Iodobenzylguanidine Meta-I131 and Topotecan in Young Patients With Refractory or Relapsed Metastatic Neuroblastoma (MIITOP)
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.
Drug: Topotecan hydrochloride
Procedure: Autologous hematopoietic stem cell transplantation
Radiation: iobenguane I 131
Radiation: total-body irradiation
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Response rate [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: Up to 30 days after study treatment ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2008|
|Estimated Study Completion Date:||April 2016|
|Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Experimental: Topotecan / 131-iodine MIBG association
Drug: Topotecan hydrochloride
The topotecan hydrochloride is administered intravenously over five days to dose of 0.7 mg/ m²/day from day 1 to day 5 (first cycle), then from day 21 to day 25 (second cycle)
Other Name: TopotecanProcedure: Autologous hematopoietic stem cell transplantation
Hematopoietic stem cells are reinjected 10 days after the second injection of 131-iodine MIBG
Other Name: hematopoietic stem cell transplantationRadiation: iobenguane I 131
444 MBq / kg of 131-iodine MIBG is administered on day 1 with activityRadiation: total-body irradiation
the dose of total-body irradiation of 4 Gy is reached during the first cycle, the second cycle is canceled (131-iodine MIBG and Topotecan)
- 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) 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00960739
|Centre Oscar Lambret|
|Lille, France, 59020|
|Centre Léon Bérard|
|Lyon, France, 69373|
|Hôpital des Enfants|
|Toulouse, France, 31059|
|Principal Investigator:||Anne Sophie Defachelles, MD||Centre Oscar Lambret|