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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 |
Inclusion Criteria:
- - Patients must be >= 2 years and =< 21 years at the time of enrollment.
- - Patients must have a body surface area (BSA) of >= 0.5 m^2 at enrollment.
- - Patients must have non-neurofibromatosis type 1 (non-NF1) low-grade glioma (LGG) without a BRAFV600E mutation as confirmed by Rapid Central Pathology and Molecular Screening Reviews performed on APEC14B1 (NCT02402244) Childhood Cancer Data Initiative (CCDI)-MCI, or accepted Clinical Laboratory Improvement Amendments (CLIA)-certified test and that has not been treated with any modality besides surgery.
- - Patients with residual tumor after resection or progressive tumor after initial diagnosis (with or without surgery) who have not received treatment (chemotherapy and/or radiation) are eligible.
- - Patients must have two-dimensional measurable tumor >= 1 cm^2 to be eligible.
- - Patients with ependymoma are not eligible.
- - Eligible histologies will include all tumors considered low-grade glioma or low-grade astrocytoma (World Health Organization [WHO] grade I and II) by 5th edition WHO classification of central nervous system (CNS) tumors with the exception of subependymal giant cell astrocytoma.
- - Patients with metastatic disease or multiple independent primary LGG are eligible.
- - Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 OR a serum creatinine based on age/sex as follows (performed within 7 days prior to enrollment): - Age: Maximum Serum Creatinine (mg/dL) - 2 to < 6 years: 0.8 mg/dL (male); 0.8 mg/dL (female) - 6 to < 10 years: 1 mg/dL (male); 1 mg/dL (female) - 10 to < 13 years: 1.2 mg/dL (male); 1.2 mg/dL (female) - 13 to < 16 years: 1.5 mg/dL (male); 1.4 mg/dL (female) - >= 16 years: 1.7 mg/dL (male); 1.4 mg/dL (female) - Total bilirubin =< 1.5 x upper limit of normal (ULN) for age (performed within 7 days prior to enrollment) (children with a diagnosis of Gilbert's syndrome will be allowed on study regardless of their total and indirect [unconjugated] bilirubin levels as long as their direct [conjugated] bilirubin is < 3.1 mg/dL) - Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L (performed within 7 days prior to enrollment).
- - Albumin >= 2 g/dL (performed within 7 days prior to enrollment) - Left ventricular ejection fraction (LVEF) >= 53% (or institutional normal; if the LVEF result is given as a range of values, then the upper value of the range will be used) by echocardiogram (performed within 4 weeks prior to enrollment) - Corrected QT (QTc) interval =< 450 msec by electrocardiography (EKG) (performed within 4 weeks prior to enrollment) - Absolute neutrophil count >= 1,000/uL (unsupported) (performed within 7 days prior to enrollment) - Platelets >= 100,000/uL (unsupported) (performed within 7 days prior to enrollment) - Hemoglobin >= 8 g/dL (may be supported) (performed within 7 days prior to enrollment) - Patients with a known seizure disorder must be stable and must not have experienced a significant increase in seizure frequency within 2 weeks prior to enrollment.
- - Patients 2-17 years of age must have a blood pressure that is =< 95th percentile for age, height, and sex at the time of enrollment (with or without the use of anti-hypertensive medications) - Patients >= 18 years of age must have a blood pressure =< 130/80 mmHg at the time of enrollment (with or without the use of anti-hypertensive medications) - Note for patients of all ages: Adequate blood pressure can be achieved using medication for the treatment of hypertension.
- - All patients must have ophthalmology toxicity assessments performed within 8 weeks prior to enrollment.
- - For all patients, 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 8 weeks prior to enrollment.
- - Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2.
- - 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.
- - 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.
- - 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.
- - 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.
- - 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.
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 |
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).
- 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.
- I. To obtain paired blood and tumor specimens for future biology studies as well as data from Molecular Characterization Initiative (MCI) testing, to correlate genomic drivers to efficacy outcomes.
