Feasibility of high-dose iodine-131-metaiodobenzylguanidine therapy for high-risk neuroblastoma preceding myeloablative chemotherapy and hematopoietic stem cell transplantation: a study protocol

Document Type: Others

Authors

1 Department of Pediatrics, School of Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, Japan

2 Department of Nuclear Medicine, School of Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, Japan

3 Innovative Clinical Research Center, Kanazawa University, Japan

Abstract

Objective(s): High-risk neuroblastoma is a childhood cancer with poor
prognosis despite modern multimodality therapy. Internal radiotherapy using
131I-metaiodobenzylguanidine (MIBG) is effective for treating the disease even if it is
resistant to chemotherapy. The aim of this study is to evaluate the safety and efficacy
of 131I-MIBG radiotherapy combined with myeloablative high-dose chemotherapy
and hematopoietic stem cell transplantation.
Methods: Patients with high-risk neuroblastoma will be enrolled in this study. A total
of 8 patients will be registered. Patients will receive 666 MBq/kg of 131I-MIBG and
after safety evaluation will undergo high-dose chemotherapy and hematopoietic stem
cell transplantation. Autologous and allogeneic stem cell sources will be accepted.
After engraftment or 28 days after hematopoietic stem cell transplantation, the safety
and response will be evaluated.
Conclusion: This is the first prospective study of 131I-MIBG with high-dose
chemotherapy and hematopoietic stem cell transplantation in Japan. The results will
be the basis of a future nationwide clinical trial.

Keywords

Main Subjects


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