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Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)
Study Purpose
This phase III trial studies iobenguane I-131 or lorlatinib and standard therapy in treating younger patients with newly-diagnosed high-risk neuroblastoma or ganglioneuroblastoma. Radioactive drugs, such as iobenguane I-131, may carry radiation directly to tumor cells and not harm normal cells. Lorlatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving iobenguane I-131 or lorlatinib and standard therapy may work better compared to lorlatinib and standard therapy alone in treating younger patients with neuroblastoma or ganglioneuroblastoma.
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 | 365 Days - 30 Years |
| Gender | All |
Inclusion Criteria:
- - Patients must be enrolled on ANBL00B1 (NCT00904241) or APEC14B1 (NCT02402244) prior to enrollment on ANBL1531 (NCT03126916) - Patient must be >= 365 days and =< 30 years of age at diagnosis.
- - Patients must have a diagnosis of neuroblastoma or ganglioneuroblastoma (nodular) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites; the following disease groups are eligible: - Patients with International Neuroblastoma Risk Group (INRG) stage M disease are eligible if found to have either of the following features: - MYCN amplification (> 4-fold increase in MYCN signals as compared to reference signals), regardless of additional biologic features; OR.
- - Age > 547 days regardless of biologic features.
- - Patients with INRG stage MS disease with MYCN amplification.
- - Patients with INRG stage L2 disease with MYCN amplification.
- - Patients > 547 days of age initially diagnosed with INRG stage L1, L2 or MS disease who progressed to stage M without prior chemotherapy may enroll within 4 weeks of progression to stage M.
- - Patients >= 365 days of age initially diagnosed with MYCN amplified INRG stage L1 disease who progress to stage M without systemic therapy may enroll within 4 weeks of progression to stage M.
- - Patients initially recognized to have high-risk disease must have had no prior systemic therapy (other than topotecan/cyclophosphamide initiated on an emergent basis and within allowed timing); patients observed or treated with a single cycle of chemotherapy per a low or intermediate risk neuroblastoma regimen (e.g., as per ANBL0531, ANBL1232 or similar) for what initially appeared to be non-high risk disease but subsequently found to meet the criteria will also be eligible; patients who receive localized emergency radiation to sites of life-threatening or function-threatening disease prior to or immediately after establishment of the definitive diagnosis will be 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: - 1 to < 2 years: male = 0.6; female = 0.6.
- - 2 to < 6 years: male = 0.8; female = 0.8.
- - 6 to < 10 years: male = 1; female = 1.
- - 10 to < 13 years: male = 1.2; female = 1.2.
- - 13 to < 16 years: male = 1.5; female = 1.4.
- - >= 16 years: male = 1.7; female = 1.4.
- - Total bilirubin =< 1.5 x upper limit of normal (ULN) for age, and.
- - Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 10 x ULN; for the purposes of this study, ULN for SGPT (ALT) is 45.
- - Shortening fraction of >= 27% by echocardiogram, or ejection fraction of > 50% by echocardiogram or radionuclide angiogram.
- - No known contraindication to peripheral blood stem cell (PBSC) collection; examples of contraindications might be a weight or size less than the collecting institution finds feasible, or a physical condition that would limit the ability of the child to undergo apheresis catheter placement (if necessary) and/or the apheresis procedure.
Exclusion Criteria:
- - Patients with INRG stage L2 tumors without amplification of MYCN regardless of tumor histology (may meet criteria for high risk classification but are not eligible for this trial) - Patients with bone marrow failure syndromes.
- - Patients for whom targeted radiopharmaceutical therapy would be contraindicated due to underlying medical disorders.
- - Female patients who are pregnant 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.
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. |
NCT03126916 |
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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. |
Steven DuBois |
| 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, NIH |
| Overall Status | Active, not recruiting |
| Countries | Canada, Puerto Rico, United States |
|
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Ganglioneuroblastoma, Neuroblastoma |
PRIMARY OBJECTIVES:
- I. To determine in the context of a randomized trial whether the event-free survival (EFS) of patients with newly diagnosed high-risk neuroblastoma (NBL) is improved with the addition of iobenguane I-131 (131I-MIBG) during induction, prior to tandem autologous stem cell transplantation (ASCT).