Arms
Active Comparator: Arm I (vincristine sulfate, carboplatin)
INDUCTION: Patients receive vincristine sulfate IV on days 1, 8, 15, 22, 29, 36, 43, 50, 57, and 64, and carboplatin IV over 60 minutes on days 1, 8, 15, 22, 43, 50, 57, and 64 in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood and magnetic resonance imaging (MRI) at baseline and end of induction. MAINTENANCE: Patients receive vincristine sulfate IV on days 1, 8, and 15, and carboplatin IV over 60 minutes on days 1, 8, 15, and 22. 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
Undergo blood sample collection
Drug: - Carboplatin
Given IV
Procedure: - Magnetic Resonance Imaging
Undergo MRI
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.
Status
Recruiting
Address
Children's Hospital of Alabama
Birmingham 4049979, Alabama 4829764, 35233
Status
Recruiting
Address
Banner Children's at Desert
Mesa 5304391, Arizona 5551752, 85202
Status
Recruiting
Address
Phoenix Childrens Hospital
Phoenix 5308655, Arizona 5551752, 85016
Status
Recruiting
Address
Arkansas Children's Hospital
Little Rock 4119403, Arkansas 4099753, 72202-3591
Status
Recruiting
Address
Loma Linda University Medical Center
Loma Linda 5367696, California 5332921, 92354
Status
Recruiting
Address
Miller Children's and Women's Hospital Long Beach
Long Beach 5367929, California 5332921, 90806
Status
Recruiting
Address
Children's Hospital Los Angeles
Los Angeles 5368361, California 5332921, 90027
Status
Recruiting
Address
Cedars Sinai Medical Center
Los Angeles 5368361, California 5332921, 90048
Status
Recruiting
Address
Mattel Children's Hospital UCLA
Los Angeles 5368361, California 5332921, 90095
Status
Recruiting
Address
Kaiser Permanente-Oakland
Oakland 5378538, California 5332921, 94611
Status
Recruiting
Address
Children's Hospital of Orange County
Orange 5379513, California 5332921, 92868
Status
Recruiting
Address
Lucile Packard Children's Hospital Stanford University
Palo Alto 5380748, California 5332921, 94304
Status
Recruiting
Address
Rady Children's Hospital - San Diego
San Diego 5391811, California 5332921, 92123
Status
Recruiting
Address
UCSF Medical Center-Mission Bay
San Francisco 5391959, California 5332921, 94158
Status
Recruiting
Address
Children's Hospital Colorado
Aurora 5412347, Colorado 5417618, 80045
Status
Recruiting
Address
Connecticut Children's Medical Center
Hartford 4835797, Connecticut 4831725, 06106
Status
Recruiting
Address
Yale University
New Haven 4839366, Connecticut 4831725, 06520
Status
Recruiting
Address
Alfred I duPont Hospital for Children
Wilmington 4145381, Delaware 4142224, 19803
Status
Recruiting
Address
Children's National Medical Center
Washington D.C. 4140963, District of Columbia 4138106, 20010
Status
Recruiting
Address
Golisano Children's Hospital of Southwest Florida
Fort Myers 4155995, Florida 4155751, 33908
Status
Active, not recruiting
Address
University of Florida Health Science Center - Gainesville
Gainesville 4156404, Florida 4155751, 32610
Status
Recruiting
Address
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood 4158928, Florida 4155751, 33021
Status
Recruiting
Address
Nemours Children's Clinic-Jacksonville
Jacksonville 4160021, Florida 4155751, 32207
Status
Withdrawn
Address
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami 4164138, Florida 4155751, 33136
Status
Recruiting
Address
Nicklaus Children's Hospital
Miami 4164138, Florida 4155751, 33155
Status
Recruiting
Address
AdventHealth Orlando
Orlando 4167147, Florida 4155751, 32803
Status
Recruiting
Address
Arnold Palmer Hospital for Children
Orlando 4167147, Florida 4155751, 32806
Status
Recruiting
Address
Nemours Children's Hospital
Orlando 4167147, Florida 4155751, 32827
Status
Recruiting
