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

NCT03126916

This study is recruiting at 143 US sites in 45 states, according to its ClinicalTrials.gov record last updated .

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • Ganglioneuroblastoma
  • Ganglioneuroblastoma, Nodular
  • Neuroblastoma

Eligibility basics and study details

Study type
Interventional
Phase
Phase 3
Ages
365 days to 30 years
Sex
All
Healthy volunteers
Not accepted
Sponsor
Children's Oncology Group
Last updated on ClinicalTrials.gov
August 25, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

Alabama · 1

  • Children's Hospital of Alabama · Birmingham, AL

Arizona · 1

  • Phoenix Childrens Hospital · Phoenix, AZ

Arkansas · 1

  • Arkansas Children's Hospital · Little Rock, AR

California · 12

  • Kaiser Permanente Downey Medical Center · Downey, CA
  • Loma Linda University Medical Center · Loma Linda, CA
  • Children's Hospital Los Angeles · Los Angeles, CA
  • Mattel Children's Hospital UCLA · Los Angeles, CA
  • Valley Children's Hospital · Madera, CA
  • Kaiser Permanente-Oakland · Oakland, CA
  • Children's Hospital of Orange County · Orange, CA
  • Lucile Packard Children's Hospital Stanford University · Palo Alto, CA
  • University of California Davis Comprehensive Cancer Center · Sacramento, CA
  • Naval Medical Center -San Diego · San Diego, CA
  • Rady Children's Hospital - San Diego · San Diego, CA
  • UCSF Medical Center-Mission Bay · San Francisco, CA

Colorado · 2

  • Children's Hospital Colorado · Aurora, CO
  • Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center · Denver, CO

Connecticut · 2

  • Connecticut Children's Medical Center · Hartford, CT
  • Yale University · New Haven, CT

Delaware · 1

  • Alfred I duPont Hospital for Children · Wilmington, DE

District of Columbia · 1

  • Children's National Medical Center · Washington D.C., DC

Florida · 10

  • Golisano Children's Hospital of Southwest Florida · Fort Myers, FL
  • UF Health Cancer Institute - Gainesville · Gainesville, FL
  • Memorial Regional Hospital/Joe DiMaggio Children's Hospital · Hollywood, FL
  • Nemours Children's Clinic-Jacksonville · Jacksonville, FL
  • Nicklaus Children's Hospital · Miami, FL
  • University of Miami Miller School of Medicine-Sylvester Cancer Center · Miami, FL
  • AdventHealth Orlando · Orlando, FL
  • Nemours Children's Hospital · Orlando, FL
  • Johns Hopkins All Children's Hospital · St. Petersburg, FL
  • Saint Mary's Medical Center · West Palm Beach, FL

Georgia · 2

  • Children's Healthcare of Atlanta - Arthur M Blank Hospital · Atlanta, GA
  • Memorial Health University Medical Center · Savannah, GA

Idaho · 1

  • Saint Luke's Cancer Institute - Boise · Boise, ID

Illinois · 7

  • Lurie Children's Hospital-Chicago · Chicago, IL
  • University of Chicago Comprehensive Cancer Center · Chicago, IL
  • University of Illinois · Chicago, IL
  • Advocate Children's Hospital-Oak Lawn · Oak Lawn, IL
  • Advocate Children's Hospital-Park Ridge · Park Ridge, IL
  • OSF Children's Hospital of Illinois · Peoria, IL
  • Southern Illinois University School of Medicine · Springfield, IL

Indiana · 1

  • Riley Hospital for Children · Indianapolis, IN

Iowa · 2

  • Blank Children's Hospital · Des Moines, IA
  • University of Iowa/Holden Comprehensive Cancer Center · Iowa City, IA

Kentucky · 1

  • University of Kentucky/Markey Cancer Center · Lexington, KY

Louisiana · 2

  • Children's Hospital New Orleans · New Orleans, LA
  • Ochsner Medical Center Jefferson · New Orleans, LA

Maine · 2

  • Eastern Maine Medical Center · Bangor, ME
  • Maine Children's Cancer Program · Scarborough, ME

Maryland · 3

  • Johns Hopkins University/Sidney Kimmel Cancer Center · Baltimore, MD
  • Sinai Hospital of Baltimore · Baltimore, MD
  • University of Maryland/Greenebaum Cancer Center · Baltimore, MD

Massachusetts · 2

  • Dana-Farber Cancer Institute · Boston, MA
  • Massachusetts General Hospital Cancer Center · Boston, MA

Michigan · 5

  • C S Mott Children's Hospital · Ann Arbor, MI
  • Children's Hospital of Michigan · Detroit, MI
  • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital · Grand Rapids, MI
  • Bronson Methodist Hospital · Kalamazoo, MI
  • Corewell Health Children's · Royal Oak, MI

Minnesota · 3

  • Children's Hospitals and Clinics of Minnesota - Minneapolis · Minneapolis, MN
  • University of Minnesota/Masonic Cancer Center · Minneapolis, MN
  • Mayo Clinic in Rochester · Rochester, MN

Mississippi · 1

  • University of Mississippi Medical Center · Jackson, MS

Missouri · 4

  • University of Missouri Children's Hospital · Columbia, MO
  • Children's Mercy Hospitals and Clinics · Kansas City, MO
  • Mercy Hospital Saint Louis · St Louis, MO
  • Washington University School of Medicine · St Louis, MO

