Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)

Phase 3

Active, not recruiting

Conditions: Ganglioneuroblastoma
Neuroblastoma

Registration Number: NCT03126916

Lead Sponsor: Children's Oncology Group

Brief Summary: 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 o...

Detailed Description: 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).
...

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: All

Target Recruitment: 724

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
Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT)	Etoposide Phosphate	See Arm C in detailed description. Closed to accrual as of 12/17/20.
Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT)	Melphalan Hydrochloride	See Arm C in detailed description. Closed to accrual as of 12/17/20.
Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT)	Autologous Hematopoietic Stem Cell Transplantation	See Arm B in detailed description.
Arm A (chemotherapy, HSCT, EBRT)	Doxorubicin Hydrochloride	See Arm A in detailed description.
Arm A (chemotherapy, HSCT, EBRT)	Iobenguane I-123	See Arm A in detailed description.
Arm A (chemotherapy, HSCT, EBRT)	Biospecimen Collection	See Arm A in detailed description.
Arm A (chemotherapy, HSCT, EBRT)	Carboplatin	See Arm A in detailed description.
Arm A (chemotherapy, HSCT, EBRT)	Dexrazoxane Hydrochloride	See Arm A in detailed description.
Arm A (chemotherapy, HSCT, EBRT)	Multigated Acquisition Scan	See Arm A in detailed description.
Arm A (chemotherapy, HSCT, EBRT)	Positron Emission Tomography	See Arm A in detailed description.
Arm A (chemotherapy, HSCT, EBRT)	Computed Tomography	See Arm A in detailed description.
Arm A (chemotherapy, HSCT, EBRT)	Isotretinoin	See Arm A in detailed description.
Arm A (chemotherapy, HSCT, EBRT)	Therapeutic Conventional Surgery	See Arm A in detailed description.
Arm A (chemotherapy, HSCT, EBRT)	Autologous Hematopoietic Stem Cell Transplantation	See Arm A in detailed description.
Arm A (chemotherapy, HSCT, EBRT)	Cisplatin	See Arm A in detailed description.
Arm A (chemotherapy, HSCT, EBRT)	Cyclophosphamide	See Arm A in detailed description.
Arm A (chemotherapy, HSCT, EBRT)	Dinutuximab	See Arm A in detailed description.
Arm A (chemotherapy, HSCT, EBRT)	Bone Marrow Aspiration and Biopsy	See Arm A in detailed description.
Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT)	Vincristine Sulfate	See Arm C in detailed description. Closed to accrual as of 12/17/20.
Arm A (chemotherapy, HSCT, EBRT)	Echocardiography	See Arm A in detailed description.
Arm A (chemotherapy, HSCT, EBRT)	Etoposide Phosphate	See Arm A in detailed description.
Arm A (chemotherapy, HSCT, EBRT)	External Beam Radiation Therapy	See Arm A in detailed description.
Arm A (chemotherapy, HSCT, EBRT)	Sargramostim	See Arm A in detailed description.
Arm A (chemotherapy, HSCT, EBRT)	Vincristine Sulfate	See Arm A in detailed description.
Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT)	Biospecimen Collection	See Arm B in detailed description.
Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT)	Cisplatin	See Arm B in detailed description.
Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT)	Computed Tomography	See Arm B in detailed description.
Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT)	Dexrazoxane Hydrochloride	See Arm B in detailed description.
Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT)	Echocardiography	See Arm B in detailed description.
Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT)	External Beam Radiation Therapy	See Arm B in detailed description.
Arm A (chemotherapy, HSCT, EBRT)	Topotecan Hydrochloride	See Arm A in detailed description.
Arm A (chemotherapy, HSCT, EBRT)	Thiotepa	See Arm A in detailed description.
Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT)	Iobenguane I-123	See Arm B in detailed description.
Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT)	Bone Marrow Aspiration and Biopsy	See Arm B in detailed description.
Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT)	Magnetic Resonance Imaging	See Arm B in detailed description.
Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT)	Topotecan Hydrochloride	See Arm B in detailed description.
Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT)	Doxorubicin Hydrochloride	See Arm C in detailed description. Closed to accrual as of 12/17/20.
Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT)	Isotretinoin	See Arm C in detailed description. Closed to accrual as of 12/17/20.
Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT)	Positron Emission Tomography	See Arm C in detailed description. Closed to accrual as of 12/17/20.
Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT)	Carboplatin	See Arm B in detailed description.
Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT)	Cyclophosphamide	See Arm B in detailed description.
Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT)	Dinutuximab	See Arm B in detailed description.
Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT)	Doxorubicin Hydrochloride	See Arm B in detailed description.
Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT)	Etoposide Phosphate	See Arm B in detailed description.
Arm D (chemotherapy, HSCT, EBRT)	Biospecimen Collection	See Arm D in detailed description.
Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT)	Bone Marrow Aspiration and Biopsy	See Arm C in detailed description. Closed to accrual as of 12/17/20.
Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT)	Cyclophosphamide	See Arm C in detailed description. Closed to accrual as of 12/17/20.
Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT)	Dexrazoxane Hydrochloride	See Arm C in detailed description. Closed to accrual as of 12/17/20.
Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT)	External Beam Radiation Therapy	See Arm C in detailed description. Closed to accrual as of 12/17/20.
Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT)	Therapeutic Conventional Surgery	See Arm C in detailed description. Closed to accrual as of 12/17/20.
Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT)	Iobenguane I-131	See Arm B in detailed description.
Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT)	Multigated Acquisition Scan	See Arm B in detailed description.
Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT)	Vincristine Sulfate	See Arm B in detailed description.
Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT)	Autologous Hematopoietic Stem Cell Transplantation	See Arm C in detailed description. Closed to accrual as of 12/17/20.
Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT)	Cisplatin	See Arm C in detailed description. Closed to accrual as of 12/17/20.
Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT)	Computed Tomography	See Arm C in detailed description. Closed to accrual as of 12/17/20.
Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT)	Dinutuximab	See Arm C in detailed description. Closed to accrual as of 12/17/20.
Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT)	Echocardiography	See Arm C in detailed description. Closed to accrual as of 12/17/20.
Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT)	Sargramostim	See Arm B in detailed description.
Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT)	Therapeutic Conventional Surgery	See Arm B in detailed description.
Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT)	Thiotepa	See Arm B in detailed description.
Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT)	Magnetic Resonance Imaging	See Arm C in detailed description. Closed to accrual as of 12/17/20.
Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT)	Sargramostim	See Arm C in detailed description. Closed to accrual as of 12/17/20.
Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT)	Isotretinoin	See Arm B in detailed description.
Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT)	Positron Emission Tomography	See Arm B in detailed description.
Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT)	Biospecimen Collection	See Arm C in detailed description. Closed to accrual as of 12/17/20.
Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT)	Busulfan	See Arm C in detailed description. Closed to accrual as of 12/17/20.
Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT)	Iobenguane I-131	See Arm C in detailed description. Closed to accrual as of 12/17/20.
Arm D (chemotherapy, HSCT, EBRT)	Therapeutic Conventional Surgery	See Arm D in detailed description.
Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT)	Topotecan Hydrochloride	See Arm C in detailed description. Closed to accrual as of 12/17/20.
Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT)	Multigated Acquisition Scan	See Arm C in detailed description. Closed to accrual as of 12/17/20.
Arm D (chemotherapy, HSCT, EBRT)	Dinutuximab	See Arm D in detailed description.
Arm D (chemotherapy, HSCT, EBRT)	Bone Marrow Aspiration and Biopsy	See Arm D in detailed description.
Arm D (chemotherapy, HSCT, EBRT)	Computed Tomography	See Arm D in detailed description.
Arm D (chemotherapy, HSCT, EBRT)	Iobenguane I-123	See Arm D in detailed description.
Arm D (chemotherapy, HSCT, EBRT)	Positron Emission Tomography	See Arm D in detailed description.
Arm D (chemotherapy, HSCT, EBRT)	Autologous Hematopoietic Stem Cell Transplantation	See Arm D in detailed description.
Arm D (chemotherapy, HSCT, EBRT)	External Beam Radiation Therapy	See Arm D in detailed description.
Arm D (chemotherapy, HSCT, EBRT)	Isotretinoin	See Arm D in detailed description.
Arm D (chemotherapy, HSCT, EBRT)	Sargramostim	See Arm D in detailed description.
Arm D (chemotherapy, HSCT, EBRT)	Vincristine Sulfate	See Arm D in detailed description.
Arm E (lorlatinib, chemotherapy, HSCT, EBRT)	Autologous Hematopoietic Stem Cell Transplantation	See Arm E in detailed description.
Arm E (lorlatinib, chemotherapy, HSCT, EBRT)	Bone Marrow Aspiration and Biopsy	See Arm E in detailed description.
Arm E (lorlatinib, chemotherapy, HSCT, EBRT)	Iobenguane I-123	See Arm E in detailed description.
Arm D (chemotherapy, HSCT, EBRT)	Multigated Acquisition Scan	See Arm D in detailed description.
Arm D (chemotherapy, HSCT, EBRT)	Topotecan Hydrochloride	See Arm D in detailed description.
Arm E (lorlatinib, chemotherapy, HSCT, EBRT)	Echocardiography	See Arm E in detailed description.
Arm E (lorlatinib, chemotherapy, HSCT, EBRT)	Etoposide Phosphate	See Arm E in detailed description.
Arm E (lorlatinib, chemotherapy, HSCT, EBRT)	Therapeutic Conventional Surgery	See Arm E in detailed description.
Arm D (chemotherapy, HSCT, EBRT)	Carboplatin	See Arm D in detailed description.
Arm D (chemotherapy, HSCT, EBRT)	Dexrazoxane Hydrochloride	See Arm D in detailed description.
Arm D (chemotherapy, HSCT, EBRT)	Doxorubicin Hydrochloride	See Arm D in detailed description.
Arm D (chemotherapy, HSCT, EBRT)	Etoposide Phosphate	See Arm D in detailed description.
Arm D (chemotherapy, HSCT, EBRT)	Magnetic Resonance Imaging	See Arm D in detailed description.
Arm E (lorlatinib, chemotherapy, HSCT, EBRT)	Computed Tomography	See Arm E in detailed description.
Arm E (lorlatinib, chemotherapy, HSCT, EBRT)	Biospecimen Collection	See Arm E in detailed description.
Arm E (lorlatinib, chemotherapy, HSCT, EBRT)	Sargramostim	See Arm E in detailed description.
Arm E (lorlatinib, chemotherapy, HSCT, EBRT)	Thiotepa	See Arm E in detailed description.
Arm E (lorlatinib, chemotherapy, HSCT, EBRT)	Dexrazoxane Hydrochloride	See Arm E in detailed description.
Arm E (lorlatinib, chemotherapy, HSCT, EBRT)	Dinutuximab	See Arm E in detailed description.
Arm E (lorlatinib, chemotherapy, HSCT, EBRT)	External Beam Radiation Therapy	See Arm E in detailed description.
Arm E (lorlatinib, chemotherapy, HSCT, EBRT)	Multigated Acquisition Scan	See Arm E in detailed description.
Arm E (lorlatinib, chemotherapy, HSCT, EBRT)	Positron Emission Tomography	See Arm E in detailed description.
Arm E (lorlatinib, chemotherapy, HSCT, EBRT)	Topotecan Hydrochloride	See Arm E in detailed description.
Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT)	Thiotepa	See Arm C in detailed description. Closed to accrual as of 12/17/20.
Arm D (chemotherapy, HSCT, EBRT)	Cisplatin	See Arm D in detailed description.
Arm D (chemotherapy, HSCT, EBRT)	Cyclophosphamide	See Arm D in detailed description.
Arm D (chemotherapy, HSCT, EBRT)	Thiotepa	See Arm D in detailed description.
Arm E (lorlatinib, chemotherapy, HSCT, EBRT)	Carboplatin	See Arm E in detailed description.
Arm E (lorlatinib, chemotherapy, HSCT, EBRT)	Cisplatin	See Arm E in detailed description.
Arm E (lorlatinib, chemotherapy, HSCT, EBRT)	Cyclophosphamide	See Arm E in detailed description.
Arm E (lorlatinib, chemotherapy, HSCT, EBRT)	Doxorubicin Hydrochloride	See Arm E in detailed description.
Arm E (lorlatinib, chemotherapy, HSCT, EBRT)	Isotretinoin	See Arm E in detailed description.
Arm E (lorlatinib, chemotherapy, HSCT, EBRT)	Lorlatinib	See Arm E in detailed description.

