A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or ALK Inhibitor Therapy Added to Intensive Therapy for Children With Newly Diagnosed High-Risk Neuroblastoma (NBL)

Who is this study for? Patients with Neuroblastoma, Ganglioneuroblastoma
Status: Recruiting
Location: See all (161) locations...
Intervention Type: Drug, Procedure, Biological, Radiation
Study Type: Interventional
Study Phase: Phase 3
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 30
Healthy Volunteers: f
View:

• 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

⁃ \>= 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 \< 1 year of age found to have a qualifying ALK alteration as part of ANBL2131 (NCT06172296) may continue to participate in ANBL2131 (NCT06172296)

• 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. Note the blood count criteria that must be met prior to start of Induction cycle 2 on Arm E. Lorlatinib therapy should start no sooner than day 1 of Induction cycle 2

• 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. Examples of contraindications might be a weight or size less than the collecting institution deems 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

Locations
United States
Alabama
Children's Hospital of Alabama
RECRUITING
Birmingham
Arkansas
Arkansas Children's Hospital
RECRUITING
Little Rock
Arizona
Phoenix Childrens Hospital
RECRUITING
Phoenix
California
Kaiser Permanente Downey Medical Center
RECRUITING
Downey
Loma Linda University Medical Center
RECRUITING
Loma Linda
Children's Hospital Los Angeles
RECRUITING
Los Angeles
Mattel Children's Hospital UCLA
RECRUITING
Los Angeles
Valley Children's Hospital
RECRUITING
Madera
Kaiser Permanente-Oakland
RECRUITING
Oakland
Children's Hospital of Orange County
RECRUITING
Orange
Lucile Packard Children's Hospital Stanford University
RECRUITING
Palo Alto
University of California Davis Comprehensive Cancer Center
RECRUITING
Sacramento
Naval Medical Center -San Diego
RECRUITING
San Diego
Rady Children's Hospital - San Diego
RECRUITING
San Diego
UCSF Medical Center-Mission Bay
RECRUITING
San Francisco
Colorado
Children's Hospital Colorado
RECRUITING
Aurora
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
RECRUITING
Denver
Connecticut
Connecticut Children's Medical Center
RECRUITING
Hartford
Yale University
RECRUITING
New Haven
Washington, D.c.
Children's National Medical Center
RECRUITING
Washington D.c.
Delaware
Alfred I duPont Hospital for Children
RECRUITING
Wilmington
Florida
Golisano Children's Hospital of Southwest Florida
RECRUITING
Fort Myers
University of Florida Health Science Center - Gainesville
RECRUITING
Gainesville
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
RECRUITING
Hollywood
Nemours Children's Clinic-Jacksonville
RECRUITING
Jacksonville
Nicklaus Children's Hospital
RECRUITING
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
RECRUITING
Miami
AdventHealth Orlando
RECRUITING
Orlando
Nemours Children's Hospital
RECRUITING
Orlando
Johns Hopkins All Children's Hospital
RECRUITING
St. Petersburg
Saint Mary's Medical Center
RECRUITING
West Palm Beach
Georgia
Children's Healthcare of Atlanta - Arthur M Blank Hospital
RECRUITING
Atlanta
Memorial Health University Medical Center
RECRUITING
Savannah
Hawaii
Kapiolani Medical Center for Women and Children
RECRUITING
Honolulu
Iowa
Blank Children's Hospital
RECRUITING
Des Moines
University of Iowa/Holden Comprehensive Cancer Center
RECRUITING
Iowa City
Idaho
Saint Luke's Cancer Institute - Boise
RECRUITING
Boise
Illinois
Lurie Children's Hospital-Chicago
RECRUITING
Chicago
University of Chicago Comprehensive Cancer Center
RECRUITING
Chicago
University of Illinois
RECRUITING
Chicago
Advocate Children's Hospital-Oak Lawn
RECRUITING
Oak Lawn
Advocate Children's Hospital-Park Ridge
RECRUITING
Park Ridge
