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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	2 Years - 21 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04166409
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	National Cancer Institute (NCI)
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Peter M de Blank
Principal Investigator Affiliation	Children's Oncology Group
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	NIH
Overall Status	Recruiting
Countries	Canada, Puerto Rico, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Low Grade Astrocytoma, Low Grade Glioma, Metastatic Low Grade Astrocytoma, Metastatic Low Grade Glioma

Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Arm I (vincristine sulfate, carboplatin)

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.

Experimental: Arm II (selumetinib sulfate)

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.

Interventions

Procedure: - Biospecimen Collection

Correlative studies

Drug: - Carboplatin

Given IV

Procedure: - Magnetic Resonance Imaging

Undergo MRI

Other: - Quality-of-Life Assessment

Ancillary studies

Other: - Questionnaire Administration

Ancillary studies

Drug: - Selumetinib Sulfate

Given PO

Drug: - Vincristine Sulfate

Given IV

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Children's Hospital of Alabama, Birmingham, Alabama

Status

Suspended

Address

Children's Hospital of Alabama

Birmingham, Alabama, 35233

Banner Children's at Desert, Mesa, Arizona

Status

Recruiting

Address

Banner Children's at Desert

Mesa, Arizona, 85202

Site Contact

Site Public Contact

480-412-3100

Phoenix Childrens Hospital, Phoenix, Arizona

Status

Recruiting

Address

Phoenix Childrens Hospital

Phoenix, Arizona, 85016

Site Contact

Site Public Contact

602-546-0920

Arkansas Children's Hospital, Little Rock, Arkansas

Status

Recruiting

Address

Arkansas Children's Hospital

Little Rock, Arkansas, 72202-3591

Site Contact

Site Public Contact

501-364-7373

Loma Linda University Medical Center, Loma Linda, California

Status

Recruiting

Address

Loma Linda University Medical Center

Loma Linda, California, 92354

Site Contact

Site Public Contact

909-558-4050

Children's Hospital Los Angeles, Los Angeles, California

Status

Recruiting

Address

Children's Hospital Los Angeles

Los Angeles, California, 90027

Site Contact

Site Public Contact

323-361-4110

Cedars Sinai Medical Center, Los Angeles, California

Status

Recruiting

Address

Cedars Sinai Medical Center

Los Angeles, California, 90048

Site Contact

Site Public Contact

310-423-8965

Mattel Children's Hospital UCLA, Los Angeles, California

Status

Recruiting

Address

Mattel Children's Hospital UCLA

Los Angeles, California, 90095

Site Contact

Site Public Contact

310-825-6708

Kaiser Permanente-Oakland, Oakland, California

Status

Recruiting

Address

Kaiser Permanente-Oakland

Oakland, California, 94611

Site Contact

Site Public Contact

[email protected]

877-642-4691

Children's Hospital of Orange County, Orange, California

Status

Recruiting

Address

Children's Hospital of Orange County

Orange, California, 92868

Site Contact

Site Public Contact

[email protected]

714-509-8646

Palo Alto, California

Status

Recruiting

Address

Lucile Packard Children's Hospital Stanford University

Palo Alto, California, 94304

Site Contact

Site Public Contact

[email protected]

800-694-0012

Rady Children's Hospital - San Diego, San Diego, California

Status

Recruiting

Address

Rady Children's Hospital - San Diego

San Diego, California, 92123

Site Contact

Site Public Contact

858-966-5934

UCSF Medical Center-Mission Bay, San Francisco, California

Status

Recruiting

Address

UCSF Medical Center-Mission Bay

San Francisco, California, 94158

Site Contact

Site Public Contact

[email protected]

877-827-3222

Children's Hospital Colorado, Aurora, Colorado

Status

Recruiting

Address

Children's Hospital Colorado

Aurora, Colorado, 80045

Site Contact

Site Public Contact

[email protected]

303-764-5056

Connecticut Children's Medical Center, Hartford, Connecticut

Status

Recruiting

Address

Connecticut Children's Medical Center

Hartford, Connecticut, 06106

Site Contact

Site Public Contact

860-545-9981

Yale University, New Haven, Connecticut

Status

Recruiting

Address

Yale University

New Haven, Connecticut, 06520

Site Contact

Site Public Contact

[email protected]