Address
Nemours Children's Clinic - Pensacola
Pensacola 4168228, Florida 4155751, 32504
Status
Suspended
Address
Sacred Heart Hospital
Pensacola 4168228, Florida 4155751, 32504
Status
Recruiting
Address
Johns Hopkins All Children's Hospital
St. Petersburg 4171563, Florida 4155751, 33701
Status
Recruiting
Address
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa 4174757, Florida 4155751, 33607
Status
Recruiting
Address
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta 4180439, Georgia 4197000, 30329
Status
Recruiting
Address
Kapiolani Medical Center for Women and Children
Honolulu 5856195, Hawaii 5855797, 96826
Status
Recruiting
Address
Saint Luke's Cancer Institute - Boise
Boise 5586437, Idaho 5596512, 83712
Status
Recruiting
Address
Lurie Children's Hospital-Chicago
Chicago 4887398, Illinois 4896861, 60611
Status
Recruiting
Address
University of Illinois
Chicago 4887398, Illinois 4896861, 60612
Status
Recruiting
Address
University of Chicago Comprehensive Cancer Center
Chicago 4887398, Illinois 4896861, 60637
Status
Recruiting
Address
Saint Jude Midwest Affiliate
Peoria 4905687, Illinois 4896861, 61637
Status
Recruiting
Address
Southern Illinois University School of Medicine
Springfield 4250542, Illinois 4896861, 62702
Status
Recruiting
Address
Riley Hospital for Children
Indianapolis 4259418, Indiana 4921868, 46202
Status
Recruiting
Address
Ascension Saint Vincent Indianapolis Hospital
Indianapolis 4259418, Indiana 4921868, 46260
Status
Recruiting
Address
Blank Children's Hospital
Des Moines 4853828, Iowa 4862182, 50309
Status
Recruiting
Address
University of Iowa/Holden Comprehensive Cancer Center
Iowa City 4862034, Iowa 4862182, 52242
Status
Recruiting
Address
University of Kentucky/Markey Cancer Center
Lexington 4297983, Kentucky 6254925, 40536
Status
Recruiting
Address
Norton Children's Hospital
Louisville 4299276, Kentucky 6254925, 40202
Status
Recruiting
Address
Children's Hospital New Orleans
New Orleans 4335045, Louisiana 4331987, 70118
Status
Recruiting
Address
Eastern Maine Medical Center
Bangor 4957280, Maine 4971068, 04401
Status
Recruiting
Address
Maine Children's Cancer Program
Scarborough 4977882, Maine 4971068, 04074
Status
Recruiting
Address
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore 4347778, Maryland 4361885, 21287
Status
Recruiting
Address
Walter Reed National Military Medical Center
Bethesda 4348599, Maryland 4361885, 20889-5600
Status
Active, not recruiting
Address
Massachusetts General Hospital Cancer Center
Boston 4930956, Massachusetts 6254926, 02114
Status
Active, not recruiting
Address
Dana-Farber Cancer Institute
Boston 4930956, Massachusetts 6254926, 02215
Status
Recruiting
Address
C S Mott Children's Hospital
Ann Arbor 4984247, Michigan 5001836, 48109
Status
Recruiting
Address
Children's Hospital of Michigan
Detroit 4990729, Michigan 5001836, 48201
Status
Recruiting
Address
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids 4994358, Michigan 5001836, 49503
Status
Active, not recruiting
Address
Corewell Health Children's
Royal Oak 5007804, Michigan 5001836, 48073
Status
Recruiting
Address
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis 5037649, Minnesota 5037779, 55404
Status
Recruiting
Address
University of Minnesota/Masonic Cancer Center
Minneapolis 5037649, Minnesota 5037779, 55455
Status
Recruiting
Address
Mayo Clinic in Rochester
Rochester 5043473, Minnesota 5037779, 55905
Status
Recruiting
Address
University of Mississippi Medical Center
Jackson 4431410, Mississippi 4436296, 39216
Status
Recruiting
Address
Children's Mercy Hospitals and Clinics
Kansas City 4393217, Missouri 4398678, 64108
Status
Recruiting
Address
Cardinal Glennon Children's Medical Center
St Louis 4407066, Missouri 4398678, 63104
