Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed, Non-metastatic Desmoplastic Medulloblastoma
Study Purpose
This phase II trial studies how well combination chemotherapy works in treating younger patients with newly diagnosed, non-metastatic desmoplastic medulloblastoma. Drugs used in chemotherapy, such as vincristine sulfate, cyclophosphamide, methotrexate, etoposide, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
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 | N/A - 47 Months |
Gender | All |
Inclusion Criteria:
- - Patients must be newly diagnosed and have a confirmed histologic diagnosis of nodular desmoplastic (ND) medulloblastoma or medulloblastoma with extensive nodularity (MBEN) from rapid central pathology screening review; please note: patients with Gorlin syndrome are eligible.
- - Patient must have negative lumbar cerebrospinal fluid (CSF) cytology (lumbar CSF must be obtained unless medically contraindicated); CSF cytology for staging should be performed preferably no sooner than 14 days post operatively to avoid false positive CSF, ideally, CSF should be obtained between day 14 and day 21 to allow for final staging status before enrollment onto the study; Note: patients with positive CSF cytology obtained prior to 14 days after surgery may have cytology repeated to determine eligibility and final CSF status.
- - Patients must have: - Pre-operative cranial magnetic resonance imaging (MRI) (recommended with gadolinium) or pre-operative computed tomography (CT) (recommended with contrast) - Post-operative cranial MRI with and without gadolinium within 72 hours of surgery.
- - Spinal MRI pre-op with and without gadolinium or post-op with and without gadolinium preferably within 72 hours of surgery.
- - Patients must be enrolled on study within 31 days of definitive surgical resection at which time tissue is acquired to determine a diagnosis; patients must be enrolled before treatment begins; the date protocol therapy is projected to start must be no later than five (5) calendar days after the date of study enrollment; patients who are started on protocol therapy on a Phase II study prior to study enrollment will be considered ineligible.
- - Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2; use Lansky for patients =< 16 years of age.
- - Patients must have a life expectancy of >= 8 weeks.
- - Patients who are receiving dexamethasone must be on a stable dose for at least 1 week prior to study entry.
- - Peripheral absolute neutrophil count (ANC) >= 1000/uL.
- - Platelet count >= 100,000/uL (transfusion independent) - Hemoglobin >= 10.0 g/dL (may receive red blood cell [RBC] transfusions) - 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: - 1 month to < 6 months: 0.4 mg/dL.
- - 6 months to < 1 year: 0.5 mg/dL.
- - 1 to < 2 years: 0.6 mg/dL.
- - 2 to < 6 years: 0.8 mg/dL.
- - Total bilirubin =< 1.5 x upper limit of normal (ULN) for age.
- - Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x upper limit of normal (ULN) for age.
- - Central nervous system function defined as: - Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled.
- - Patients must not be in status, coma or assisted ventilation prior to study enrollment.
Exclusion Criteria:
- - Patients with metastatic disease by either MRI evaluation (brain and spine) or lumbar CSF cytology 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. |
NCT02017964 |
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 2 |
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 |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Lucie E Lafay-Cousin |
Principal Investigator Affiliation | Children's Oncology Group |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other, NIH |
Overall Status | Active, not recruiting |
Countries | Australia, Canada, Puerto Rico, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Desmoplastic/Nodular Medulloblastoma, Medulloblastoma, Medulloblastoma With Extensive Nodularity, Nevoid Basal Cell Carcinoma Syndrome, Untreated Childhood Medulloblastoma |
PRIMARY OBJECTIVES:
- I. Estimate of the progression free survival (PFS) distribution for patients 0-<4 years of age with M0 desmoplastic medulloblastoma (nodular desmoplastic or medulloblastoma with extensive nodularity) treated with the modified HIT SKK regimen (excluding the use of intraventricular methotrexate).
- I. Evaluate the feasibility of a rapid central pathology screening review for treatment allocation according to histology and assess agreement between institutional and central pathology review diagnoses as well as among central pathology review diagnoses.
