Iodobenzylguanidine Meta-I131 and Topotecan in Treating Young Patients With Refractory or Relapsed Metastatic Neuroblastoma
Recruitment status was Recruiting
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:||Allocation: Non-Randomized
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 [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
|Study Start Date:||January 2009|
|Estimated Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
- 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||Recruiting|
|Lille, France, 59020|
|Contact: Anne-Sophie Defachelles 33-32-029-5959|
|Principal Investigator:||Anne-Sophie Defachelles||Centre Oscar Lambret|