- II. To determine whether the addition of lorlatinib to intensive multimodality therapy for patients with high-risk NBL whose tumors harbor activating point mutations in the ALK gene with a variant allele frequency (VAF) >= 5% results in superior EFS compared to a contemporaneously treated cohort of patients with tumors without documented ALK activating mutations.
- I. To describe the toxicities associated with treatment for high-risk NBL with and without the addition of 131I-MIBG or ALK inhibitor therapy.
- II. To estimate EFS and describe toxicity in patients with newly diagnosed high-risk NBL randomized to treatment with an 131I-MIBG-containing induction prior to busulfan/melphalan (BuMel) ASCT.
- III. To describe the overall survival (OS) and response rates (evaluated per International Neuroblastoma Response Criteria [INRC] criteria prior to ASCT and prior to post-consolidation therapy) for patients with high-risk neuroblastoma treated with or without 131I-MIBG or ALK inhibitor therapy.
- IV. To prospectively evaluate the relationship of response rate per revised International Neuroblastoma Response Criteria (INRC) to EFS and OS in patients with high-risk NBL treated with and without the addition of 131I-MIBG or ALK inhibitor therapy.
- I. To evaluate whole body radiation dose, tumor factors, and host factors as potential predictors of efficacy and/or toxicity associated with 131I-MIBG therapy and transplant conditioning.
- II. To describe end-Induction response, EFS, and OS according to specific ALK mutations, VAF, ALK amplification, the presence of additional genomic findings, or the ALK inhibitor administered.
- III. To characterize changes in tumor markers (circulating tumor deoxyribonucleic acid [DNA], including ALK and other tumor specific genetic aberrations, and circulating GD2) over time in response to protocol therapy.
- IV. To correlate results of tumor and host profiling with end-induction response and EFS.
- V. To prospectively evaluate EFS for patients with MIBG non-avid high-risk NBL compared to patients with MIBG-avid high-risk NBL who are randomized to treatment without 131I-MIBG.
- VI. To correlate Curie scores calculated from 131I-MIBG post-treatment scans with end-induction response, EFS and OS.
- VII. To describe changes in image defined risk factors (IDRFs) over the course of induction therapy, with correlation to surgical outcomes and local failure rates following primary tumor resection.
- VIII. To define patterns of failure at time of first relapse or progression in patients with high-risk NBL.
- IX. To determine the feasibility of prospectively monitoring adverse events using electronic health records.
- X. To compare local, central, and computer assisted Curie score assignment at baseline and during therapy in patients with MIBG-avid high-risk NBL.
Arms
Experimental: Arm A (chemotherapy, HSCT, EBRT)
See Arm A in detailed description.
Experimental: Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT)
See Arm B in detailed description.
Experimental: Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT)
See Arm C in detailed description. Closed to accrual as of 12/17/20.
Experimental: Arm D (chemotherapy, HSCT, EBRT)
See Arm D in detailed description.
Experimental: Arm E (lorlatinib, chemotherapy, HSCT, EBRT)
See Arm E in detailed description.
