drugset / Trial / NCT00070200

Induction Chemotherapy Using Cyclophosphamide and Topotecan in Treating Patients Who Are Undergoing Autologous Peripheral Stem Cell Transplantation for Newly Diagnosed or Progressive Neuroblastoma

NCT00070200

NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy, such as topotecan and cyclophosphamide, use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: This phase I trial is studying the side effects of induction chemotherapy using cyclophosphamide and topotecan in treating patients who are undergoing surgery and autologous stem cell transplantation followed by radiation therapy for newly diagnosed or progressive neuroblastoma.

Timeline

Start
2004-03
Primary completion
2006-09
Completion
2013-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 13.3 mg/kg Intravenous
Subject Cyclophosphamide Other / unclassified 400 mg/m2 Intravenous
Subject Topotecan Small molecule 0.04 mg/kg Intravenous
Subject Topotecan Small molecule 1.2 mg/m2 Intravenous
Background Cisplatin Other / unclassified Intravenous
Background Doxorubicin Other / unclassified Intravenous
Background Etoposide Small molecule Intravenous
Background Isotretinoin Other / unclassified Oral
Background Melphalan Small molecule Intravenous
Background Vincristine Small molecule Intravenous
Background filgrastim Protein / enzyme biologic 5 ug/kg Subcutaneous

Indications