Status
Recruiting
Address
Washington University School of Medicine
St Louis 4407066, Missouri 4398678, 63110
Status
Recruiting
Address
Children's Hospital and Medical Center of Omaha
Omaha 5074472, Nebraska 5073708, 68114
Status
Recruiting
Address
University of Nebraska Medical Center
Omaha 5074472, Nebraska 5073708, 68198
Status
Recruiting
Address
Morristown Medical Center
Morristown 5101427, New Jersey 5101760, 07960
Status
Recruiting
Address
Albany Medical Center
Albany 5106834, New York 5128638, 12208
Status
Recruiting
Address
Roswell Park Cancer Institute
Buffalo 5110629, New York 5128638, 14263
Status
Recruiting
Address
NYU Langone Hospital - Long Island
Mineola 5127134, New York 5128638, 11501
Status
Recruiting
Address
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park 5128514, New York 5128638, 11040
Status
Recruiting
Address
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York 5128581, New York 5128638, 10016
Status
Recruiting
Address
Memorial Sloan Kettering Cancer Center
New York 5128581, New York 5128638, 10065
Status
Recruiting
Address
University of Rochester
Rochester 5134086, New York 5128638, 14642
Status
Recruiting
Address
State University of New York Upstate Medical University
Syracuse 5140405, New York 5128638, 13210
Status
Recruiting
Address
New York Medical College
Valhalla 5142090, New York 5128638, 10595
Status
Recruiting
Address
UNC Lineberger Comprehensive Cancer Center
Chapel Hill 4460162, North Carolina 4482348, 27599
Status
Recruiting
Address
Carolinas Medical Center/Levine Cancer Institute
Charlotte 4460243, North Carolina 4482348, 28203
Status
Recruiting
Address
Duke University Medical Center
Durham 4464368, North Carolina 4482348, 27710
Status
Recruiting
Address
East Carolina University
Greenville 4469160, North Carolina 4482348, 27834
Status
Recruiting
Address
Wake Forest University Health Sciences
Winston-Salem 4499612, North Carolina 4482348, 27157
Status
Recruiting
Address
Sanford Broadway Medical Center
Fargo 5059163, North Dakota 5690763, 58122
Status
Recruiting
Address
Children's Hospital Medical Center of Akron
Akron 5145476, Ohio 5165418, 44308
Status
Recruiting
Address
Cincinnati Children's Hospital Medical Center
Cincinnati 4508722, Ohio 5165418, 45229
Status
Recruiting
Address
Rainbow Babies and Childrens Hospital
Cleveland 5150529, Ohio 5165418, 44106
Status
Recruiting
Address
Nationwide Children's Hospital
Columbus 4509177, Ohio 5165418, 43205
Status
Recruiting
Address
Dayton Children's Hospital
Dayton 4509884, Ohio 5165418, 45404
Status
Recruiting
Address
University of Oklahoma Health Sciences Center
Oklahoma City 4544349, Oklahoma 4544379, 73104
Status
Recruiting
Address
Oregon Health and Science University
Portland 5746545, Oregon 5744337, 97239
Status
Recruiting
Address
Geisinger Medical Center
Danville 5186327, Pennsylvania 6254927, 17822
Status
Recruiting
Address
Penn State Children's Hospital
Hershey 5193342, Pennsylvania 6254927, 17033
Status
Recruiting
Address
Children's Hospital of Philadelphia
Philadelphia 4560349, Pennsylvania 6254927, 19104
Status
Recruiting
Address
Saint Christopher's Hospital for Children
Philadelphia 4560349, Pennsylvania 6254927, 19134
Status
Recruiting
Address
Children's Hospital of Pittsburgh of UPMC
Pittsburgh 5206379, Pennsylvania 6254927, 15224
Status
Recruiting
Address
Rhode Island Hospital
Providence 5224151, Rhode Island 5224323, 02903
Status
Recruiting
Address
Medical University of South Carolina
Charleston 4574324, South Carolina 4597040, 29425
Status
Recruiting
Address
Prisma Health Richland Hospital
Columbia 4575352, South Carolina 4597040, 29203
Status
Recruiting
Address
BI-LO Charities Children's Cancer Center