Interventions
Procedure: - Autologous Hematopoietic Stem Cell Transplantation
Undergo autologous HSCT
Procedure: - Biospecimen Collection
Undergo blood sample collection
Procedure: - Bone Marrow Aspiration and Biopsy
Undergo bone marrow aspiration and biopsy
Drug: - Busulfan
Given IV
Drug: - Carboplatin
Given IV
Drug: - Cisplatin
Given IV
Procedure: - Computed Tomography
Undergo CT scan
Drug: - Cyclophosphamide
Given IV
Drug: - Dexrazoxane Hydrochloride
Given IV
Biological: - Dinutuximab
Given IV
Drug: - Doxorubicin Hydrochloride
Given IV
Procedure: - Echocardiography
Undergo echocardiography
Drug: - Etoposide Phosphate
Given IV
Radiation: - External Beam Radiation Therapy
Undergo EBRT
Radiation: - Iobenguane I-123
Given 123 I-MIBG
Radiation: - Iobenguane I-131
Given IV
Drug: - Isotretinoin
Given PO
Drug: - Lorlatinib
Given PO
Procedure: - Magnetic Resonance Imaging
Undergo MRI
Drug: - Melphalan Hydrochloride
Given IV
Procedure: - Multigated Acquisition Scan
Undergo MUGA scan
Procedure: - Positron Emission Tomography
Undergo PET scan
Biological: - Sargramostim
Given SC
Procedure: - Therapeutic Conventional Surgery
Undergo standard of care surgery
Drug: - Thiotepa
Given IV
Drug: - Topotecan Hydrochloride
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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Address
Arkansas Children's Hospital
Little Rock, Arkansas, 72202-3591
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Address
Kaiser Permanente Downey Medical Center
Downey, California, 90242
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Address
Loma Linda University Medical Center
Loma Linda, California, 92354
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Address
Children's Hospital Los Angeles
Los Angeles, California, 90027
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Address
Mattel Children's Hospital UCLA
Los Angeles, California, 90095
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Address
Valley Children's Hospital
Madera, California, 93636
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Address
Kaiser Permanente-Oakland
Oakland, California, 94611
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Address
Children's Hospital of Orange County
Orange, California, 92868
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Address
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, 94304
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Address
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
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Address
Rady Children's Hospital - San Diego
San Diego, California, 92123
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Address
Naval Medical Center -San Diego
San Diego, California, 92134
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Address
UCSF Medical Center-Mission Bay
San Francisco, California, 94158
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Address
Children's Hospital Colorado
Aurora, Colorado, 80045
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Address
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver, Colorado, 80218
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Address
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
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Address
Yale University
New Haven, Connecticut, 06520
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Address
Alfred I duPont Hospital for Children
Wilmington, Delaware, 19803
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Address
Children's National Medical Center
Washington, District of Columbia, 20010
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Address
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, 33908
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Address
University of Florida Health Science Center - Gainesville
Gainesville, Florida, 32610
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Address
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021
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Address
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, 32207
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Address
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
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Address
Nicklaus Children's Hospital
Miami, Florida, 33155
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Address
AdventHealth Orlando
Orlando, Florida, 32803
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Address
Nemours Children's Hospital
Orlando, Florida, 32827
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Address
Johns Hopkins All Children's Hospital
Saint Petersburg, Florida, 33701
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Address
Saint Mary's Medical Center
West Palm Beach, Florida, 33407
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Address
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, 30329
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Address
Memorial Health University Medical Center
Savannah, Georgia, 31404
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Address
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
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Address
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
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Address
Lurie Children's Hospital-Chicago
Chicago, Illinois, 60611
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Address
University of Illinois
Chicago, Illinois, 60612
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Address
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
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Address
Advocate Children's Hospital-Oak Lawn
Oak Lawn, Illinois, 60453
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Address
Advocate Children's Hospital-Park Ridge
Park Ridge, Illinois, 60068
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Address
Saint Jude Midwest Affiliate
Peoria, Illinois, 61637
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Address
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
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Address
Riley Hospital for Children
Indianapolis, Indiana, 46202
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Address
Blank Children's Hospital
Des Moines, Iowa, 50309
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Address
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
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Address
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
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Address
Children's Hospital New Orleans
New Orleans, Louisiana, 70118
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Address
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
Tufts Children's Hospital
Boston, Massachusetts, 02111
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Address
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
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Address
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Status
Address
C S Mott Children's Hospital
Ann Arbor, Michigan, 48109
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Address
Children's Hospital of Michigan
Detroit, Michigan, 48201
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Address
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201
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Address
Henry Ford Health Saint John Hospital
Detroit, Michigan, 48236
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Address
Michigan State University Clinical Center
East Lansing, Michigan, 48824
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Address
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503
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Address
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
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Address
Corewell Health Children's
Royal Oak, Michigan, 48073
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Address
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, 55404
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Address
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455
