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This phase III trial tests how well the addition of dinutuximab to Induction chemotherapy along with standard of care surgical resection of the primary tumor, radiation, stem cell transplantation, and immunotherapy works for treating children with newly diagnosed high-risk neuroblastoma. Dinutuximab is a monoclonal antibody that binds to a molecule called GD2, which is found on the surface of neuroblastoma cells, but is not present on many healthy or normal cells in the body. When dinutuximab binds to the neuroblastoma cells, it helps signal the immune system to kill the tumor cells. This helps the cells of the immune system kill the cancer cells, this is a type of immunotherapy. When chemotherapy and immunotherapy are given together, during the same treatment cycle, it is called chemoimmunotherapy. This clinical trial randomly assigns patients to receive either standard chemotherapy and surgery or chemoimmunotherapy (chemotherapy plus dinutuximab) and surgery during Induction therapy. Chemotherapy drugs administered during Induction include, cyclophosphamide, topotecan, cisplatin, etoposide, vincristine, and doxorubicin. These drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing or by stopping them from spreading. Upon completion of 5 cycles of Induction therapy, a disease evaluation is completed to determine how well the treatment worked. If the tumor responds to therapy, patients receive a tandem transplantation with stem cell rescue. If the tumor has little improvement or worsens, patients receive chemoimmunotherapy on Extended Induction. During Extended Induction, dinutuximab is given with irinotecan, temozolomide. Patients with a good response to therapy move on to Consolidation therapy, when very high doses of chemotherapy are given at two separate points to kill any remaining cancer cells. Following, transplant, radiation therapy is given to the site where the cancer originated (primary site) and to any other areas that are still active at the end of Induction. The final stage of therapy is Post-Consolidation. During Post-Consolidation, dinutuximab is given with isotretinoin, with the goal of maintaining the response achieved with the previous therapy. Adding dinutuximab to Induction chemotherapy along with standard of care surgical resection of the primary tumor, radiation, stem cell transplantation, and immunotherapy may be better at treating children with newly diagnosed high-risk neuroblastoma.
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 | N/A - 30 Years |
Gender | All |
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. |
NCT06172296 |
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 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
National Cancer Institute (NCI) |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Sara M Federico |
Principal Investigator Affiliation | Children's Oncology Group |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
NIH |
Overall Status | Recruiting |
Countries | Australia, Canada, New Zealand, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Ganglioneuroblastoma, Nodular, Neuroblastoma |
PRIMARY OBJECTIVE:
Active Comparator: Arm A (SOC treatment)
See detailed description
Experimental: Arm B (Dinutuximab in induction)
See detailed description
Procedure: - Biospecimen Collection
Undergo blood and urine sample collection
Procedure: - Bone Marrow Aspiration
Undergo bone marrow aspiration
Procedure: - Bone Marrow Biopsy
Undergo bone marrow biopsy
Drug: - Carboplatin
Given IV
Drug: - Cisplatin
Given IV
Procedure: - Computed Tomography
Undergo CT scan
Drug: - Cyclophosphamide
Given IV
Biological: - Dinutuximab
Given IV
Drug: - Doxorubicin
Given IV
Procedure: - Echocardiography Test
Undergo ECHO
Drug: - Etoposide
Given IV
Procedure: - FDG-Positron Emission Tomography and Computed Tomography Scan
Undergo FDG PET
Procedure: - Hematopoietic Cell Transplantation
Undergo stem cell infusion
Drug: - Irinotecan
Given IV
Drug: - Isotretinoin
Given PO
Procedure: - Leukapheresis
Undergo apheresis
Procedure: - Magnetic Resonance Imaging
Undergo MRI
Drug: - Melphalan
Given IV
Procedure: - Multigated Acquisition Scan
Undergo MUGA
Radiation: - Radiation Therapy
Undergo radiation therapy
Procedure: - Radionuclide Imaging
Undergo I-MIBG scan
Other: - Survey Administration
Ancillary studies
Drug: - Temozolomide
Given PO or via NG or G tube
Drug: - Thiotepa
Given IV
Drug: - Topotecan
Given IV
Procedure: - Tumor Resection
Undergo tumor resection surgery
Drug: - Vincristine
Given IV
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, Alabama, 35233
Status
Recruiting
Address
USA Health Strada Patient Care Center
Mobile, Alabama, 36604
Status
Recruiting
Address
Phoenix Childrens Hospital
Phoenix, Arizona, 85016
Status
Recruiting
Address
Banner University Medical Center - Tucson
Tucson, Arizona, 85719
Status
Recruiting
Address
Arkansas Children's Hospital
Little Rock, Arkansas, 72202-3591
Status
Recruiting
Address
Kaiser Permanente Downey Medical Center
Downey, California, 90242
Status
Recruiting
Address
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Status
Recruiting
Address
Loma Linda University Medical Center
Loma Linda, California, 92354
Status
Recruiting
Address
Miller Children's and Women's Hospital Long Beach
Long Beach, California, 90806
Status
Recruiting
Address
Children's Hospital Los Angeles
Los Angeles, California, 90027
Status
Recruiting
Address
Cedars Sinai Medical Center
Los Angeles, California, 90048
Status
Recruiting
Address
Mattel Children's Hospital UCLA
Los Angeles, California, 90095
Status
Recruiting