Primary Outcome Measures

Name	Time	Method
Event free survival (EFS) (Arm A, B, D, and E)	3 years	EFS time is calculated from date of randomization or assignment to first episode of disease relapse or progression, second malignancy, or death, or until last contact if no event has occurred.

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events	Up to 18 months for Arms A-D and 28 months for Arm E	The proportion of patients with at least one Grade 3 or higher toxicity during protocol therapy, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0, will be reported.
Overall survival (OS)	3 years	OS time is calculated from date of randomization or assignment until death, or until last contact if patient is alive.
Response rate	Up to 6 months	The response rate will be calculated among all evaluable patients at end-Induction. Responders are defined as patients who achieve a \>= partial response (PR) per the revised International Neuroblastoma Response Criteria (INRC).
EFS (Arm C)	3 years	EFS time is calculated from date of randomization to first episode of disease relapse or progression, second malignancy, or death, or until last contact if no event has occurred.

Trial Locations

Locations (161): Children's Healthcare of Atlanta - Arthur M Blank Hospital
🇺🇸
Atlanta, Georgia, United States
Henry Ford Health Saint John Hospital
🇺🇸
Detroit, Michigan, United States
Children's Hospital of Alabama
🇺🇸
Birmingham, Alabama, United States
Phoenix Childrens Hospital
🇺🇸
Phoenix, Arizona, United States
Arkansas Children's Hospital
🇺🇸
Little Rock, Arkansas, United States
Kaiser Permanente Downey Medical Center
🇺🇸
Downey, California, United States
Loma Linda University Medical Center
🇺🇸
Loma Linda, California, United States
Children's Hospital Los Angeles
🇺🇸
Los Angeles, California, United States
Mattel Children's Hospital UCLA
🇺🇸
Los Angeles, California, United States
Valley Children's Hospital
🇺🇸
Madera, California, United States
Kaiser Permanente-Oakland
🇺🇸
Oakland, California, United States
Children's Hospital of Orange County
🇺🇸
Orange, California, United States
Lucile Packard Children's Hospital Stanford University
🇺🇸
Palo Alto, California, United States
University of California Davis Comprehensive Cancer Center
🇺🇸
Sacramento, California, United States
Rady Children's Hospital - San Diego
🇺🇸
San Diego, California, United States
Naval Medical Center -San Diego
🇺🇸
San Diego, California, United States
UCSF Medical Center-Mission Bay
🇺🇸
San Francisco, California, United States
Children's Hospital Colorado
🇺🇸
Aurora, Colorado, United States
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
🇺🇸
Denver, Colorado, United States
Connecticut Children's Medical Center
🇺🇸
Hartford, Connecticut, United States
Yale University
🇺🇸
New Haven, Connecticut, United States
Alfred I duPont Hospital for Children
🇺🇸
Wilmington, Delaware, United States
Children's National Medical Center
🇺🇸
Washington, District of Columbia, United States
Golisano Children's Hospital of Southwest Florida
🇺🇸
Fort Myers, Florida, United States
University of Florida Health Science Center - Gainesville
🇺🇸
Gainesville, Florida, United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
🇺🇸
Hollywood, Florida, United States
Nemours Children's Clinic-Jacksonville
🇺🇸
Jacksonville, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