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Address
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
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Address
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Status
Address
University of Missouri Children's Hospital
Columbia, Missouri, 65212
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Address
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
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Address
Washington University School of Medicine
Saint Louis, Missouri, 63110
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Address
Mercy Hospital Saint Louis
Saint Louis, Missouri, 63141
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Address
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, 68114
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Address
University of Nebraska Medical Center
Omaha, Nebraska, 68198
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Address
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102
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Address
Sunrise Hospital and Medical Center
Las Vegas, Nevada, 89109
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Address
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, 89135
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Address
Summerlin Hospital Medical Center
Las Vegas, Nevada, 89144
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Address
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
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Address
Hackensack University Medical Center
Hackensack, New Jersey, 07601
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Address
Morristown Medical Center
Morristown, New Jersey, 07960
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Address
Saint Peter's University Hospital
New Brunswick, New Jersey, 08901
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Address
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903
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Address
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
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Address
Saint Joseph's Regional Medical Center
Paterson, New Jersey, 07503
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Address
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
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Address
Albany Medical Center
Albany, New York, 12208
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Address
Montefiore Medical Center - Moses Campus
Bronx, New York, 10467
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Address
Maimonides Medical Center
Brooklyn, New York, 11219
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Address
Roswell Park Cancer Institute
Buffalo, New York, 14263
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Address
NYU Langone Hospital - Long Island
Mineola, New York, 11501
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Address
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, 11040
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Address
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016
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Address
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
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Address
University of Rochester
Rochester, New York, 14642
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Address
Stony Brook University Medical Center
Stony Brook, New York, 11794
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Address
State University of New York Upstate Medical University
Syracuse, New York, 13210
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Address
New York Medical College
Valhalla, New York, 10595
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Address
Mission Hospital
Asheville, North Carolina, 28801
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Address
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
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Address
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203
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Address
Duke University Medical Center
Durham, North Carolina, 27710
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Address
East Carolina University
Greenville, North Carolina, 27834
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Address
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
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Address
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
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Address
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
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Address
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, 44106
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Address
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
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Address
Nationwide Children's Hospital
Columbus, Ohio, 43205
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Address
Dayton Children's Hospital
Dayton, Ohio, 45404
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Address
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo, Ohio, 43606
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Address
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
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103
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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
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
Prisma Health Richland Hospital
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
East Tennessee Childrens Hospital
Knoxville, Tennessee, 37916
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Address
Saint Jude Children's Research Hospital
Memphis, Tennessee, 38105
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Address
The Children's Hospital at TriStar Centennial
Nashville, Tennessee, 37203
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Address
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
Status
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
Status
Address
Medical City Dallas Hospital
Dallas, Texas, 75230
Status
Address
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
Status
Address
El Paso Children's Hospital
El Paso, Texas, 79905
Status
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
Status
Address
Covenant Children's Hospital
Lubbock, Texas, 79410
Status
Address
UMC Cancer Center / UMC Health System
Lubbock, Texas, 79415
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Address
Children's Hospital of San Antonio
San Antonio, Texas, 78207
Status
Address
Methodist Children's Hospital of South Texas
San Antonio, Texas, 78229
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Address
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Status
Address
Primary Children's Hospital
Salt Lake City, Utah, 84113
Status
Address
University of Vermont and State Agricultural College
Burlington, Vermont, 05405
Status
Address
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
Status
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
Madigan Army Medical Center
Tacoma, Washington, 98431
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Address
West Virginia University Healthcare
Morgantown, West Virginia, 26506
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Address
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301
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Address
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792
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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
Status
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
Status
Address
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, L8N 3Z5
Status
Address
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7
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Address
Children's Hospital
London, Ontario, N6A 5W9
Status
Address
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
Status
Address
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Status
Address
HIMA San Pablo Oncologic Hospital
Caguas, , 00726