- II. Prospectively evaluate the molecular profile of nodular desmoplastic (ND)/medulloblastoma with extensive nodularity (MBEN) medulloblastoma in young children.
- III. Monitor and describe the neurocognitive and adaptive functioning of young children with ND/MBEN medulloblastoma treated on this protocol using the ALTE07C1 protocol.
Arms
Experimental: Treatment (combination chemotherapy)
INDUCTION THERAPY: Patients receive vincristine sulfate IV over 1 minute or infused via minibag on days 1, 15, and 29; cyclophosphamide IV over 1 hour on days 1-3; methotrexate IV over 24 hours on days 15 and 29; etoposide IV over 60-120 minutes on days 43-45; and carboplatin IV over 1 hour on days 43-45. Treatment repeats every 63 days for 3 courses in the absence of disease progression or unacceptable toxicity. CONTINUATION THERAPY: Patients receive vincristine sulfate IV over 1 minute or infused via minibag on day 1, cyclophosphamide IV over 1 hour on days 1-3, etoposide IV over 60-120 minutes on days 21-23, and carboplatin IV over 1 hour on days 21-23. Treatment repeats every 42 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Interventions
Drug: - Carboplatin
Given IV
Other: - Cognitive Assessment
Optional ancillary studies
Drug: - Cyclophosphamide
Given IV
Drug: - Etoposide
Given IV
Other: - Laboratory Biomarker Analysis
Correlative studies
Drug: - Methotrexate
Given IV
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
Address
Children's Hospital of Alabama
Birmingham, Alabama, 35233
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Phoenix Childrens Hospital
Phoenix, Arizona, 85016
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The University of Arizona Medical Center-University Campus
Tucson, Arizona, 85724
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Arkansas Children's Hospital
Little Rock, Arkansas, 72202-3591
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Kaiser Permanente Downey Medical Center
Downey, California, 90242
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City of Hope Comprehensive Cancer Center
Duarte, California, 91010
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Loma Linda University Medical Center
Loma Linda, California, 92354
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Miller Children's and Women's Hospital Long Beach
Long Beach, California, 90806
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Children's Hospital Los Angeles
Los Angeles, California, 90027
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Valley Children's Hospital
Madera, California, 93636
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Children's Hospital and Research Center at Oakland
Oakland, California, 94609-1809
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Kaiser Permanente-Oakland
Oakland, California, 94611
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Children's Hospital of Orange County
Orange, California, 92868
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Sutter Medical Center Sacramento
Sacramento, California, 95816
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University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
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Rady Children's Hospital - San Diego
San Diego, California, 92123
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UCSF Medical Center-Parnassus
San Francisco, California, 94143
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UCSF Medical Center-Mission Bay
San Francisco, California, 94158
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Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, 90502
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Children's Hospital Colorado
Aurora, Colorado, 80045
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Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver, Colorado, 80218
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Connecticut Children's Medical Center
Hartford, Connecticut, 06106
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Yale University
New Haven, Connecticut, 06520
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Alfred I duPont Hospital for Children
Wilmington, Delaware, 19803
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MedStar Georgetown University Hospital
Washington, District of Columbia, 20007
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Children's National Medical Center
Washington, District of Columbia, 20010
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Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, 33908
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University of Florida Health Science Center - Gainesville
Gainesville, Florida, 32610
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Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021
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Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, 32207
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University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
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Nicklaus Children's Hospital
Miami, Florida, 33155
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Florida Hospital Orlando
Orlando, Florida, 32803
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Arnold Palmer Hospital for Children
Orlando, Florida, 32806
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Address
UF Cancer Center at Orlando Health
Orlando, Florida, 32806
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Nemours Children's Hospital
Orlando, Florida, 32827
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Nemours Children's Clinic - Pensacola
Pensacola, Florida, 32504
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Johns Hopkins All Children's Hospital
Saint Petersburg, Florida, 33701
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Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, 33607
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Saint Mary's Hospital
West Palm Beach, Florida, 33407
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Address
Children's Healthcare of Atlanta - Egleston
Atlanta, Georgia, 30322
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Address
Augusta University Medical Center
Augusta, Georgia, 30912
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Memorial Health University Medical Center
Savannah, Georgia, 31404
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Address
Saint Luke's Mountain States Tumor Institute
Boise, Idaho, 83712
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Address
Lurie Children's Hospital-Chicago
Chicago, Illinois, 60611
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University of Illinois
Chicago, Illinois, 60612
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University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
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Loyola University Medical Center
Maywood, Illinois, 60153
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Advocate Children's Hospital-Oak Lawn
Oak Lawn, Illinois, 60453
