Phase II Study of the Association of Iodobenzylguanidine Meta-I131 (I131 MIBG) and Topotecan in the Treatment of Refractory or Relapsed Metastatic Neuroblastoma
- Determine the antitumor activity of iodobenzylguanidine meta-I131 (^131I-MIBG) and
topotecan in young patients with refractory or relapsed metastatic neuroblastoma.
- 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)
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.
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Centre Oscar Lambret