Neuroblastoma Clinical Trial
Official title:
Phase II Study of the Association of Iodobenzylguanidine Meta-I131 (I131 MIBG) and Topotecan in the Treatment of Refractory or Relapsed Metastatic Neuroblastoma
RATIONALE: Radioactive drugs, such as iodobenzylguanidine meta-I131, may carry radiation
directly to tumor cells and not harm normal cells. Drugs used in chemotherapy, such as
topotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by
killing the cells or by stopping them from dividing. A stem cell transplant may be able to
replace the cells that were destroyed by iodobenzylguanidine meta-i131 and topotecan
hydrochloride.
PURPOSE: This phase II trial is studying the side effects of iodobenzylguanidine meta-I131
given together with topotecan hydrochloride and to see how well it works in treating young
patients with refractory or relapsed metastatic neuroblastoma.
OBJECTIVES:
Primary
- Determine the antitumor activity of iodobenzylguanidine meta-I131 (^131I-MIBG) and
topotecan in young patients with refractory or relapsed metastatic neuroblastoma.
Secondary
- Determine the hematological and extra-hematological toxicities of this regimen.
OUTLINE: This is a multicenter study.
During the 21 days before treatment begins, autologous peripheral blood stem cells (PBSC)
are collected.
Patients receive topotecan hydrochloride IV over 30 minutes daily on days 1-5 and
iodobenzylguanidine meta-^131I IV over 2 hours on day 1. Treatment repeats every 21 days for
2 courses. Patients also undergo total-body irradiation.
On day 10 of the second course, autologous PBSC are reinfused.
After completion of study therapy, patients are followed at 6 and 12 months.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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