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 Primary Completion Date:||January 2016 (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
|Contact: Anne Sophie DEFACHELLES, MD||33 3 20 29 59 firstname.lastname@example.org|
|Centre Oscar Lambret||Recruiting|
|Lille, France, 59020|
|Contact: Aurélie TESSIER, CRA 33 3 20295935|
|Principal Investigator: Anne Sophie DEFACHELLES, MD|
|Centre Léon Bérard||Recruiting|
|Lyon, France, 69373|
|Contact: Maryline HERBET, CRA 33 4 78 78 26 82 Maryline.HERBET@lyon.unicancer.fr|
|Principal Investigator: Christophe BERGERON, MD|
|Centre Hospitalier Universitaire - Hôpital Mère enfants||Withdrawn|
|Nantes, France, 44000|
|Hôpital des Enfants||Recruiting|
|Toulouse, France, 31059|
|Contact: Nathalie COUTEAU, CRA 33 5 34 55 86 11|
|Principal Investigator: Hervé RUBIE, MD|
|Principal Investigator:||Anne Sophie Defachelles, MD||Centre Oscar Lambret|