203-785-5702

Alfred I duPont Hospital for Children, Wilmington, Delaware

Status

Recruiting

Address

Alfred I duPont Hospital for Children

Wilmington, Delaware, 19803

Site Contact

Site Public Contact

[email protected]

302-651-5572

Children's National Medical Center, Washington, District of Columbia

Status

Recruiting

Address

Children's National Medical Center

Washington, District of Columbia, 20010

Site Contact

Site Public Contact

[email protected]

202-476-2800

Gainesville, Florida

Status

Active, not recruiting

Address

University of Florida Health Science Center - Gainesville

Gainesville, Florida, 32610

Hollywood, Florida

Status

Recruiting

Address

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Hollywood, Florida, 33021

Site Contact

Site Public Contact

[email protected]

954-265-1847

Nemours Children's Clinic-Jacksonville, Jacksonville, Florida

Status

Recruiting

Address

Nemours Children's Clinic-Jacksonville

Jacksonville, Florida, 32207

Site Contact

Site Public Contact

[email protected]

302-651-5572

Miami, Florida

Status

Withdrawn

Address

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136

Nicklaus Children's Hospital, Miami, Florida

Status

Recruiting

Address

Nicklaus Children's Hospital

Miami, Florida, 33155

Site Contact

Site Public Contact

888-624-2778

AdventHealth Orlando, Orlando, Florida

Status

Recruiting

Address

AdventHealth Orlando

Orlando, Florida, 32803

Site Contact

Site Public Contact

[email protected]

407-303-2090

Arnold Palmer Hospital for Children, Orlando, Florida

Status

Recruiting

Address

Arnold Palmer Hospital for Children

Orlando, Florida, 32806

Site Contact

Site Public Contact

[email protected]

321-841-5357

Nemours Children's Hospital, Orlando, Florida

Status

Recruiting

Address

Nemours Children's Hospital

Orlando, Florida, 32827

Site Contact

Site Public Contact

[email protected]

302-651-5572

Sacred Heart Hospital, Pensacola, Florida

Status

Recruiting

Address

Sacred Heart Hospital

Pensacola, Florida, 32504

Site Contact

Site Public Contact

[email protected]

850-416-4611

Johns Hopkins All Children's Hospital, Saint Petersburg, Florida

Status

Recruiting

Address

Johns Hopkins All Children's Hospital

Saint Petersburg, Florida, 33701

Site Contact

Site Public Contact

[email protected]

727-767-4784

Atlanta, Georgia

Status

Recruiting

Address

Children's Healthcare of Atlanta - Egleston

Atlanta, Georgia, 30322

Site Contact

Site Public Contact

[email protected]

404-785-2025

Honolulu, Hawaii

Status

Recruiting

Address

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826

Site Contact

Site Public Contact

808-983-6090

Saint Luke's Cancer Institute - Boise, Boise, Idaho

Status

Recruiting

Address

Saint Luke's Cancer Institute - Boise

Boise, Idaho, 83712

Site Contact

Site Public Contact

[email protected]

208-381-2774

Lurie Children's Hospital-Chicago, Chicago, Illinois

Status

Recruiting

Address

Lurie Children's Hospital-Chicago

Chicago, Illinois, 60611

Site Contact

Site Public Contact

773-880-4562

University of Illinois, Chicago, Illinois

Status

Recruiting

Address

University of Illinois

Chicago, Illinois, 60612

Site Contact

Site Public Contact

312-355-3046

Chicago, Illinois

Status

Recruiting

Address

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637

Site Contact

Site Public Contact

[email protected]

773-702-8222

Springfield, Illinois

Status

Recruiting

Address

Southern Illinois University School of Medicine

Springfield, Illinois, 62702

Site Contact

Site Public Contact

217-545-7929

Riley Hospital for Children, Indianapolis, Indiana

Status

Recruiting

Address

Riley Hospital for Children

Indianapolis, Indiana, 46202

Site Contact

Site Public Contact

800-248-1199

Indianapolis, Indiana

Status

Recruiting

Address

Ascension Saint Vincent Indianapolis Hospital

Indianapolis, Indiana, 46260

Site Contact

Site Public Contact

[email protected]

