drugset / Trial / NCT00670410

Autologous Transplant Followed by Allogeneic Transplant for High Risk Neuroblastoma

NCT00670410

Phase 1 Terminated 15 enrolled Columbia University
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Neuroblastoma is a malignant tumor of the sympathetic nervous system. It is the second most common malignant tumor of childhood. Although modest advances have been made over the past 20 years children with high-risk neuroblastoma continue to have an unsatisfactory long-term survival. This study will administer induction chemotherapy followed by high-dose (myeloablative) chemotherapy with autologous stem cell transplantation, followed by radiation therapy, then immunotherapy with a non myeloablative allogeneic stem cell transplant for treatment of neuroblastoma. The purpose of this clinical research trial is to study the feasibility of giving immunotherapy with a non-myeloablative allogeneic transplant (NAT/AlloSCT), following myeloablative therapy and autologous stem cell transplant (MAT/AutoSCT). This study will also determine the side effects as well as the response rate for each group of patients (treatment arm).

Timeline

Start
2003-11
Primary completion
2010-12
Completion
2010-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Busulfan Small molecule 3.2 mg/kg Intravenous
Subject Busulfan Small molecule 4 mg/kg Intravenous
Subject Fludarabine Small molecule 1 mg/kg Intravenous
Subject Fludarabine Small molecule 30 mg/m2 Intravenous
Subject Thymoglobulin Protein / enzyme biologic

Indications