Nebraska · 2

  • Children's Hospital and Medical Center of Omaha · Omaha, NE
  • University of Nebraska Medical Center · Omaha, NE

Nevada · 4

  • Alliance for Childhood Diseases/Cure 4 the Kids Foundation · Las Vegas, NV
  • Summerlin Hospital Medical Center · Las Vegas, NV
  • Sunrise Hospital and Medical Center · Las Vegas, NV
  • University Medical Center of Southern Nevada · Las Vegas, NV

New Hampshire · 1

  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center · Lebanon, NH

New Jersey · 6

  • Hackensack University Medical Center · Hackensack, NJ
  • Morristown Medical Center · Morristown, NJ
  • Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital · New Brunswick, NJ
  • Saint Peter's University Hospital · New Brunswick, NJ
  • Newark Beth Israel Medical Center · Newark, NJ
  • Saint Joseph's Regional Medical Center · Paterson, NJ

New Mexico · 1

  • University of New Mexico Cancer Center · Albuquerque, NM

New York · 11

  • Albany Medical Center · Albany, NY
  • Maimonides Medical Center · Brooklyn, NY
  • Roswell Park Cancer Institute · Buffalo, NY
  • NYU Langone Hospital - Long Island · Mineola, NY
  • The Steven and Alexandra Cohen Children's Medical Center of New York · New Hyde Park, NY
  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center · New York, NY
  • University of Rochester · Rochester, NY
  • Stony Brook University Medical Center · Stony Brook, NY
  • State University of New York Upstate Medical University · Syracuse, NY
  • Montefiore Medical Center - Moses Campus · The Bronx, NY
  • New York Medical College · Valhalla, NY

North Carolina · 6

  • Mission Hospital · Asheville, NC
  • UNC Lineberger Comprehensive Cancer Center · Chapel Hill, NC
  • Carolinas Medical Center/Levine Cancer Institute · Charlotte, NC
  • Duke University Medical Center · Durham, NC
  • East Carolina University · Greenville, NC
  • Wake Forest University Health Sciences · Winston-Salem, NC

North Dakota · 1

  • Sanford Broadway Medical Center · Fargo, ND

Ohio · 6

  • Cincinnati Children's Hospital Medical Center · Cincinnati, OH
  • Cleveland Clinic Foundation · Cleveland, OH
  • Rainbow Babies and Childrens Hospital · Cleveland, OH
  • Nationwide Children's Hospital · Columbus, OH
  • Dayton Children's Hospital · Dayton, OH
  • ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital · Toledo, OH

Oklahoma · 1

  • University of Oklahoma Health Sciences Center · Oklahoma City, OK

Oregon · 1

  • Legacy Emanuel Children's Hospital · Portland, OR

Pennsylvania · 5

  • Lehigh Valley Hospital-Cedar Crest · Allentown, PA
  • Geisinger Medical Center · Danville, PA
  • Penn State Children's Hospital · Hershey, PA
  • Children's Hospital of Philadelphia · Philadelphia, PA
  • Children's Hospital of Pittsburgh of UPMC · Pittsburgh, PA

Rhode Island · 1

  • Rhode Island Hospital · Providence, RI

South Carolina · 3

  • Medical University of South Carolina · Charleston, SC
  • Prisma Health Richland Hospital · Columbia, SC
  • BI-LO Charities Children's Cancer Center · Greenville, SC

South Dakota · 1

  • Sanford USD Medical Center - Sioux Falls · Sioux Falls, SD

Tennessee · 4

  • East Tennessee Childrens Hospital · Knoxville, TN
  • Saint Jude Children's Research Hospital · Memphis, TN
  • The Children's Hospital at TriStar Centennial · Nashville, TN
  • Vanderbilt University/Ingram Cancer Center · Nashville, TN

Texas · 11

  • Dell Children's Medical Center of Central Texas · Austin, TX
  • Driscoll Children's Hospital · Corpus Christi, TX
  • UT Southwestern/Simmons Cancer Center-Dallas · Dallas, TX
  • El Paso Children's Hospital · El Paso, TX
  • Cook Children's Medical Center · Fort Worth, TX
  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center · Houston, TX
  • Covenant Children's Hospital · Lubbock, TX
  • UMC Cancer Center / UMC Health System · Lubbock, TX
  • Children's Hospital of San Antonio · San Antonio, TX
  • Methodist Children's Hospital of South Texas · San Antonio, TX
  • University of Texas Health Science Center at San Antonio · San Antonio, TX

Utah · 1

  • Primary Children's Hospital · Salt Lake City, UT

Vermont · 1

  • University of Vermont and State Agricultural College · Burlington, VT

Washington · 4

  • Seattle Children's Hospital · Seattle, WA
  • Providence Sacred Heart Medical Center and Children's Hospital · Spokane, WA
  • Madigan Army Medical Center · Tacoma, WA
  • Mary Bridge Children's Hospital and Health Center · Tacoma, WA

West Virginia · 1

  • West Virginia University Healthcare · Morgantown, WV

Wisconsin · 4

  • Saint Vincent Hospital Cancer Center Green Bay · Green Bay, WI
  • University of Wisconsin Carbone Cancer Center - University Hospital · Madison, WI
  • Marshfield Medical Center-Marshfield · Marshfield, WI
  • Children's Hospital of Wisconsin · Milwaukee, WI

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.