317-338-2194

Blank Children's Hospital, Des Moines, Iowa

Status

Recruiting

Address

Blank Children's Hospital

Des Moines, Iowa, 50309

Site Contact

Site Public Contact

[email protected]

515-241-8912

Iowa City, Iowa

Status

Recruiting

Address

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242

Site Contact

Site Public Contact

800-237-1225

Lexington, Kentucky

Status

Recruiting

Address

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536

Site Contact

Site Public Contact

859-257-3379

Norton Children's Hospital, Louisville, Kentucky

Status

Recruiting

Address

Norton Children's Hospital

Louisville, Kentucky, 40202

Site Contact

Site Public Contact

[email protected]

502-629-5500

Children's Hospital New Orleans, New Orleans, Louisiana

Status

Recruiting

Address

Children's Hospital New Orleans

New Orleans, Louisiana, 70118

Site Contact

Site Public Contact

[email protected]

Eastern Maine Medical Center, Bangor, Maine

Status

Recruiting

Address

Eastern Maine Medical Center

Bangor, Maine, 04401

Site Contact

Site Public Contact

207-973-4274

Maine Children's Cancer Program, Scarborough, Maine

Status

Recruiting

Address

Maine Children's Cancer Program

Scarborough, Maine, 04074

Site Contact

Site Public Contact

[email protected]

207-396-7581

Baltimore, Maryland

Status

Recruiting

Address

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287

Site Contact

Site Public Contact

[email protected]

410-955-8804

Bethesda, Maryland

Status

Recruiting

Address

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889-5600

Site Contact

Site Public Contact

301-319-2100

Boston, Massachusetts

Status

Recruiting

Address

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114

Site Contact

Site Public Contact

877-726-5130

Dana-Farber Cancer Institute, Boston, Massachusetts

Status

Active, not recruiting

Address

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

C S Mott Children's Hospital, Ann Arbor, Michigan

Status

Recruiting

Address

C S Mott Children's Hospital

Ann Arbor, Michigan, 48109

Site Contact

Site Public Contact

800-865-1125

Children's Hospital of Michigan, Detroit, Michigan

Status

Recruiting

Address

Children's Hospital of Michigan

Detroit, Michigan, 48201

Site Contact

Site Public Contact

[email protected]

Grand Rapids, Michigan

Status

Recruiting

Address

Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

Grand Rapids, Michigan, 49503

Site Contact

Site Public Contact

[email protected]

616-267-1925

Beaumont Children's Hospital-Royal Oak, Royal Oak, Michigan

Status

Recruiting

Address

Beaumont Children's Hospital-Royal Oak

Royal Oak, Michigan, 48073

Site Contact

Site Public Contact

248-551-7695

Minneapolis, Minnesota

Status

Recruiting

Address

Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis, Minnesota, 55404

Site Contact

Site Public Contact

[email protected]

612-813-5913

Minneapolis, Minnesota

Status

Recruiting

Address

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, 55455

Site Contact

Site Public Contact

612-624-2620

Mayo Clinic in Rochester, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

Site Contact

Site Public Contact

855-776-0015

University of Mississippi Medical Center, Jackson, Mississippi

Status

Recruiting

Address

University of Mississippi Medical Center

Jackson, Mississippi, 39216

Site Contact

Site Public Contact

601-815-6700

Children's Mercy Hospitals and Clinics, Kansas City, Missouri

Status

Recruiting

Address

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108

Site Contact

Site Public Contact

[email protected]

816-302-6808

Saint Louis, Missouri

Status

Recruiting

Address

Cardinal Glennon Children's Medical Center

Saint Louis, Missouri, 63104

Site Contact

Site Public Contact

314-268-4000

Washington University School of Medicine, Saint Louis, Missouri

Status

Recruiting

Address

Washington University School of Medicine

Saint Louis, Missouri, 63110

Site Contact

Site Public Contact

[email protected]

