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A Study to See if Memantine Protects the Brain During Radiation Therapy Treatment for a Brain Tumor
Study Purpose
This phase III trial compares memantine to placebo in treating patients with primary central nervous system tumors. Memantine may block receptors (parts of nerve cells) in the brain known to contribute to a decline in cognitive function. Giving memantine may make a difference in cognitive function (attention, memory, or other thought processes) in children and adolescents receiving brain radiation therapy to treat a primary central nervous system tumors.
Recruitment Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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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 | 4 Years - 17 Years |
| Gender | All |
Inclusion Criteria:
- - >= 4 and < 18 years at time of study entry.
- - Patients must weigh 15 kg or greater at time of study entry.
- - Primary central nervous system tumors that have not received prior cranial radiotherapy.
- - Planned focal, cranial or craniospinal radiation treatment for a primary central nervous system tumor.
- - The patient must have receptive and expressive language skills in English, French or Spanish since the neurocognitive function and quality of life (QOL) assessment instruments are available in these languages only.
- - 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: - Age: 4 to < 6 years; Maximum serum creatinine (mg/dL): 0.8 male; 0.8 female.
- - Age: 6 to < 10 years; Maximum serum creatinine (mg/dL): 1 male; 1 female.
- - Age: 10 to < 13 years; Maximum serum creatinine (mg/dL): 1.2 male; 1.2 female.
- - Age: 13 to < 16 years; Maximum serum creatinine (mg/dL): 1.5 male; 1.4 female.
- - Age: >= 16 years; Maximum serum creatinine (mg/dL): 1.7 male; 1.4 female.
- - Total bilirubin =< 1.5 x upper limit of normal (ULN) for age.
- - Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L.
- - Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L.
- - The patient must be able to undergo magnetic resonance imaging.
- - All patients and/or their parents or legal guardians must sign a written informed consent.
- - All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.
Exclusion Criteria:
- - Life expectancy of less than 18 months.
- - Pre-existing conditions: - Any contraindication or allergy to study drug (memantine or placebo) - Intractable seizures while on adequate anticonvulsant therapy, defined as more than one seizure per month for the past 2 months or since initiating anticonvulsant therapy.
- - History of neurodevelopmental disorder such as Down syndrome, Fragile X, William's Syndrome, intellectual disability (presumed intelligence quotient [IQ] < 70), etc.
- - Co-morbid systemic illnesses, psychiatric conditions, social situations, or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens or would limit compliance with the study requirements.
- - Patients with a motor, visual, or auditory condition that precludes participation in computerized neurocognitive assessments.
- - Patients with any medical condition or taking medications that lead to alterations of urine pH towards the alkaline condition (e.g., renal tubular acidosis, carbonic anhydrase inhibitors, sodium bicarbonate) - Personal history of prior cranial or craniospinal radiotherapy is not allowed.
- - Note: Prior anti-cancer therapy including surgery, chemotherapy, targeted agents are allowed as per standard of care clinical treatment guidelines.
- - Female patients who are pregnant are excluded since fetal toxicities and teratogenic effects have been noted for the study drug.
- - Lactating females who plan to breastfeed their infants.
Trial Details
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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. |
NCT04939597 |
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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 |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Children's Oncology Group |
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Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Nadia N Laack |
| Principal Investigator Affiliation | Children's Oncology Group |
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Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
| Overall Status | Active, not recruiting |
| Countries | Puerto Rico, United States |
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Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Central Nervous System Carcinoma |
PRIMARY OBJECTIVE:
- I. To determine the efficacy, as measured by the slope of change of the Cogstate composite Z score from baseline to 12 months, of oral memantine hydrochloride (memantine) administered for a period of 6 months, when compared to placebo, in children ages 4-18 receiving cranial or craniospinal radiotherapy for primary central nervous system tumors.
- I. To determine if memantine is associated with improved cognitive function as measured for participants in the optional Children's Oncology Group (COG) Standardized Battery at 12 months.
- II. To determine if memantine is associated with change in cognitive function versus (vs.#46;) placebo as measured by Cogstate composite score at end of radiation therapy (RT), 3 and 6 months.