🇺🇸
Miami, Florida, United States
Nicklaus Children's Hospital
🇺🇸
Miami, Florida, United States
AdventHealth Orlando
🇺🇸
Orlando, Florida, United States
Nemours Children's Hospital
🇺🇸
Orlando, Florida, United States
Johns Hopkins All Children's Hospital
🇺🇸
Saint Petersburg, Florida, United States
Saint Mary's Hospital
🇺🇸
West Palm Beach, Florida, United States
Memorial Health University Medical Center
🇺🇸
Savannah, Georgia, United States
Kapiolani Medical Center for Women and Children
🇺🇸
Honolulu, Hawaii, United States
Saint Luke's Cancer Institute - Boise
🇺🇸
Boise, Idaho, United States
Lurie Children's Hospital-Chicago
🇺🇸
Chicago, Illinois, United States
University of Illinois
🇺🇸
Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center
🇺🇸
Chicago, Illinois, United States
Advocate Children's Hospital-Oak Lawn
🇺🇸
Oak Lawn, Illinois, United States
Advocate Children's Hospital-Park Ridge
🇺🇸
Park Ridge, Illinois, United States
Saint Jude Midwest Affiliate
🇺🇸
Peoria, Illinois, United States
Southern Illinois University School of Medicine
🇺🇸
Springfield, Illinois, United States
Riley Hospital for Children
🇺🇸
Indianapolis, Indiana, United States
Blank Children's Hospital
🇺🇸
Des Moines, Iowa, United States
University of Iowa/Holden Comprehensive Cancer Center
🇺🇸
Iowa City, Iowa, United States
University of Kentucky/Markey Cancer Center
🇺🇸
Lexington, Kentucky, United States
Children's Hospital New Orleans
🇺🇸
New Orleans, Louisiana, United States
Ochsner Medical Center Jefferson
🇺🇸
New Orleans, Louisiana, United States
Eastern Maine Medical Center
🇺🇸
Bangor, Maine, United States
Maine Children's Cancer Program
🇺🇸
Scarborough, Maine, United States
Sinai Hospital of Baltimore
🇺🇸
Baltimore, Maryland, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
🇺🇸
Baltimore, Maryland, United States
Walter Reed National Military Medical Center
🇺🇸
Bethesda, Maryland, United States
Tufts Children's Hospital
🇺🇸
Boston, Massachusetts, United States
Massachusetts General Hospital Cancer Center
🇺🇸
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
🇺🇸
Boston, Massachusetts, United States
C S Mott Children's Hospital
🇺🇸
Ann Arbor, Michigan, United States
Children's Hospital of Michigan
🇺🇸
Detroit, Michigan, United States
Wayne State University/Karmanos Cancer Institute
🇺🇸
Detroit, Michigan, United States
Michigan State University Clinical Center
🇺🇸
East Lansing, Michigan, United States
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
🇺🇸
Grand Rapids, Michigan, United States
Bronson Methodist Hospital
🇺🇸
Kalamazoo, Michigan, United States
Corewell Health Children's
🇺🇸
Royal Oak, Michigan, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
🇺🇸
Minneapolis, Minnesota, United States
University of Minnesota/Masonic Cancer Center
🇺🇸
Minneapolis, Minnesota, United States
Mayo Clinic in Rochester
🇺🇸
Rochester, Minnesota, United States
University of Mississippi Medical Center
🇺🇸
Jackson, Mississippi, United States
University of Missouri Children's Hospital
🇺🇸
Columbia, Missouri, United States
Children's Mercy Hospitals and Clinics
🇺🇸
Kansas City, Missouri, United States
Washington University School of Medicine
🇺🇸
Saint Louis, Missouri, United States
Mercy Hospital Saint Louis
🇺🇸
Saint Louis, Missouri, United States
Children's Hospital and Medical Center of Omaha
🇺🇸
Omaha, Nebraska, United States
