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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
|
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 | 365 Days - 30 Years |
| Gender | All |
Inclusion Criteria:
- - FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patients must be enrolled on ANBL00B1 (NCT00904241) or APEC14B1 (NCT02402244) prior to enrollment on ANBL1531 (NCT03126916) - FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patient must be >= 365 days and =< 30 years of age at diagnosis.
- - FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: 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.
- - FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: 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.
- - FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: 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.
- - FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Total bilirubin =< 1.5 x upper limit of normal (ULN) for age, and.
- - FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 10 x ULN; for the purposes of this study, ULN for SGPT (ALT) is 45.
- - FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Shortening fraction of >= 27% by echocardiogram, or ejection fraction of > 50% by echocardiogram or radionuclide angiogram.
- - FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: 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.
- - PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): See ANBL2131 (NCT06172296) protocol for eligible high-risk neuroblastoma diagnoses.
- - PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): In addition, all patients transferring from ANBL2131 (NCT06172296) to ANBL1531 (NCT03126916) Arm E must have tumors with an ALK aberration.
- - PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Given the lack of data with lorlatinib in infant populations, patients transferring from ANBL2131 (NCT06172296) to ANBL1531 (NCT03126916) must be > 1 year of age at time of transfer to ANBL1531 (NCT03126916).
- - PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients initially recognized to have high-risk disease must have received no more than one cycle of topotecan/cyclophosphamide either after enrollment to ANBL2131 (NCT06172296) or started emergently prior to enrollment to ANBL2131 (NCT06172296) - PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients may have received up to one cycle of intermediate risk chemotherapy prior to initial enrollment to ANBL2131 (NCT06172296) - PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients may have received localized emergency radiation to sites of life-threatening or function-threatening disease prior to or immediately after establishment of the definitive diagnosis.
- - PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): In order to facilitate patient transfer and ensure timely distribution of lorlatinib, there are no blood count requirements to meet at time of transfer from ANBL2131 (NCT06172296) to ANBL1531 ((NCT03126916) Arm E.
- - PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): No known irreversible grade 2 or greater atrioventricular (AV) block.
- - PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Due the potential psychiatric risks from lorlatinib, patients should not have a personal history of a serious psychiatric disorder requiring pharmacologic intervention or severe enough to be considered life-threatening.
- - PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): No known contraindication to PBSC collection.
Exclusion Criteria:
- - FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: 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) - FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patients with bone marrow failure syndromes.
- - FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patients for whom targeted radiopharmaceutical therapy would be contraindicated due to underlying medical disorders.
- - FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: 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.
- - FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Lactating females who plan to breastfeed their infants.
- - FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation.
- - PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients who have previously received treatment with lorlatinib or other ALK inhibitor.
- - PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients who have undergone treatment arm randomization callback or started induction cycle 2 on ANBL2131 (NCT06172296) - PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients who have an INRG Stage L2 tumor without amplification of MYCN regardless of tumor histology (may meet criteria for high risk classification but are not eligible for this trial) - PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients with bone marrow failure syndromes.
- - PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs.
- - PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): 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 |
|
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 |
|
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Steven G DuBois |
| 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 | Recruiting |
| Countries | Canada, Puerto Rico, United States |
|
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Ganglioneuroblastoma, Ganglioneuroblastoma, Nodular, 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 Test
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
Recruiting
Address
Children's Hospital of Alabama
Birmingham 4049979, Alabama 4829764, 35233
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
Kaiser Permanente Downey Medical Center
Downey 5343858, California 5332921, 90242
Status
Recruiting
Address
Loma Linda University Medical Center
Loma Linda 5367696, California 5332921, 92354
Status
Recruiting
Address
Children's Hospital Los Angeles
Los Angeles 5368361, California 5332921, 90027
Status
Recruiting
Address
Mattel Children's Hospital UCLA
Los Angeles 5368361, California 5332921, 90095
Status
Recruiting
Address
Valley Children's Hospital
Madera 5369568, California 5332921, 93636
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
University of California Davis Comprehensive Cancer Center
Sacramento 5389489, California 5332921, 95817
Status
Recruiting
Address
Rady Children's Hospital - San Diego
San Diego 5391811, California 5332921, 92123
Status
Recruiting
Address
Naval Medical Center -San Diego
San Diego 5391811, California 5332921, 92134
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
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver 5419384, Colorado 5417618, 80218
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
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
Recruiting
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
Nemours Children's Hospital
Orlando 4167147, Florida 4155751, 32827
Status
Recruiting
Address
Johns Hopkins All Children's Hospital
St. Petersburg 4171563, Florida 4155751, 33701
Status
Recruiting
Address
Saint Mary's Medical Center
West Palm Beach 4177887, Florida 4155751, 33407
Status
Recruiting
Address
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta 4180439, Georgia 4197000, 30329
Status
Recruiting
Address
Memorial Health University Medical Center
Savannah 4221552, Georgia 4197000, 31404
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
Advocate Children's Hospital-Oak Lawn
Oak Lawn 4904365, Illinois 4896861, 60453
Status
Recruiting
Address
Advocate Children's Hospital-Park Ridge
Park Ridge 4905367, Illinois 4896861, 60068
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
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
Children's Hospital New Orleans
New Orleans 4335045, Louisiana 4331987, 70118
Status
Recruiting
Address
Ochsner Medical Center Jefferson
New Orleans 4335045, Louisiana 4331987, 70121
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
Sinai Hospital of Baltimore
Baltimore 4347778, Maryland 4361885, 21215
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
Tufts Children's Hospital
Boston 4930956, Massachusetts 6254926, 02111
Status
Recruiting
Address
Massachusetts General Hospital Cancer Center
Boston 4930956, Massachusetts 6254926, 02114
Status
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
Active, not recruiting
Address
Wayne State University/Karmanos Cancer Institute
Detroit 4990729, Michigan 5001836, 48201
Status
Active, not recruiting
Address
Henry Ford Health Saint John Hospital
Detroit 4990729, Michigan 5001836, 48236
Status
Suspended
Address
Michigan State University
East Lansing 4991640, Michigan 5001836, 48823
Status
Recruiting
Address
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids 4994358, Michigan 5001836, 49503
Status
Recruiting
Address
Bronson Methodist Hospital
Kalamazoo 4997787, Michigan 5001836, 49007
Status
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
University of Missouri Children's Hospital
Columbia 4381982, Missouri 4398678, 65212
Status
Recruiting
Address
Children's Mercy Hospitals and Clinics
Kansas City 4393217, Missouri 4398678, 64108
Status
Recruiting
Address
Washington University School of Medicine
St Louis 4407066, Missouri 4398678, 63110
Status
Recruiting
Address
Mercy Hospital Saint Louis
St Louis 4407066, Missouri 4398678, 63141
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
University Medical Center of Southern Nevada
Las Vegas 5506956, Nevada 5509151, 89102
Status
Recruiting
Address
Sunrise Hospital and Medical Center
Las Vegas 5506956, Nevada 5509151, 89109
Status
Recruiting
Address
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas 5506956, Nevada 5509151, 89135
Status
Recruiting
Address
Summerlin Hospital Medical Center