- III. To determine if memantine is associated with differences in cognitive function vs.#46; placebo as measured by Cogstate composite score at 24 and 48 months for participants in the optional COG Standardized Battery.
- IV. To correlate early cognitive changes (end of RT, 3, 6, 12 months Cogstate composite score) with late cognitive function (24 and 48 months Cogstate composite score).
- V. To correlate COG Standardized Battery scores to Cogstate composite scores at 12, 24, and 48 months.
- VI. To estimate the 36-month disease-free and overall survival (of primary brain tumor) after memantine treatment compared to placebo.
- VII. To correlate changes in quantitative volumetric magnetic resonance imaging (MRI) measurements of critical brain regions with cognitive function over time.
- VIII. To evaluate impact of memantine versus placebo on molecular biomarkers associated with cognitive decline after radiotherapy.
- IX. To determine whether oral memantine, when compared to placebo, is associated with reduction in the incidence of decline of composite Cogstate score at 12 months in children ages 4-18 receiving cranial radiotherapy for primary central nervous system tumors.
Arms
Experimental: Arm I (memantine hydrochloride)
Patients receive memantine hydrochloride orally PO QD for week 1 and then BID for weeks 2-24 in the absence of disease progression or unacceptable toxicity. Patients also complete cognitive testing over 20-30 minutes at baseline, end of radiation therapy, and at 3, 6, 12, 24, and 48 months. Patients undergo MRI and may optionally undergo blood sample collection throughout the trial.
Placebo Comparator: Arm II (placebo)
Patients receive placebo PO QD for week 1 and then BID for weeks 2-24 in the absence of disease progression or unacceptable toxicity. Patients also complete cognitive testing over 20-30 minutes at baseline, end of radiation therapy, and at 3, 6, 12, 24, and 48 months. Patients undergo MRI and may optionally undergo blood sample collection throughout the trial.
Interventions
Procedure: - Biospecimen Collection
Undergo blood sample collection
Procedure: - Cognitive Assessment
Complete cognitive testing
Procedure: - Magnetic Resonance Imaging
Undergo MRI
Drug: - Memantine Hydrochloride
Given PO
Drug: - Placebo Administration
Given PO
Other: - Questionnaire Administration
Ancillary studies
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
Address
Children's Hospital of Alabama
Birmingham 4049979, Alabama 4829764, 35233
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Providence Alaska Medical Center
Anchorage 5879400, Alaska 5879092, 99508
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Address
Banner Children's at Desert
Mesa 5304391, Arizona 5551752, 85202
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Phoenix Childrens Hospital
Phoenix 5308655, Arizona 5551752, 85016
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Address
Banner University Medical Center - Tucson
Tucson 5318313, Arizona 5551752, 85719
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Address
Arkansas Children's Hospital
Little Rock 4119403, Arkansas 4099753, 72202-3591
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Address
Kaiser Permanente Downey Medical Center
Downey 5343858, California 5332921, 90242
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Address
Loma Linda University Medical Center
Loma Linda 5367696, California 5332921, 92354
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Address
Miller Children's and Women's Hospital Long Beach
Long Beach 5367929, California 5332921, 90806
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Address
Children's Hospital Los Angeles
Los Angeles 5368361, California 5332921, 90027
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Address
Valley Children's Hospital
Madera 5369568, California 5332921, 93636
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Address
UCSF Benioff Children's Hospital Oakland
Oakland 5378538, California 5332921, 94609
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Address
Kaiser Permanente-Oakland
Oakland 5378538, California 5332921, 94611
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Address
Children's Hospital of Orange County
Orange 5379513, California 5332921, 92868
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Address
Lucile Packard Children's Hospital Stanford University
Palo Alto 5380748, California 5332921, 94304
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Address
Rady Children's Hospital - San Diego
San Diego 5391811, California 5332921, 92123
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Address
UCSF Medical Center-Mission Bay
San Francisco 5391959, California 5332921, 94158
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Address
Children's Hospital Colorado
Aurora 5412347, Colorado 5417618, 80045
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Address
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver 5419384, Colorado 5417618, 80218
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Address
Connecticut Children's Medical Center
Hartford 4835797, Connecticut 4831725, 06106
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Address
Alfred I duPont Hospital for Children
Wilmington 4145381, Delaware 4142224, 19803
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Address