Greenville 4580543, South Carolina 4597040, 29605
Status
Recruiting
Address
East Tennessee Childrens Hospital
Knoxville 4634946, Tennessee 4662168, 37916
Status
Recruiting
Address
Saint Jude Children's Research Hospital
Memphis 4641239, Tennessee 4662168, 38105
Status
Recruiting
Address
Vanderbilt University/Ingram Cancer Center
Nashville 4644585, Tennessee 4662168, 37232
Status
Recruiting
Address
Dell Children's Medical Center of Central Texas
Austin 4671654, Texas 4736286, 78723
Status
Recruiting
Address
UT Southwestern/Simmons Cancer Center-Dallas
Dallas 4684888, Texas 4736286, 75390
Status
Recruiting
Address
El Paso Children's Hospital
El Paso 5520993, Texas 4736286, 79905
Status
Recruiting
Address
Cook Children's Medical Center
Fort Worth 4691930, Texas 4736286, 76104
Status
Recruiting
Address
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston 4699066, Texas 4736286, 77030
Status
Recruiting
Address
M D Anderson Cancer Center
Houston 4699066, Texas 4736286, 77030
Status
Recruiting
Address
Covenant Children's Hospital
Lubbock 5525577, Texas 4736286, 79410
Status
Recruiting
Address
UMC Cancer Center / UMC Health System
Lubbock 5525577, Texas 4736286, 79415
Status
Recruiting
Address
Children's Hospital of San Antonio
San Antonio 4726206, Texas 4736286, 78207
Status
Recruiting
Address
Methodist Children's Hospital of South Texas
San Antonio 4726206, Texas 4736286, 78229
Status
Recruiting
Address
University of Texas Health Science Center at San Antonio
San Antonio 4726206, Texas 4736286, 78229
Status
Recruiting
Address
Primary Children's Hospital
Salt Lake City 5780993, Utah 5549030, 84113
Status
Recruiting
Address
University of Vermont and State Agricultural College
Burlington 5234372, Vermont 5242283, 05405
Status
Recruiting
Address
Children's Hospital of The King's Daughters
Norfolk 4776222, Virginia 6254928, 23507
Status
Recruiting
Address
VCU Massey Comprehensive Cancer Center
Richmond 4781708, Virginia 6254928, 23298
Status
Recruiting
Address
Carilion Children's
Roanoke 4782167, Virginia 6254928, 24014
Status
Recruiting
Address
Seattle Children's Hospital
Seattle 5809844, Washington 5815135, 98105
Status
Recruiting
Address
Providence Sacred Heart Medical Center and Children's Hospital
Spokane 5811696, Washington 5815135, 99204
Status
Recruiting
Address
Mary Bridge Children's Hospital and Health Center
Tacoma 5812944, Washington 5815135, 98405
Status
Recruiting
Address
Madigan Army Medical Center
Tacoma 5812944, Washington 5815135, 98431
Status
Recruiting
Address
West Virginia University Healthcare
Morgantown 4815352, West Virginia 4826850, 26506
Status
Recruiting
Address
University of Wisconsin Carbone Cancer Center - University Hospital
Madison 5261457, Wisconsin 5279468, 53792
Status
Recruiting
Address
Children's Hospital of Wisconsin
Milwaukee 5263045, Wisconsin 5279468, 53226
International Sites
Status
Recruiting
Address
British Columbia Children's Hospital
Vancouver 6173331, British Columbia 5909050, V6H 3V4
Status
Recruiting
Address
Janeway Child Health Centre
St. John's 6324733, Newfoundland and Labrador 6354959, A1B 3V6
Status
Recruiting
Address
IWK Health Centre
Halifax 6324729, Nova Scotia 6091530, B3K 6R8
Status
Recruiting
Address
The Montreal Children's Hospital of the MUHC
Montreal 6077243, Quebec 6115047, H3H 1P3
Status
Recruiting
Address
Centre Hospitalier Universitaire Sainte-Justine
Montreal 6077243, Quebec 6115047, H3T 1C5
Status
Recruiting
Address
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Sherbrooke 6146143, Quebec 6115047, J1H 5N4
Status
Recruiting
Address
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
Québec 6325494, , G1V 4G2
Status
Active, not recruiting
Address
HIMA San Pablo Oncologic Hospital
Caguas 4563008, , 00726
