City
Caguas
ZIP/Postal Code
00726
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
787-653-3434
First Name & Middle Initial & Last Name & Degree
Jhon A. Guerra

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing URL
https://grants.nih.gov/policy/sharing.htm
Citations:
PubMed Identifier
33395032
Citation
Bergqvist C, Wolkenstein P. MEK inhibitors in RASopathies. Curr Opin Oncol. 2021 Mar 1;33(2):110-119. doi: 10.1097/CCO.0000000000000711.
Results Reference
derived
PubMed Identifier
32597469
Citation
Arnold A, Rodriguez F, Eberhart CG, Raabe EH. Response to letter to the editor: "All models are wrong; some models are useful". Neuro Oncol. 2020 Sep 29;22(9):1406-1407. doi: 10.1093/neuonc/noaa137. No abstract available.
Results Reference
derived

Learn more about this trial

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

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