Children's National Medical Center
Washington D.C. 4140963, District of Columbia 4138106, 20010
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Address
Golisano Children's Hospital of Southwest Florida
Fort Myers 4155995, Florida 4155751, 33908
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Address
University of Florida Health Science Center - Gainesville
Gainesville 4156404, Florida 4155751, 32610
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Address
Nemours Children's Clinic-Jacksonville
Jacksonville 4160021, Florida 4155751, 32207
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Address
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami 4164138, Florida 4155751, 33136
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Address
Nicklaus Children's Hospital
Miami 4164138, Florida 4155751, 33155
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Address
Miami Cancer Institute
Miami 4164138, Florida 4155751, 33176
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Address
AdventHealth Orlando
Orlando 4167147, Florida 4155751, 32803
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Address
Nemours Children's Hospital
Orlando 4167147, Florida 4155751, 32827
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Address
Johns Hopkins All Children's Hospital
St. Petersburg 4171563, Florida 4155751, 33701
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Address
Tampa General Hospital
Tampa 4174757, Florida 4155751, 33606
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Address
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa 4174757, Florida 4155751, 33607
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Address
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta 4180439, Georgia 4197000, 30329
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Address
Kapiolani Medical Center for Women and Children
Honolulu 5856195, Hawaii 5855797, 96826
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Address
Saint Luke's Cancer Institute - Boise
Boise 5586437, Idaho 5596512, 83712
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Address
University of Illinois
Chicago 4887398, Illinois 4896861, 60612
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University of Chicago Comprehensive Cancer Center
Chicago 4887398, Illinois 4896861, 60637
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Address
Loyola University Medical Center
Maywood 4901514, Illinois 4896861, 60153
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Address
Saint Jude Midwest Affiliate
Peoria 4905687, Illinois 4896861, 61637
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Address
Riley Hospital for Children
Indianapolis 4259418, Indiana 4921868, 46202
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Address
Blank Children's Hospital
Des Moines 4853828, Iowa 4862182, 50309
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Address
University of Iowa/Holden Comprehensive Cancer Center
Iowa City 4862034, Iowa 4862182, 52242
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Address
Norton Children's Hospital
Louisville 4299276, Kentucky 6254925, 40202
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Address
Children's Hospital New Orleans
New Orleans 4335045, Louisiana 4331987, 70118
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Ochsner Medical Center Jefferson
New Orleans 4335045, Louisiana 4331987, 70121
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Address
Maine Children's Cancer Program
Scarborough 4977882, Maine 4971068, 04074
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Address
Sinai Hospital of Baltimore
Baltimore 4347778, Maryland 4361885, 21215
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Address
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore 4347778, Maryland 4361885, 21287
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Address
Walter Reed National Military Medical Center
Bethesda 4348599, Maryland 4361885, 20889-5600
Status
Address
Massachusetts General Hospital Cancer Center
Boston 4930956, Massachusetts 6254926, 02114
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Address
Dana-Farber Cancer Institute
Boston 4930956, Massachusetts 6254926, 02215
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Address
C S Mott Children's Hospital
Ann Arbor 4984247, Michigan 5001836, 48109
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Address
Children's Hospital of Michigan
Detroit 4990729, Michigan 5001836, 48201
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Address
Michigan State University
East Lansing 4991640, Michigan 5001836, 48823
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Address
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids 4994358, Michigan 5001836, 49503
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Address
Corewell Health Children's
Royal Oak 5007804, Michigan 5001836, 48073
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Address
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis 5037649, Minnesota 5037779, 55404
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Address
Mayo Clinic in Rochester
Rochester 5043473, Minnesota 5037779, 55905
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Address
University of Mississippi Medical Center
Jackson 4431410, Mississippi 4436296, 39216
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Address