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Advocate Children's Hospital-Park Ridge
Park Ridge, Illinois, 60068
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Saint Jude Midwest Affiliate
Peoria, Illinois, 61637
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Southern Illinois University School of Medicine
Springfield, Illinois, 62702
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Riley Hospital for Children
Indianapolis, Indiana, 46202
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Saint Vincent Hospital and Health Care Center
Indianapolis, Indiana, 46260
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Blank Children's Hospital
Des Moines, Iowa, 50309
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University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
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University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
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Norton Children's Hospital
Louisville, Kentucky, 40202
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Address
Children's Hospital New Orleans
New Orleans, Louisiana, 70118
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Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121
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Address
Eastern Maine Medical Center
Bangor, Maine, 04401
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Address
Maine Children's Cancer Program
Scarborough, Maine, 04074
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Address
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
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Address
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
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Address
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600
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Address
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
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Address
C S Mott Children's Hospital
Ann Arbor, Michigan, 48109
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Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201
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Ascension Saint John Hospital
Detroit, Michigan, 48236
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Address
Michigan State University Clinical Center
East Lansing, Michigan, 48824-7016
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Hurley Medical Center
Flint, Michigan, 48503
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Address
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan, 49503
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Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
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Address
Beaumont Children's Hospital-Royal Oak
Royal Oak, Michigan, 48073
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Address
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, 55404
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University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455
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Mayo Clinic
Rochester, Minnesota, 55905
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University of Mississippi Medical Center
Jackson, Mississippi, 39216
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Columbia Regional
Columbia, Missouri, 65201
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Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
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Cardinal Glennon Children's Medical Center
Saint Louis, Missouri, 63104
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Washington University School of Medicine
Saint Louis, Missouri, 63110
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Mercy Hospital Saint Louis
Saint Louis, Missouri, 63141
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Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, 68114
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University of Nebraska Medical Center
Omaha, Nebraska, 68198
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Sunrise Hospital and Medical Center
Las Vegas, Nevada, 89109
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Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, 89135
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Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
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Hackensack University Medical Center
Hackensack, New Jersey, 07601
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Morristown Medical Center
Morristown, New Jersey, 07960
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Saint Peter's University Hospital
New Brunswick, New Jersey, 08901
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Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903
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Newark Beth Israel Medical Center
Newark, New Jersey, 07112
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Saint Joseph's Regional Medical Center
Paterson, New Jersey, 07503
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University of New Mexico Cancer Center
Albuquerque, New Mexico, 87102
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Albany Medical Center
Albany, New York, 12208
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Montefiore Medical Center - Moses Campus
Bronx, New York, 10467
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Roswell Park Cancer Institute
Buffalo, New York, 14263
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NYU Winthrop Hospital
Mineola, New York, 11501
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The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, 11040
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Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016
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Mount Sinai Hospital
New York, New York, 10029
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Columbia University/Herbert Irving Cancer Center
New York, New York, 10032
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065
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University of Rochester
Rochester, New York, 14642
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State University of New York Upstate Medical University
Syracuse, New York, 13210
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New York Medical College
Valhalla, New York, 10595
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Mission Hospital Inc-Memorial Campus
Asheville, North Carolina, 28801
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UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
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Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
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Sanford Broadway Medical Center
Fargo, North Dakota, 58122
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Children's Hospital Medical Center of Akron
