Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma
Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma
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Clinical Trial Information
Trial Contact: Doyle, Katherine M; Parker, Melanie; Armatti, Julie M
Trial Phone: 3218412008 ; 321-843-1036 ; 321-843-5284
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IRB No: ANBL2131
Protocol Abbrev: ANBL2131
Principal Investigator: Jaime M Salcedo Varela, MD
Phase: Drug: Phase III
Age Group: Adult; Pediatric
Treatment: Procedure: Biospecimen Collection, Procedure: Bone Marrow Aspiration, Procedure: Bone Marrow Biopsy, Drug: Carboplatin, Drug: Cisplatin, Procedure: Computed Tomography, Drug: Cyclophosphamide, Biological: Dinutuximab, Drug: Doxorubicin, Drug: Etoposide, Procedure: FDG-Positron Emission Tomography and Computed Tomography Scan, Procedure: Hematopoietic Cell Transplantation, Drug: Irinotecan, Drug: Isotretinoin, Procedure: Leukapheresis, Procedure: Magnetic Resonance Imaging, Drug: Melphalan, Radiation: Radiation Therapy, Procedure: Radionuclide Imaging, Other: Survey Administration, Drug: Temozolomide, Drug: Thiotepa, Drug: Topotecan, Procedure: Tumor Resection, Drug: Vincristine
ClinicalTrials.gov ID: NCT06172296
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Objective
To determine if the event-free survival (EFS) of patients with newly diagnosed high-risk neuroblastoma assigned to early chemoimmunotherapy during Induction differs from that of patients who are not assigned to treatment that includes early chemoimmunotherapy.
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Key Eligibility
≤ 30 years at the time of initial diagnosis with high-risk disease, Must have a diagnosis of neuroblastoma (NBL) or ganglioneuroblastoma (nodular) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamines, Patients must have a BSA ≥ 0.25 m^2