University of Missouri Children's Hospital
Columbia 4381982, Missouri 4398678, 65212
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Address
Children's Mercy Hospitals and Clinics
Kansas City 4393217, Missouri 4398678, 64108
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Address
Cardinal Glennon Children's Medical Center
St Louis 4407066, Missouri 4398678, 63104
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Address
Washington University School of Medicine
St Louis 4407066, Missouri 4398678, 63110
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Address
Mercy Hospital Saint Louis
St Louis 4407066, Missouri 4398678, 63141
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Address
Children's Hospital and Medical Center of Omaha
Omaha 5074472, Nebraska 5073708, 68114
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Address
University of Nebraska Medical Center
Omaha 5074472, Nebraska 5073708, 68198
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Address
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas 5506956, Nevada 5509151, 89135
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Address
Summerlin Hospital Medical Center
Las Vegas 5506956, Nevada 5509151, 89144
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Address
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon 5088597, New Hampshire 5090174, 03756
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Address
Hackensack University Medical Center
Hackensack 5098706, New Jersey 5101760, 07601
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Address
Morristown Medical Center
Morristown 5101427, New Jersey 5101760, 07960
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Address
Saint Peter's University Hospital
New Brunswick 5101717, New Jersey 5101760, 08901
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Address
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick 5101717, New Jersey 5101760, 08903
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Address
Saint Joseph's Regional Medical Center
Paterson 5102466, New Jersey 5101760, 07503
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Address
Albany Medical Center
Albany 5106834, New York 5128638, 12208
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Address
Maimonides Medical Center
Brooklyn 5110302, New York 5128638, 11219
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Address
Roswell Park Cancer Institute
Buffalo 5110629, New York 5128638, 14263
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Address
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park 5128514, New York 5128638, 11040
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Address
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York 5128581, New York 5128638, 10016
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Mount Sinai Hospital
New York 5128581, New York 5128638, 10029
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Address
Memorial Sloan Kettering Cancer Center
New York 5128581, New York 5128638, 10065
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Address
Stony Brook University Medical Center
Stony Brook 5139865, New York 5128638, 11794
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Address
State University of New York Upstate Medical University
Syracuse 5140405, New York 5128638, 13210
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Address
Montefiore Medical Center - Moses Campus
The Bronx 5110266, New York 5128638, 10467
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Address
Mission Hospital
Asheville 4453066, North Carolina 4482348, 28801
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Address
UNC Lineberger Comprehensive Cancer Center
Chapel Hill 4460162, North Carolina 4482348, 27599
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Address
Carolinas Medical Center/Levine Cancer Institute
Charlotte 4460243, North Carolina 4482348, 28203
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Duke University Medical Center
Durham 4464368, North Carolina 4482348, 27710
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Address
East Carolina University
Greenville 4469160, North Carolina 4482348, 27834
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Address
Wake Forest University Health Sciences
Winston-Salem 4499612, North Carolina 4482348, 27157
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Address
Sanford Broadway Medical Center
Fargo 5059163, North Dakota 5690763, 58122
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Address
Children's Hospital Medical Center of Akron
Akron 5145476, Ohio 5165418, 44308
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Address
Cincinnati Children's Hospital Medical Center
Cincinnati 4508722, Ohio 5165418, 45229
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Address
Rainbow Babies and Childrens Hospital
Cleveland 5150529, Ohio 5165418, 44106
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Address
Cleveland Clinic Foundation
Cleveland 5150529, Ohio 5165418, 44195
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Address
Nationwide Children's Hospital
Columbus 4509177, Ohio 5165418, 43205
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Address
Dayton Children's Hospital
Dayton 4509884, Ohio 5165418, 45404
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Address
