Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)
Sponsor: Children's Oncology Group • ClinicalTrials.gov ID: NCT03126916
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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.
Interventions
-
Autologous Hematopoietic Stem Cell Transplantation
(Procedure)
Undergo autologous HSCT
-
Biospecimen Collection
(Procedure)
Undergo blood sample collection
-
Bone Marrow Aspiration and Biopsy
(Procedure)
Undergo bone marrow aspiration and biopsy
-
Busulfan
(Drug)
Given IV
-
Carboplatin
(Drug)
Given IV
-
Cisplatin
(Drug)
Given IV
-
Computed Tomography
(Procedure)
Undergo CT scan
-
Cyclophosphamide
(Drug)
Given IV
-
Dexrazoxane Hydrochloride
(Drug)
Given IV
-
Dinutuximab
(Biological)
Given IV
-
Doxorubicin Hydrochloride
(Drug)
Given IV
-
Echocardiography Test
(Procedure)
Undergo echocardiography
-
Etoposide Phosphate
(Drug)
Given IV
-
External Beam Radiation Therapy
(Radiation)
Undergo EBRT
-
Iobenguane I-123
(Radiation)
Given 123 I-MIBG
-
Iobenguane I-131
(Radiation)
Given IV
-
Isotretinoin
(Drug)
Given PO
-
Lorlatinib
(Drug)
Given PO
-
Magnetic Resonance Imaging
(Procedure)
Undergo MRI
-
Melphalan Hydrochloride
(Drug)
Given IV
-
Multigated Acquisition Scan
(Procedure)
Undergo MUGA scan
-
Positron Emission Tomography
(Procedure)
Undergo PET scan
-
Sargramostim
(Biological)
Given SC
-
Therapeutic Conventional Surgery
(Procedure)
Undergo standard of care surgery
-
Thiotepa
(Drug)
Given IV
-
Topotecan Hydrochloride
(Drug)
Given IV
-
Vincristine Sulfate
(Drug)
Given IV
Eligibility criteria
Conditions
Locations
- 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 D.C., District of Columbia, United States
- Golisano Children's Hospital of Southwest Florida — Fort Myers, Florida, United States
- UF Health Cancer Institute - 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 — St. Petersburg, Florida, United States
- Saint Mary's Medical Center — West Palm Beach, Florida, United States
- Children's Healthcare of Atlanta - Arthur M Blank Hospital — Atlanta, Georgia, 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
- OSF Children's Hospital of Illinois — 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
- University of Maryland/Greenebaum Cancer Center — Baltimore, Maryland, 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
- Henry Ford Health Saint John Hospital — Detroit, Michigan, United States
- Michigan State University — 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 — St Louis, Missouri, United States
- Mercy Hospital Saint Louis — St 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
- 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
- Montefiore Medical Center - Moses Campus — The Bronx, 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
- VCU Massey Comprehensive 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 — St. 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
- Centre Hospitalier Universitaire Sainte-Justine — Montreal, Quebec, Canada
- CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) — Québec, Canada
- HIMA San Pablo Oncologic Hospital — Caguas, Puerto Rico
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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