Address
Valley Children's Hospital
Madera, California, 93636
Status
Recruiting
Address
UCSF Benioff Children's Hospital Oakland
Oakland, California, 94609
Status
Recruiting
Address
Kaiser Permanente-Oakland
Oakland, California, 94611
Status
Recruiting
Address
Children's Hospital of Orange County
Orange, California, 92868
Status
Recruiting
Address
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, 94304
Status
Recruiting
Address
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
Status
Recruiting
Address
UCSF Medical Center-Mission Bay
San Francisco, California, 94158
Status
Recruiting
Address
Children's Hospital Colorado
Aurora, Colorado, 80045
Status
Recruiting
Address
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Status
Recruiting
Address
Yale University
New Haven, Connecticut, 06520
Status
Recruiting
Address
Alfred I duPont Hospital for Children
Wilmington, Delaware, 19803
Status
Recruiting
Address
Children's National Medical Center
Washington, District of Columbia, 20010
Status
Recruiting
Address
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, 33908
Status
Suspended
Address
University of Florida Health Science Center - Gainesville
Gainesville, Florida, 32610
Status
Recruiting
Address
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021
Status
Recruiting
Address
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, 32207
Status
Recruiting
Address
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
Status
Recruiting
Address
Nicklaus Children's Hospital
Miami, Florida, 33155
Status
Recruiting
Address
AdventHealth Orlando
Orlando, Florida, 32803
Status
Recruiting
Address
Arnold Palmer Hospital for Children
Orlando, Florida, 32806
Status
Recruiting
Address
Nemours Children's Hospital
Orlando, Florida, 32827
Status
Recruiting
Address
Johns Hopkins All Children's Hospital
Saint Petersburg, Florida, 33701
Status
Recruiting
Address
Saint Mary's Medical Center
West Palm Beach, Florida, 33407
Status
Recruiting
Address
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, 30329
Status
Recruiting
Address
Lurie Children's Hospital-Chicago
Chicago, Illinois, 60611
Status
Recruiting
Address
University of Illinois
Chicago, Illinois, 60612
Status
Recruiting
Address
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Status
Recruiting
Address
Advocate Children's Hospital-Oak Lawn
Oak Lawn, Illinois, 60453
Status
Recruiting
Address
Advocate Children's Hospital-Park Ridge
Park Ridge, Illinois, 60068
Status
Recruiting
Address
Saint Jude Midwest Affiliate
Peoria, Illinois, 61637
Status
Recruiting
Address
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
Status
Recruiting
Address
Riley Hospital for Children
Indianapolis, Indiana, 46202
Status
Recruiting
Address
Blank Children's Hospital
Des Moines, Iowa, 50309
Status
Recruiting
Address
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
Status
Recruiting
Address
Wesley Medical Center
Wichita, Kansas, 67214
Status
Recruiting
Address
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
Status
Recruiting
Address
Children's Hospital New Orleans
New Orleans, Louisiana, 70118
Status
Recruiting
Address
Eastern Maine Medical Center
Bangor, Maine, 04401
Status
Recruiting
Address
Maine Children's Cancer Program
Scarborough, Maine, 04074
Status
Recruiting
Address
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Status
Recruiting
Address
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
Status
Recruiting
Address
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Status
Recruiting
Address
C S Mott Children's Hospital
Ann Arbor, Michigan, 48109
Status
Recruiting
Address
Children's Hospital of Michigan
Detroit, Michigan, 48201
Status
Recruiting
Address
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503
Status
Suspended
Address
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
Status
Recruiting
Address
Corewell Health Children's
Royal Oak, Michigan, 48073
Status
Recruiting
Address
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, 55404
Status
Recruiting
Address
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455
Status
Recruiting
Address
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Status
Recruiting
Address
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Status
Recruiting
Address
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
Status
Recruiting
Address
Washington University School of Medicine
Saint Louis, Missouri, 63110
Status
Recruiting
Address
Mercy Hospital Saint Louis
Saint Louis, Missouri, 63141
Status
Recruiting
Address
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, 68114
Status
Recruiting
Address
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Status
Recruiting
Address
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
Status
Recruiting
Address
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Status
Recruiting
Address
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903
Status
Recruiting
Address
Saint Joseph's Regional Medical Center
Paterson, New Jersey, 07503
Status
Recruiting
Address
Albany Medical Center
Albany, New York, 12208
Status
Recruiting
Address
Montefiore Medical Center - Moses Campus
Bronx, New York, 10467
Status
Recruiting
Address
Roswell Park Cancer Institute
Buffalo, New York, 14263
Status
Recruiting
Address
NYU Langone Hospital - Long Island
Mineola, New York, 11501
Status
Recruiting
Address
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, 11040
Status
Recruiting
Address
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
Status
Recruiting
Address
New York Medical College
Valhalla, New York, 10595
Status
Recruiting
Address
Mission Hospital
Asheville, North Carolina, 28801
Status