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo 5174035, Ohio 5165418, 43606
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Address
University of Oklahoma Health Sciences Center
Oklahoma City 4544349, Oklahoma 4544379, 73104
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Address
Legacy Emanuel Children's Hospital
Portland 5746545, Oregon 5744337, 97227
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Address
Oregon Health and Science University
Portland 5746545, Oregon 5744337, 97239
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Address
Lehigh Valley Hospital-Cedar Crest
Allentown 5178127, Pennsylvania 6254927, 18103
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Address
Geisinger Medical Center
Danville 5186327, Pennsylvania 6254927, 17822
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Address
Children's Hospital of Philadelphia
Philadelphia 4560349, Pennsylvania 6254927, 19104
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Address
Saint Christopher's Hospital for Children
Philadelphia 4560349, Pennsylvania 6254927, 19134
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Address
Children's Hospital of Pittsburgh of UPMC
Pittsburgh 5206379, Pennsylvania 6254927, 15224
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Address
Rhode Island Hospital
Providence 5224151, Rhode Island 5224323, 02903
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Address
Prisma Health Richland Hospital
Columbia 4575352, South Carolina 4597040, 29203
Status
Address
BI-LO Charities Children's Cancer Center
Greenville 4580543, South Carolina 4597040, 29605
Status
Address
Sanford USD Medical Center - Sioux Falls
Sioux Falls 5231851, South Dakota 5769223, 57117-5134
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Address
East Tennessee Childrens Hospital
Knoxville 4634946, Tennessee 4662168, 37916
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Address
Saint Jude Children's Research Hospital
Memphis 4641239, Tennessee 4662168, 38105
Status
Address
The Children's Hospital at TriStar Centennial
Nashville 4644585, Tennessee 4662168, 37203
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Address
Vanderbilt University/Ingram Cancer Center
Nashville 4644585, Tennessee 4662168, 37232
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Address
Dell Children's Medical Center of Central Texas
Austin 4671654, Texas 4736286, 78723
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Address
Medical City Dallas Hospital
Dallas 4684888, Texas 4736286, 75230
Status
Address
UT Southwestern/Simmons Cancer Center-Dallas
Dallas 4684888, Texas 4736286, 75390
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Address
El Paso Children's Hospital
El Paso 5520993, Texas 4736286, 79905
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Address
Cook Children's Medical Center
Fort Worth 4691930, Texas 4736286, 76104
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Address
M D Anderson Cancer Center
Houston 4699066, Texas 4736286, 77030
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Address
Children's Hospital of San Antonio
San Antonio 4726206, Texas 4736286, 78207
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Address
Methodist Children's Hospital of South Texas
San Antonio 4726206, Texas 4736286, 78229
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Address
University of Texas Health Science Center at San Antonio
San Antonio 4726206, Texas 4736286, 78229
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Address
Primary Children's Hospital
Salt Lake City 5780993, Utah 5549030, 84113
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Address
University of Virginia Cancer Center
Charlottesville 4752031, Virginia 6254928, 22908
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Address
Children's Hospital of The King's Daughters
Norfolk 4776222, Virginia 6254928, 23507
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Address
VCU Massey Comprehensive Cancer Center
Richmond 4781708, Virginia 6254928, 23298
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Address
Carilion Children's
Roanoke 4782167, Virginia 6254928, 24014
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Address
Seattle Children's Hospital
Seattle 5809844, Washington 5815135, 98105
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Address
Providence Sacred Heart Medical Center and Children's Hospital
Spokane 5811696, Washington 5815135, 99204
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Address
Mary Bridge Children's Hospital and Health Center
Tacoma 5812944, Washington 5815135, 98405
Status
Address
Madigan Army Medical Center
Tacoma 5812944, Washington 5815135, 98431
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Address
West Virginia University Healthcare
Morgantown 4815352, West Virginia 4826850, 26506
Status
Address
University of Wisconsin Carbone Cancer Center - University Hospital
Madison 5261457, Wisconsin 5279468, 53792
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Address
Marshfield Medical Center-Marshfield
Marshfield 5261969, Wisconsin 5279468, 54449
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Address
Children's Hospital of Wisconsin
Milwaukee 5263045, Wisconsin 5279468, 53226
International Sites
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Address
HIMA San Pablo Oncologic Hospital
Caguas 4563008, , 00726