University of Nebraska Medical Center
🇺🇸
Omaha, Nebraska, United States
University Medical Center of Southern Nevada
🇺🇸
Las Vegas, Nevada, United States
Sunrise Hospital and Medical Center
🇺🇸
Las Vegas, Nevada, United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
🇺🇸
Las Vegas, Nevada, United States
Summerlin Hospital Medical Center
🇺🇸
Las Vegas, Nevada, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
🇺🇸
Lebanon, New Hampshire, United States
Hackensack University Medical Center
🇺🇸
Hackensack, New Jersey, United States
Morristown Medical Center
🇺🇸
Morristown, New Jersey, United States
Saint Peter's University Hospital
🇺🇸
New Brunswick, New Jersey, United States
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
🇺🇸
New Brunswick, New Jersey, United States
Newark Beth Israel Medical Center
🇺🇸
Newark, New Jersey, United States
Saint Joseph's Regional Medical Center
🇺🇸
Paterson, New Jersey, United States
University of New Mexico Cancer Center
🇺🇸
Albuquerque, New Mexico, United States
Albany Medical Center
🇺🇸
Albany, New York, United States
Montefiore Medical Center - Moses Campus
🇺🇸
Bronx, New York, United States
Maimonides Medical Center
🇺🇸
Brooklyn, New York, United States
Roswell Park Cancer Institute
🇺🇸
Buffalo, New York, United States
NYU Langone Hospital - Long Island
🇺🇸
Mineola, New York, United States
The Steven and Alexandra Cohen Children's Medical Center of New York
🇺🇸
New Hyde Park, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
🇺🇸
New York, New York, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
🇺🇸
New York, New York, United States
University of Rochester
🇺🇸
Rochester, New York, United States
Stony Brook University Medical Center
🇺🇸
Stony Brook, New York, United States
State University of New York Upstate Medical University
🇺🇸
Syracuse, New York, United States
New York Medical College
🇺🇸
Valhalla, New York, United States
Mission Hospital
🇺🇸
Asheville, North Carolina, United States
UNC Lineberger Comprehensive Cancer Center
🇺🇸
Chapel Hill, North Carolina, United States
Carolinas Medical Center/Levine Cancer Institute
🇺🇸
Charlotte, North Carolina, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
East Carolina University
🇺🇸
Greenville, North Carolina, United States
Wake Forest University Health Sciences
🇺🇸
Winston-Salem, North Carolina, United States
Sanford Broadway Medical Center
🇺🇸
Fargo, North Dakota, United States
Cincinnati Children's Hospital Medical Center
🇺🇸
Cincinnati, Ohio, United States
Rainbow Babies and Childrens Hospital
🇺🇸
Cleveland, Ohio, United States
Cleveland Clinic Foundation
🇺🇸
Cleveland, Ohio, United States
Nationwide Children's Hospital
🇺🇸
Columbus, Ohio, United States
Dayton Children's Hospital
🇺🇸
Dayton, Ohio, United States
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
🇺🇸
Toledo, Ohio, United States
University of Oklahoma Health Sciences Center
🇺🇸
Oklahoma City, Oklahoma, United States
Legacy Emanuel Children's Hospital
🇺🇸
Portland, Oregon, United States
Lehigh Valley Hospital-Cedar Crest
🇺🇸
Allentown, Pennsylvania, United States
Geisinger Medical Center
🇺🇸
Danville, Pennsylvania, United States
Penn State Children's Hospital
🇺🇸
Hershey, Pennsylvania, United States
Children's Hospital of Philadelphia
🇺🇸
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC
🇺🇸