Saint Jude Midwest Affiliate
RECRUITING
Peoria
Southern Illinois University School of Medicine
RECRUITING
Springfield
Indiana
Riley Hospital for Children
RECRUITING
Indianapolis
Kentucky
University of Kentucky/Markey Cancer Center
RECRUITING
Lexington
Louisiana
Children's Hospital New Orleans
RECRUITING
New Orleans
Ochsner Medical Center Jefferson
RECRUITING
New Orleans
Massachusetts
Dana-Farber Cancer Institute
RECRUITING
Boston
Massachusetts General Hospital Cancer Center
RECRUITING
Boston
Tufts Children's Hospital
ACTIVE_NOT_RECRUITING
Boston
Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center
RECRUITING
Baltimore
Sinai Hospital of Baltimore
RECRUITING
Baltimore
Walter Reed National Military Medical Center
RECRUITING
Bethesda
Maine
Eastern Maine Medical Center
RECRUITING
Bangor
Maine Children's Cancer Program
RECRUITING
Scarborough
Michigan
C S Mott Children's Hospital
RECRUITING
Ann Arbor
Children's Hospital of Michigan
RECRUITING
Detroit
Henry Ford Health Saint John Hospital
ACTIVE_NOT_RECRUITING
Detroit
Wayne State University/Karmanos Cancer Institute
ACTIVE_NOT_RECRUITING
Detroit
Michigan State University
SUSPENDED
East Lansing
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
RECRUITING
Grand Rapids
Bronson Methodist Hospital
RECRUITING
Kalamazoo
Corewell Health Children's
RECRUITING
Royal Oak
Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis
RECRUITING
Minneapolis
University of Minnesota/Masonic Cancer Center
RECRUITING
Minneapolis
Mayo Clinic in Rochester
RECRUITING
Rochester
Missouri
University of Missouri Children's Hospital
RECRUITING
Columbia
Children's Mercy Hospitals and Clinics
RECRUITING
Kansas City
Mercy Hospital Saint Louis
RECRUITING
St Louis
Washington University School of Medicine
RECRUITING
St Louis
Mississippi
University of Mississippi Medical Center
RECRUITING
Jackson
North Carolina
Mission Hospital
RECRUITING
Asheville
UNC Lineberger Comprehensive Cancer Center
RECRUITING
Chapel Hill
Carolinas Medical Center/Levine Cancer Institute
RECRUITING
Charlotte
Duke University Medical Center
RECRUITING
Durham
East Carolina University
RECRUITING
Greenville
Wake Forest University Health Sciences
RECRUITING
Winston-salem
North Dakota
Sanford Broadway Medical Center
RECRUITING
Fargo
Nebraska
Children's Hospital and Medical Center of Omaha
RECRUITING
Omaha
University of Nebraska Medical Center
RECRUITING
Omaha
New Hampshire
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
RECRUITING
Lebanon
New Jersey
Hackensack University Medical Center
RECRUITING
Hackensack
Morristown Medical Center
RECRUITING
Morristown
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
RECRUITING
New Brunswick
Saint Peter's University Hospital
RECRUITING
New Brunswick
Newark Beth Israel Medical Center
RECRUITING
Newark
Saint Joseph's Regional Medical Center
RECRUITING
Paterson
New Mexico
University of New Mexico Cancer Center
RECRUITING
Albuquerque
Nevada
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
RECRUITING
Las Vegas
Summerlin Hospital Medical Center
RECRUITING
Las Vegas
Sunrise Hospital and Medical Center
RECRUITING
Las Vegas
University Medical Center of Southern Nevada
RECRUITING
Las Vegas
New York
Albany Medical Center
RECRUITING
Albany
Maimonides Medical Center
RECRUITING
Brooklyn
Roswell Park Cancer Institute
RECRUITING
Buffalo
NYU Langone Hospital - Long Island
RECRUITING
Mineola
The Steven and Alexandra Cohen Children's Medical Center of New York
RECRUITING
New Hyde Park
Laura and Isaac Perlmutter Cancer Center at NYU Langone
RECRUITING
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
RECRUITING
New York
University of Rochester
RECRUITING
Rochester
Stony Brook University Medical Center
RECRUITING
Stony Brook
State University of New York Upstate Medical University
RECRUITING
Syracuse
Montefiore Medical Center - Moses Campus