Akron, Ohio, 44308
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
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Rainbow Babies and Childrens Hospital
Cleveland, Ohio, 44106
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Cleveland Clinic Foundation
Cleveland, Ohio, 44195
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Address
Nationwide Children's Hospital
Columbus, Ohio, 43205
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Dayton Children's Hospital
Dayton, Ohio, 45404
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Address
The Toledo Hospital/Toledo Children's Hospital
Toledo, Ohio, 43606
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University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
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Address
Legacy Emanuel Children's Hospital
Portland, Oregon, 97227
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Address
Oregon Health and Science University
Portland, Oregon, 97239
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Address
Geisinger Medical Center
Danville, Pennsylvania, 17822
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Address
Penn State Children's Hospital
Hershey, Pennsylvania, 17033
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Address
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
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Address
Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134
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Address
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
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Address
Rhode Island Hospital
Providence, Rhode Island, 02903
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Address
Medical University of South Carolina
Charleston, South Carolina, 29425
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Address
Palmetto Health Richland
Columbia, South Carolina, 29203
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Address
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, 29605
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Address
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
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Address
T C Thompson Children's Hospital
Chattanooga, Tennessee, 37403
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Address
East Tennessee Childrens Hospital
Knoxville, Tennessee, 37916
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Address
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
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Address
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
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Address
Dell Children's Medical Center of Central Texas
Austin, Texas, 78723
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Address
Driscoll Children's Hospital
Corpus Christi, Texas, 78411
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Address
Medical City Dallas Hospital
Dallas, Texas, 75230
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Address
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
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Address
El Paso Children's Hospital
El Paso, Texas, 79905
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Address
Cook Children's Medical Center
Fort Worth, Texas, 76104
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Address
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77030
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Children's Hospital of San Antonio
San Antonio, Texas, 78207
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Address
Methodist Children's Hospital of South Texas
San Antonio, Texas, 78229
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University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
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Scott and White Memorial Hospital
Temple, Texas, 76508
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Address
Primary Children's Hospital
Salt Lake City, Utah, 84113
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Address
University of Vermont College of Medicine
Burlington, Vermont, 05405
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Address
Inova Fairfax Hospital
Falls Church, Virginia, 22042
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Address
Children's Hospital of The King's Daughters
Norfolk, Virginia, 23507
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Address
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
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Address
Carilion Clinic Children's Hospital
Roanoke, Virginia, 24014
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Address
Seattle Children's Hospital
Seattle, Washington, 98105
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Address
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, 99204
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Address
Mary Bridge Children's Hospital and Health Center
Tacoma, Washington, 98405
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Address
West Virginia University Healthcare
Morgantown, West Virginia, 26506
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Address
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
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Address
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
International Sites
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John Hunter Children's Hospital
Hunter Regional Mail Centre, New South Wales, 2310
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Address
Women's and Children's Hospital-Adelaide
North Adelaide, South Australia, 5006
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Address
Princess Margaret Hospital for Children
Perth, Western Australia, 6008
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Address
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
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Address
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4
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Address
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
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Address
Janeway Child Health Centre
Saint John's, Newfoundland and Labrador, A1B 3V6
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Address
IWK Health Centre
Halifax, Nova Scotia, B3K 6R8
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Address
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, L8N 3Z5
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Address
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Status
Address
The Montreal Children's Hospital of the MUHC
Montreal, Quebec, H3H 1P3
Status
Address
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, H3T 1C5
Status
Address
Centre Hospitalier Universitaire de Quebec
Quebec, , G1V 4G2
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Address
San Jorge Children's Hospital
San Juan, , 00912
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Address
University Pediatric Hospital
San Juan, , 00926