Recruiting
Address
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Status
Recruiting
Address
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203
Status
Recruiting
Address
Duke University Medical Center
Durham, North Carolina, 27710
Status
Recruiting
Address
East Carolina University
Greenville, North Carolina, 27834
Status
Recruiting
Address
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Status
Recruiting
Address
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
Status
Recruiting
Address
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308
Status
Recruiting
Address
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Status
Recruiting
Address
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, 44106
Status
Recruiting
Address
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Status
Recruiting
Address
Nationwide Children's Hospital
Columbus, Ohio, 43205
Status
Recruiting
Address
Dayton Children's Hospital
Dayton, Ohio, 45404
Status
Recruiting
Address
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo, Ohio, 43606
Status
Recruiting
Address
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Status
Recruiting
Address
Legacy Emanuel Children's Hospital
Portland, Oregon, 97227
Status
Recruiting
Address
Geisinger Medical Center
Danville, Pennsylvania, 17822
Status
Recruiting
Address
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Status
Recruiting
Address
Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134
Status
Recruiting
Address
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
Status
Recruiting
Address
Rhode Island Hospital
Providence, Rhode Island, 02903
Status
Recruiting
Address
Medical University of South Carolina
Charleston, South Carolina, 29425
Status
Recruiting
Address
Prisma Health Richland Hospital
Columbia, South Carolina, 29203
Status
Recruiting
Address
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, 29605
Status
Recruiting
Address
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
Status
Recruiting
Address
East Tennessee Childrens Hospital
Knoxville, Tennessee, 37916
Status
Recruiting
Address
Saint Jude Children's Research Hospital
Memphis, Tennessee, 38105
Status
Recruiting
Address
The Children's Hospital at TriStar Centennial
Nashville, Tennessee, 37203
Status
Suspended
Address
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
Status
Recruiting
Address
Dell Children's Medical Center of Central Texas
Austin, Texas, 78723
Status
Recruiting
Address
Driscoll Children's Hospital
Corpus Christi, Texas, 78411
Status
Recruiting
Address
Medical City Dallas Hospital
Dallas, Texas, 75230
Status
Recruiting
Address
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
Status
Recruiting
Address
El Paso Children's Hospital
El Paso, Texas, 79905
Status
Recruiting
Address
Cook Children's Medical Center
Fort Worth, Texas, 76104
Status
Recruiting
Address
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77030
Status
Recruiting
Address
M D Anderson Cancer Center
Houston, Texas, 77030
Status
Recruiting
Address
Covenant Children's Hospital
Lubbock, Texas, 79410
Status
Recruiting
Address
UMC Cancer Center / UMC Health System
Lubbock, Texas, 79415
Status
Recruiting
Address
Children's Hospital of San Antonio
San Antonio, Texas, 78207
Status
Recruiting
Address
Methodist Children's Hospital of South Texas
San Antonio, Texas, 78229
Status
Recruiting
Address
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Status
Recruiting
Address
Primary Children's Hospital
Salt Lake City, Utah, 84113
Status
Recruiting
Address
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
Status
Recruiting
Address
Seattle Children's Hospital
Seattle, Washington, 98105
Status
Recruiting
Address
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, 99204
Status
Recruiting
Address
Mary Bridge Children's Hospital and Health Center
Tacoma, Washington, 98405
Status
Recruiting
Address
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792
Status
Suspended
Address
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
Status
Recruiting
Address
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
Status
Recruiting
Address
Sydney Children's Hospital
Randwick, New South Wales, 2031
Status
Recruiting
Address
The Children's Hospital at Westmead
Westmead, New South Wales, 2145
Status
Recruiting
Address
Queensland Children's Hospital
South Brisbane, Queensland, 4101
Status
Recruiting
Address
Perth Children's Hospital
Perth, Western Australia, 6009
Status
Recruiting
Address
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
Status
Recruiting
Address
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Status
Recruiting
Address
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4
Status
Recruiting
Address
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
Status
Recruiting
Address
IWK Health Centre
Halifax, Nova Scotia, B3K 6R8
Status
Recruiting
Address
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, L8N 3Z5
Status
Recruiting
Address
Children's Hospital
London, Ontario, N6A 5W9
Status
Recruiting
Address
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Status
Recruiting
Address
The Montreal Children's Hospital of the MUHC
Montreal, Quebec, H3H 1P3
Status
Recruiting
Address
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, H3T 1C5
Status
Recruiting
Address
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Sherbrooke, Quebec, J1H 5N4
Status
Recruiting
Address
Jim Pattison Children's Hospital
Saskatoon, Saskatchewan, S7N 0W8
Status
Recruiting
Address
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
Quebec, , G1V 4G2
Status
Recruiting
Address
Starship Children's Hospital
Grafton, Auckland, 1145