800-600-3606

Omaha, Nebraska

Status

Recruiting

Address

Children's Hospital and Medical Center of Omaha

Omaha, Nebraska, 68114

Site Contact

Site Public Contact

402-955-3949

University of Nebraska Medical Center, Omaha, Nebraska

Status

Recruiting

Address

University of Nebraska Medical Center

Omaha, Nebraska, 68198

Site Contact

Site Public Contact

[email protected]

402-559-6941

Morristown Medical Center, Morristown, New Jersey

Status

Recruiting

Address

Morristown Medical Center

Morristown, New Jersey, 07960

Site Contact

Site Public Contact

973-971-5900

Albany Medical Center, Albany, New York

Status

Recruiting

Address

Albany Medical Center

Albany, New York, 12208

Site Contact

Site Public Contact

518-262-5513

Roswell Park Cancer Institute, Buffalo, New York

Status

Recruiting

Address

Roswell Park Cancer Institute

Buffalo, New York, 14263

Site Contact

Site Public Contact

[email protected]

800-767-9355

NYU Langone Hospital - Long Island, Mineola, New York

Status

Recruiting

Address

NYU Langone Hospital - Long Island

Mineola, New York, 11501

Site Contact

Site Public Contact

[email protected]

212-263-4432

New Hyde Park, New York

Status

Recruiting

Address

The Steven and Alexandra Cohen Children's Medical Center of New York

New Hyde Park, New York, 11040

Site Contact

Site Public Contact

718-470-3460

New York, New York

Status

Recruiting

Address

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, 10016

Site Contact

Site Public Contact

[email protected]

Memorial Sloan Kettering Cancer Center, New York, New York

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Site Contact

Site Public Contact

212-639-7592

Syracuse, New York

Status

Recruiting

Address

State University of New York Upstate Medical University

Syracuse, New York, 13210

Site Contact

Site Public Contact

315-464-5476

New York Medical College, Valhalla, New York

Status

Recruiting

Address

New York Medical College

Valhalla, New York, 10595

Site Contact

Site Public Contact

914-594-3794

Chapel Hill, North Carolina

Status

Recruiting

Address

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599

Site Contact

Site Public Contact

[email protected]

877-668-0683

Charlotte, North Carolina

Status

Recruiting

Address

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, 28203

Site Contact

Site Public Contact

800-804-9376

Duke University Medical Center, Durham, North Carolina

Status

Recruiting

Address

Duke University Medical Center

Durham, North Carolina, 27710

Site Contact

Site Public Contact

888-275-3853

East Carolina University, Greenville, North Carolina

Status

Recruiting

Address

East Carolina University

Greenville, North Carolina, 27834

Site Contact

Site Public Contact

[email protected]

252-744-1015

Wake Forest University Health Sciences, Winston-Salem, North Carolina

Status

Recruiting

Address

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157

Site Contact

Site Public Contact

336-713-6771

Sanford Broadway Medical Center, Fargo, North Dakota

Status

Recruiting

Address

Sanford Broadway Medical Center

Fargo, North Dakota, 58122

Site Contact

Site Public Contact

[email protected]

701-323-5760

Akron, Ohio

Status

Recruiting

Address

Children's Hospital Medical Center of Akron

Akron, Ohio, 44308

Site Contact

Site Public Contact

330-543-3193

Cincinnati, Ohio

Status

Recruiting

Address

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

Site Contact

Site Public Contact

[email protected]

513-636-2799

Rainbow Babies and Childrens Hospital, Cleveland, Ohio

Status

Recruiting

Address

Rainbow Babies and Childrens Hospital

Cleveland, Ohio, 44106

Site Contact

Site Public Contact

216-844-5437

Nationwide Children's Hospital, Columbus, Ohio

Status

Recruiting

Address

Nationwide Children's Hospital

Columbus, Ohio, 43205

Site Contact

Site Public Contact

[email protected]

614-722-6039

Dayton Children's Hospital, Dayton, Ohio

Status

Recruiting

Address

Dayton Children's Hospital

Dayton, Ohio, 45404

Site Contact

Site Public Contact

800-228-4055

Oklahoma City, Oklahoma

Status

Recruiting

Address

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

Site Contact

Site Public Contact

[email protected]

