drugset / Trial / NCT03126916

Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)

NCT03126916

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2018-05-14
Primary completion
2030-09-30
Completion
2030-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Busulfan Small molecule Intravenous
Subject Carboplatin Small molecule Intravenous
Subject Lorlatinib Small molecule Oral
Subject Melphalan Small molecule Intravenous
Subject Vincristine Small molecule Intravenous
Background Cisplatin Other / unclassified Intravenous
Background Cyclophosphamide Other / unclassified Intravenous
Background Dexrazoxane Small molecule Intravenous
Background Dinutuximab Monoclonal antibody Intravenous
Background Doxorubicin Other / unclassified Intravenous
Background Etoposide Small molecule Intravenous
Background Isotretinoin Other / unclassified Oral
Background Thiotepa Other / unclassified Intravenous
Background Topotecan Small molecule Intravenous
Background sargramostim Protein / enzyme biologic Subcutaneous