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
🇺🇸
Providence, Rhode Island, United States
Medical University of South Carolina
🇺🇸
Charleston, South Carolina, United States
Prisma Health Richland Hospital
🇺🇸
Columbia, South Carolina, United States
BI-LO Charities Children's Cancer Center
🇺🇸
Greenville, South Carolina, United States
Sanford USD Medical Center - Sioux Falls
🇺🇸
Sioux Falls, South Dakota, United States
East Tennessee Childrens Hospital
🇺🇸
Knoxville, Tennessee, United States
Saint Jude Children's Research Hospital
🇺🇸
Memphis, Tennessee, United States
The Children's Hospital at TriStar Centennial
🇺🇸
Nashville, Tennessee, United States
Vanderbilt University/Ingram Cancer Center
🇺🇸
Nashville, Tennessee, United States
Dell Children's Medical Center of Central Texas
🇺🇸
Austin, Texas, United States
Driscoll Children's Hospital
🇺🇸
Corpus Christi, Texas, United States
Medical City Dallas Hospital
🇺🇸
Dallas, Texas, United States
UT Southwestern/Simmons Cancer Center-Dallas
🇺🇸
Dallas, Texas, United States
El Paso Children's Hospital
🇺🇸
El Paso, Texas, United States
Cook Children's Medical Center
🇺🇸
Fort Worth, Texas, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
🇺🇸
Houston, Texas, United States
Covenant Children's Hospital
🇺🇸
Lubbock, Texas, United States
UMC Cancer Center / UMC Health System
🇺🇸
Lubbock, Texas, United States
Children's Hospital of San Antonio
🇺🇸
San Antonio, Texas, United States
Methodist Children's Hospital of South Texas
🇺🇸
San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio
🇺🇸
San Antonio, Texas, United States
Primary Children's Hospital
🇺🇸
Salt Lake City, Utah, United States
University of Vermont and State Agricultural College
🇺🇸
Burlington, Vermont, United States
Virginia Commonwealth University/Massey Cancer Center
🇺🇸
Richmond, Virginia, United States
Seattle Children's Hospital
🇺🇸
Seattle, Washington, United States
Providence Sacred Heart Medical Center and Children's Hospital
🇺🇸
Spokane, Washington, United States
Mary Bridge Children's Hospital and Health Center
🇺🇸
Tacoma, Washington, United States
Madigan Army Medical Center
🇺🇸
Tacoma, Washington, United States
West Virginia University Healthcare
🇺🇸
Morgantown, West Virginia, United States
Saint Vincent Hospital Cancer Center Green Bay
🇺🇸
Green Bay, Wisconsin, United States
University of Wisconsin Carbone Cancer Center - University Hospital
🇺🇸
Madison, Wisconsin, United States
Marshfield Medical Center-Marshfield
🇺🇸
Marshfield, Wisconsin, United States
Children's Hospital of Wisconsin
🇺🇸
Milwaukee, Wisconsin, United States
British Columbia Children's Hospital
🇨🇦
Vancouver, British Columbia, Canada
CancerCare Manitoba
🇨🇦
Winnipeg, Manitoba, Canada
Janeway Child Health Centre
🇨🇦
Saint John's, Newfoundland and Labrador, Canada
IWK Health Centre
🇨🇦
Halifax, Nova Scotia, Canada
McMaster Children's Hospital at Hamilton Health Sciences
🇨🇦
Hamilton, Ontario, Canada
Kingston Health Sciences Centre
🇨🇦
Kingston, Ontario, Canada
Children's Hospital
🇨🇦
London, Ontario, Canada
Children's Hospital of Eastern Ontario
🇨🇦
Ottawa, Ontario, Canada
Hospital for Sick Children
🇨🇦
Toronto, Ontario, Canada
HIMA San Pablo Oncologic Hospital
🇵🇷
Caguas, Puerto Rico

Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)

Recruitment & Eligibility

Study & Design

Trial Locations

Instant Trial Alerts

Instant Trial Alerts