405-271-8777

Oregon Health and Science University, Portland, Oregon

Status

Recruiting

Address

Oregon Health and Science University

Portland, Oregon, 97239

Site Contact

Site Public Contact

[email protected]

503-494-1080

Geisinger Medical Center, Danville, Pennsylvania

Status

Recruiting

Address

Geisinger Medical Center

Danville, Pennsylvania, 17822

Site Contact

Site Public Contact

[email protected]

570-271-5251

Penn State Children's Hospital, Hershey, Pennsylvania

Status

Recruiting

Address

Penn State Children's Hospital

Hershey, Pennsylvania, 17033

Site Contact

Site Public Contact

717-531-6012

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

Status

Recruiting

Address

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

Site Contact

Site Public Contact

[email protected]

267-425-5544

Pittsburgh, Pennsylvania

Status

Recruiting

Address

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224

Site Contact

Site Public Contact

[email protected]

412-692-8570

Rhode Island Hospital, Providence, Rhode Island

Status

Recruiting

Address

Rhode Island Hospital

Providence, Rhode Island, 02903

Site Contact

Site Public Contact

401-444-1488

Medical University of South Carolina, Charleston, South Carolina

Status

Recruiting

Address

Medical University of South Carolina

Charleston, South Carolina, 29425

Site Contact

Site Public Contact

[email protected]

843-792-9321

Prisma Health Richland Hospital, Columbia, South Carolina

Status

Recruiting

Address

Prisma Health Richland Hospital

Columbia, South Carolina, 29203

Site Contact

Site Public Contact

864-241-6251

BI-LO Charities Children's Cancer Center, Greenville, South Carolina

Status

Recruiting

Address

BI-LO Charities Children's Cancer Center

Greenville, South Carolina, 29605

Site Contact

Site Public Contact

864-241-6251

East Tennessee Childrens Hospital, Knoxville, Tennessee

Status

Recruiting

Address

East Tennessee Childrens Hospital

Knoxville, Tennessee, 37916

Site Contact

Site Public Contact

865-541-8266

Saint Jude Children's Research Hospital, Memphis, Tennessee

Status

Recruiting

Address

Saint Jude Children's Research Hospital

Memphis, Tennessee, 38105

Site Contact

Site Public Contact

[email protected]

888-226-4343

Nashville, Tennessee

Status

Recruiting

Address

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232

Site Contact

Site Public Contact

800-811-8480

Austin, Texas

Status

Recruiting

Address

Dell Children's Medical Center of Central Texas

Austin, Texas, 78723

Site Contact

Site Public Contact

[email protected]

512-628-1902

Dallas, Texas

Status

Recruiting

Address

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390

Site Contact

Site Public Contact

[email protected]

214-648-7097

El Paso Children's Hospital, El Paso, Texas

Status

Recruiting

Address

El Paso Children's Hospital

El Paso, Texas, 79905

Site Contact

Site Public Contact

[email protected]

915-298-5444

Cook Children's Medical Center, Fort Worth, Texas

Status

Recruiting

Address

Cook Children's Medical Center

Fort Worth, Texas, 76104

Site Contact

Site Public Contact

[email protected]

682-885-2103

Houston, Texas

Status

Recruiting

Address

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, 77030

Site Contact

Site Public Contact

[email protected]

713-798-1354

M D Anderson Cancer Center, Houston, Texas

Status

Recruiting

Address

M D Anderson Cancer Center

Houston, Texas, 77030

Site Contact

Site Public Contact

[email protected]

877-632-6789

Covenant Children's Hospital, Lubbock, Texas

Status

Recruiting

Address

Covenant Children's Hospital

Lubbock, Texas, 79410

Site Contact

Site Public Contact

[email protected]

806-725-8657

UMC Cancer Center / UMC Health System, Lubbock, Texas

Status

Recruiting

Address

UMC Cancer Center / UMC Health System

Lubbock, Texas, 79415

Site Contact

Site Public Contact

806-775-8590

Children's Hospital of San Antonio, San Antonio, Texas

Status

Recruiting

Address

Children's Hospital of San Antonio

San Antonio, Texas, 78207

Site Contact

Site Public Contact

[email protected]