Las Vegas 5506956, Nevada 5509151, 89144
Status
Recruiting
Address
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon 5088597, New Hampshire 5090174, 03756
Status
Recruiting
Address
Hackensack University Medical Center
Hackensack 5098706, New Jersey 5101760, 07601
Status
Recruiting
Address
Morristown Medical Center
Morristown 5101427, New Jersey 5101760, 07960
Status
Recruiting
Address
Saint Peter's University Hospital
New Brunswick 5101717, New Jersey 5101760, 08901
Status
Recruiting
Address
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick 5101717, New Jersey 5101760, 08903
Status
Recruiting
Address
Newark Beth Israel Medical Center
Newark 5101798, New Jersey 5101760, 07112
Status
Recruiting
Address
Saint Joseph's Regional Medical Center
Paterson 5102466, New Jersey 5101760, 07503
Status
Recruiting
Address
University of New Mexico Cancer Center
Albuquerque 5454711, New Mexico 5481136, 87106
Status
Recruiting
Address
Albany Medical Center
Albany 5106834, New York 5128638, 12208
Status
Recruiting
Address
Maimonides Medical Center
Brooklyn 5110302, New York 5128638, 11219
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
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York 5128581, New York 5128638, 10032
Status
Recruiting
Address
University of Rochester
Rochester 5134086, New York 5128638, 14642
Status
Recruiting
Address
Stony Brook University Medical Center
Stony Brook 5139865, New York 5128638, 11794
Status
Recruiting
Address
State University of New York Upstate Medical University
Syracuse 5140405, New York 5128638, 13210
Status
Recruiting
Address
Montefiore Medical Center - Moses Campus
The Bronx 5110266, New York 5128638, 10467
Status
Recruiting
Address
New York Medical College
Valhalla 5142090, New York 5128638, 10595
Status
Recruiting
Address
Mission Hospital
Asheville 4453066, North Carolina 4482348, 28801
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
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
Cleveland Clinic Foundation
Cleveland 5150529, Ohio 5165418, 44195
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
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo 5174035, Ohio 5165418, 43606
Status
Recruiting
Address
University of Oklahoma Health Sciences Center
Oklahoma City 4544349, Oklahoma 4544379, 73104
Status
Recruiting
Address
Legacy Emanuel Children's Hospital
Portland 5746545, Oregon 5744337, 97227
Status
Recruiting
Address
Lehigh Valley Hospital-Cedar Crest
Allentown 5178127, Pennsylvania 6254927, 18103
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
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
Sanford USD Medical Center - Sioux Falls
Sioux Falls 5231851, South Dakota 5769223, 57117-5134
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
The Children's Hospital at TriStar Centennial
Nashville 4644585, Tennessee 4662168, 37203
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
Driscoll Children's Hospital
Corpus Christi 4683416, Texas 4736286, 78411
Status
Active, not recruiting
Address
Medical City Dallas Hospital
Dallas 4684888, Texas 4736286, 75230
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
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
VCU Massey Comprehensive Cancer Center
Richmond 4781708, Virginia 6254928, 23298
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
Saint Vincent Hospital Cancer Center Green Bay
Green Bay 5254962, Wisconsin 5279468, 54301
Status
Recruiting
Address
University of Wisconsin Carbone Cancer Center - University Hospital
Madison 5261457, Wisconsin 5279468, 53792
Status
Suspended
Address
Marshfield Medical Center-Marshfield
Marshfield 5261969, Wisconsin 5279468, 54449
Status
Recruiting
Address
Children's Hospital of Wisconsin
Milwaukee 5263045, Wisconsin 5279468, 53226
International Sites
Status
Suspended
Address
British Columbia Children's Hospital
Vancouver 6173331, British Columbia 5909050, V6H 3V4
Status
Suspended
Address
CancerCare Manitoba
Winnipeg 6183235, Manitoba 6065171, R3E 0V9
Status
Suspended
Address
Janeway Child Health Centre
St. John's 6324733, Newfoundland and Labrador 6354959, A1B 3V6
Status
Suspended
Address
IWK Health Centre
Halifax 6324729, Nova Scotia 6091530, B3K 6R8
Status
Suspended
Address
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton 5969782, Ontario 6093943, L8N 3Z5
Status
Suspended
Address
Kingston Health Sciences Centre
Kingston 5992500, Ontario 6093943, K7L 2V7
Status
Suspended
Address
Children's Hospital
London 6058560, Ontario 6093943, N6A 5W9
Status
Suspended
Address
Children's Hospital of Eastern Ontario
Ottawa 6094817, Ontario 6093943, K1H 8L1
Status
Suspended
Address
Hospital for Sick Children
Toronto 6167865, Ontario 6093943, M5G 1X8
Status
Active, not recruiting
Address
HIMA San Pablo Oncologic Hospital
Caguas 4563008, , 00726
