drugset / Trial / NCT01175356

Induction Therapy Including 131 I-MIBG and Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma Undergoing Stem Cell Transplant, Radiation Therapy, and Maintenance Therapy With Isotretinoin

NCT01175356

NaSingle-groupOpen-labelTreatment

Summary

This pilot clinical trial studies induction therapy followed by iobenguane I 131 and chemotherapy in treating patients with newly diagnosed high-risk neuroblastoma undergoing stem cell transplant, radiation therapy, and maintenance therapy with isotretinoin. Radioisotope therapy, such as iobenguane I 131, releases radiation that kills tumor cells. Drugs used in chemotherapy, such as carboplatin, etoposide phosphate, busulfan, and melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. A peripheral stem cell transplant may be able to replace blood-forming cells that are destroyed by iobenguane I 131 and chemotherapy. Giving radioisotope therapy, chemotherapy, and peripheral stem cell transplant may kill more tumor cells.

Timeline

Start
2011-12-21
Primary completion
2016-09-28
Completion
2025-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject 131I-MIBG Protein / enzyme biologic 12 unknown Intravenous
Subject 131I-MIBG Protein / enzyme biologic 15 unknown Intravenous
Subject 131I-MIBG Protein / enzyme biologic 18 unknown Intravenous
Subject Busulfan Small molecule Intravenous
Subject Cisplatin Other / unclassified Intravenous
Subject Cyclophosphamide Other / unclassified Intravenous
Subject Doxorubicin Other / unclassified Intravenous
Subject Etoposide Small molecule Intravenous
Subject Isotretinoin Other / unclassified Oral
Subject Melphalan Small molecule Intravenous
Subject Topotecan Small molecule Intravenous
Subject Vincristine Small molecule Intravenous