210-704-2894

San Antonio, Texas

Status

Recruiting

Address

Methodist Children's Hospital of South Texas

San Antonio, Texas, 78229

Site Contact

Site Public Contact

[email protected]

210-575-6240

San Antonio, Texas

Status

Recruiting

Address

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229

Site Contact

Site Public Contact

[email protected]

210-450-3800

Primary Children's Hospital, Salt Lake City, Utah

Status

Recruiting

Address

Primary Children's Hospital

Salt Lake City, Utah, 84113

Site Contact

Site Public Contact

801-585-5270

Burlington, Vermont

Status

Recruiting

Address

University of Vermont and State Agricultural College

Burlington, Vermont, 05405

Site Contact

Site Public Contact

[email protected]

802-656-8990

Norfolk, Virginia

Status

Recruiting

Address

Children's Hospital of The King's Daughters

Norfolk, Virginia, 23507

Site Contact

Site Public Contact

[email protected]

757-668-7243

Richmond, Virginia

Status

Recruiting

Address

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298

Site Contact

Site Public Contact

[email protected]

Carilion Children's, Roanoke, Virginia

Status

Recruiting

Address

Carilion Children's

Roanoke, Virginia, 24014

Site Contact

Site Public Contact

[email protected]

540-266-6238

Seattle Children's Hospital, Seattle, Washington

Status

Recruiting

Address

Seattle Children's Hospital

Seattle, Washington, 98105

Site Contact

Site Public Contact

866-987-2000

Spokane, Washington

Status

Recruiting

Address

Providence Sacred Heart Medical Center and Children's Hospital

Spokane, Washington, 99204

Site Contact

Site Public Contact

[email protected]

800-228-6618

Tacoma, Washington

Status

Recruiting

Address

Mary Bridge Children's Hospital and Health Center

Tacoma, Washington, 98405

Site Contact

Site Public Contact

[email protected]

253-403-1461

Madigan Army Medical Center, Tacoma, Washington

Status

Recruiting

Address

Madigan Army Medical Center

Tacoma, Washington, 98431

Site Contact

Site Public Contact

[email protected]

253-968-6144

West Virginia University Healthcare, Morgantown, West Virginia

Status

Recruiting

Address

West Virginia University Healthcare

Morgantown, West Virginia, 26506

Site Contact

Site Public Contact

[email protected]

304-293-7374

Madison, Wisconsin

Status

Recruiting

Address

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, 53792

Site Contact

Site Public Contact

[email protected]

800-622-8922

Children's Hospital of Wisconsin, Milwaukee, Wisconsin

Status

Recruiting

Address

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226

Site Contact

Site Public Contact

[email protected]

414-955-4727

International Sites

Janeway Child Health Centre, Saint John's, Newfoundland and Labrador, Canada

Status

Recruiting

Address

Janeway Child Health Centre

Saint John's, Newfoundland and Labrador, A1B 3V6

Site Contact

Site Public Contact

[email protected]

709-777-8727

IWK Health Centre, Halifax, Nova Scotia, Canada

Status

Recruiting

Address

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8

Site Contact

Site Public Contact

[email protected]

902-470-8520

Montreal, Quebec, Canada

Status

Recruiting

Address

The Montreal Children's Hospital of the MUHC

Montreal, Quebec, H3H 1P3

Site Contact

Site Public Contact

[email protected]

514-412-4445

Montreal, Quebec, Canada

Status

Suspended

Address

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, H3T 1C5

Sherbrooke, Quebec, Canada

Status

Recruiting

Address

Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

Sherbrooke, Quebec, J1H 5N4

Site Contact

Site Public Contact

[email protected]

819-820-6480

Quebec, Canada

Status

Recruiting

Address

CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)

Quebec, , G1V 4G2

Site Contact

Site Public Contact

[email protected]

418-525-4444

HIMA San Pablo Oncologic Hospital, Caguas, Puerto Rico

Status

Suspended

Address

HIMA San Pablo Oncologic Hospital

Caguas, , 00726

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