RECRUITING
The Bronx
New York Medical College
RECRUITING
Valhalla
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Cleveland Clinic Foundation
RECRUITING
Cleveland
Rainbow Babies and Childrens Hospital
RECRUITING
Cleveland
Nationwide Children's Hospital
RECRUITING
Columbus
Dayton Children's Hospital
RECRUITING
Dayton
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
RECRUITING
Toledo
Oklahoma
University of Oklahoma Health Sciences Center
RECRUITING
Oklahoma City
Oregon
Legacy Emanuel Children's Hospital
RECRUITING
Portland
Pennsylvania
Lehigh Valley Hospital-Cedar Crest
RECRUITING
Allentown
Geisinger Medical Center
RECRUITING
Danville
Penn State Children's Hospital
RECRUITING
Hershey
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
Children's Hospital of Pittsburgh of UPMC
RECRUITING
Pittsburgh
Rhode Island
Rhode Island Hospital
RECRUITING
Providence
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Prisma Health Richland Hospital
RECRUITING
Columbia
BI-LO Charities Children's Cancer Center
RECRUITING
Greenville
South Dakota
Sanford USD Medical Center - Sioux Falls
RECRUITING
Sioux Falls
Tennessee
East Tennessee Childrens Hospital
RECRUITING
Knoxville
Saint Jude Children's Research Hospital
RECRUITING
Memphis
The Children's Hospital at TriStar Centennial
RECRUITING
Nashville
Vanderbilt University/Ingram Cancer Center
RECRUITING
Nashville
Texas
Dell Children's Medical Center of Central Texas
RECRUITING
Austin
Driscoll Children's Hospital
RECRUITING
Corpus Christi
Medical City Dallas Hospital
ACTIVE_NOT_RECRUITING
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
RECRUITING
Dallas
El Paso Children's Hospital
RECRUITING
El Paso
Cook Children's Medical Center
RECRUITING
Fort Worth
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
RECRUITING
Houston
Covenant Children's Hospital
RECRUITING
Lubbock
UMC Cancer Center / UMC Health System
RECRUITING
Lubbock
Children's Hospital of San Antonio
RECRUITING
San Antonio
Methodist Children's Hospital of South Texas
RECRUITING
San Antonio
University of Texas Health Science Center at San Antonio
RECRUITING
San Antonio
Utah
Primary Children's Hospital
RECRUITING
Salt Lake City
Virginia
VCU Massey Comprehensive Cancer Center
RECRUITING
Richmond
Vermont
University of Vermont and State Agricultural College
RECRUITING
Burlington
Washington
Seattle Children's Hospital
RECRUITING
Seattle
Providence Sacred Heart Medical Center and Children's Hospital
RECRUITING
Spokane
Madigan Army Medical Center
RECRUITING
Tacoma
Mary Bridge Children's Hospital and Health Center
RECRUITING
Tacoma
Wisconsin
Saint Vincent Hospital Cancer Center Green Bay
RECRUITING
Green Bay
University of Wisconsin Carbone Cancer Center - University Hospital
RECRUITING
Madison
Marshfield Medical Center-Marshfield
SUSPENDED
Marshfield
Children's Hospital of Wisconsin
RECRUITING
Milwaukee
West Virginia
West Virginia University Healthcare
SUSPENDED
Morgantown
Other Locations
Canada
IWK Health Centre
SUSPENDED
Halifax
McMaster Children's Hospital at Hamilton Health Sciences
SUSPENDED
Hamilton
Kingston Health Sciences Centre
SUSPENDED
Kingston
Children's Hospital
SUSPENDED
London
Children's Hospital of Eastern Ontario
SUSPENDED
Ottawa
Janeway Child Health Centre
SUSPENDED
St. John's
Hospital for Sick Children
SUSPENDED
Toronto
British Columbia Children's Hospital
SUSPENDED
Vancouver
CancerCare Manitoba
SUSPENDED
Winnipeg
Puerto Rico
HIMA San Pablo Oncologic Hospital
ACTIVE_NOT_RECRUITING
Caguas
Time Frame
Start Date: 2018-05-14
Estimated Completion Date: 2030-09-30
Participants
Target number of participants: 750
Treatments
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.
Sponsors
Leads: Children's Oncology Group
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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