Dinutuximab
- Generic Name
- Dinutuximab
- Brand Names
- Unituxin, Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron)
- Drug Type
- Biotech
- Chemical Formula
- -
- CAS Number
- 1363687-32-4
- Unique Ingredient Identifier
- 7SQY4ZUD30
- Background
Dinutuximab is an IgG1 monoclonal human/mouse chimeric antibody against GD2, a disialoganglioside expressed on tumors of neuroectodermal origin, including human neuroblastoma and melanoma, with highly restricted expression on normal tissues. It is composed of the variable heavy- and light-chain regions of the murine anti-GD2 mAb 14.18 and the constant region...
- Indication
Dinutuximab is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy. Despite a high clinical response seen ...
- Associated Conditions
- High Risk Neuroblastoma
- Associated Therapies
- -
NK Cells Infusions With Irinotecan, Temozolomide, and Dinutuximab
- Conditions
- Interventions
- First Posted Date
- 2019-12-26
- Last Posted Date
- 2024-02-16
- Lead Sponsor
- Nationwide Children's Hospital
- Target Recruit Count
- 31
- Registration Number
- NCT04211675
- Locations
- 🇺🇸
Nationwide Children's Hospital, Columbus, Ohio, United States
Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma
- Conditions
- Interventions
- First Posted Date
- 2019-01-07
- Last Posted Date
- 2024-12-04
- Lead Sponsor
- Children's Oncology Group
- Target Recruit Count
- 95
- Registration Number
- NCT03794349
- Locations
- 🇺🇸
Connecticut Children's Medical Center, Hartford, Connecticut, United States
🇺🇸Yale University, New Haven, Connecticut, United States
🇺🇸Children's National Medical Center, Washington, District of Columbia, United States
Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma
- Conditions
- Interventions
- Procedure: Autologous Hematopoietic Stem Cell TransplantationDrug: CarboplatinDrug: CisplatinDrug: CyclophosphamideDrug: DexrazoxaneBiological: DinutuximabDrug: DoxorubicinDrug: EtoposideRadiation: External Beam Radiation TherapyDrug: IsotretinoinDrug: MelphalanBiological: SargramostimDrug: ThiotepaDrug: TopotecanDrug: Vincristine
- First Posted Date
- 2018-12-26
- Last Posted Date
- 2024-10-17
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 42
- Registration Number
- NCT03786783
- Locations
- 🇺🇸
Saint Jude Children's Research Hospital, Memphis, Tennessee, United States
🇳🇿Starship Children's Hospital, Grafton, Auckland, New Zealand
🇦🇺The Children's Hospital at Westmead, Westmead, New South Wales, Australia
MIBG With Dinutuximab +/- Vorinostat
- Conditions
- Interventions
- First Posted Date
- 2017-11-06
- Last Posted Date
- 2024-11-18
- Target Recruit Count
- 45
- Registration Number
- NCT03332667
- Locations
- 🇺🇸
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus, Atlanta, Georgia, United States
🇺🇸Cook Children's Healthcare System, Fort Worth, Texas, United States
🇺🇸Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)
- Conditions
- Interventions
- Procedure: Autologous Hematopoietic Stem Cell TransplantationProcedure: Biospecimen CollectionProcedure: Bone Marrow Aspiration and BiopsyDrug: CarboplatinDrug: BusulfanDrug: CisplatinProcedure: Computed TomographyDrug: CyclophosphamideDrug: Dexrazoxane HydrochlorideBiological: DinutuximabDrug: Doxorubicin HydrochlorideProcedure: EchocardiographyDrug: Etoposide PhosphateRadiation: External Beam Radiation TherapyRadiation: Iobenguane I-123Drug: IsotretinoinRadiation: Iobenguane I-131Procedure: Multigated Acquisition ScanDrug: LorlatinibDrug: Melphalan HydrochlorideProcedure: Positron Emission TomographyProcedure: Magnetic Resonance ImagingBiological: SargramostimProcedure: Therapeutic Conventional SurgeryDrug: ThiotepaDrug: Topotecan HydrochlorideDrug: Vincristine Sulfate
- First Posted Date
- 2017-04-25
- Last Posted Date
- 2024-12-04
- Lead Sponsor
- Children's Oncology Group
- Target Recruit Count
- 724
- Registration Number
- NCT03126916
- Locations
- 🇺🇸
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
Phase II Study of Monoclonal Antibody ch14.18/CHO Continuous Infusion in Patients With Primary Refractory or Relapsed Neuroblastoma
- First Posted Date
- 2016-04-19
- Last Posted Date
- 2021-10-04
- Lead Sponsor
- University Medicine Greifswald
- Target Recruit Count
- 40
- Registration Number
- NCT02743429
- Locations
- 🇩🇪
University Medicine Greifswald, Greifswald, Germany
🇦🇹St. Anna Kinderkrebsforschung e.V. CHILDREN'S CANCER RESEARCH INSTITUTE, Wien, Austria
Post-Marketing Assessment of Immunogenicity and Safety of Unituxin® in High-Risk Neuroblastoma Patients
- First Posted Date
- 2016-02-26
- Last Posted Date
- 2019-08-05
- Lead Sponsor
- United Therapeutics
- Target Recruit Count
- 13
- Registration Number
- NCT02693171
- Locations
- 🇺🇸
University of Chicago, Chicago, Illinois, United States
🇺🇸Duke University Medical Center, Durham, North Carolina, United States
🇺🇸Dana Farber Cancer Institute, Boston, Massachusetts, United States
Immunotherapy of Relapsed Refractory Neuroblastoma With Expanded NK Cells
- Conditions
- Interventions
- First Posted Date
- 2015-10-12
- Last Posted Date
- 2024-11-05
- Target Recruit Count
- 13
- Registration Number
- NCT02573896
- Locations
- 🇺🇸
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus, Atlanta, Georgia, United States
🇺🇸Children's Hospital Los Angeles, Los Angeles, California, United States
🇺🇸C.S Mott Children's Hospital, Ann Arbor, Michigan, United States
Activity Study of Bevacizumab With Temozolomide ± Irinotecan for Neuroblastoma in Children
- Conditions
- Interventions
- First Posted Date
- 2014-12-04
- Last Posted Date
- 2024-05-14
- Lead Sponsor
- University of Birmingham
- Target Recruit Count
- 225
- Registration Number
- NCT02308527
- Locations
- 🇦🇹
St Anna Children's Hospital and CCRI/Studies and Statistics, Vienna, Austria
🇩🇰University Hospital Rigshospitalet, Copenhagen, Denmark
🇮🇹Ospedale Pediatrico Bambino Gseu, Rome, Italy
Lenalidomide and Dinutuximab With or Without Isotretinoin in Treating Younger Patients With Refractory or Recurrent Neuroblastoma
- Conditions
- Interventions
- First Posted Date
- 2012-10-22
- Last Posted Date
- 2024-11-26
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 27
- Registration Number
- NCT01711554
- Locations
- 🇺🇸
Children's Healthcare of Atlanta - Arthur M Blank Hospital, Atlanta, Georgia, United States
🇺🇸Children's Hospital Los Angeles, Los Angeles, California, United States
🇺🇸Lucile Packard Children's Hospital Stanford University, Palo Alto, California, United States
Drug Development Updates
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