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A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or ALK Inhibitor Therapy Added to Intensive Therapy for Children With Newly Diagnosed High-Risk Neuroblastoma (NBL)

  • Protocol Number: 201805206
  • Principal Investigator: Huang, Frederick
  • Cancer Types: Siteman Kids- Pediatrics

Learn more about this study at: clinicaltrials.gov

For more information on this trial, contact us here:

Phone
800-600-3606
Email
[email protected]

Brief 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.

Protocol Interventions

Procedure: Autologous Hematopoietic Stem Cell Transplantation, Procedure: Biospecimen Collection, Procedure: Bone Marrow Aspiration and Biopsy, Drug: Carboplatin, Drug: Cisplatin, Procedure: Computed Tomography, Drug: Cyclophosphamide, Drug: Dexrazoxane Hydrochloride, Biological: Dinutuximab, Drug: Doxorubicin Hydrochloride, Procedure: Echocardiography, Drug: Etoposide Phosphate, Radiation: External Beam Radiation Therapy, Radiation: Iobenguane I-123, Drug: Isotretinoin, Drug: Lorlatinib, Procedure: Multigated Acquisition Scan, Procedure: Positron Emission Tomography, Biological: Sargramostim, Procedure: Therapeutic Conventional Surgery, Drug: Thiotepa, Drug: Topotecan Hydrochloride