NCT00960739

Iodobenzylguanidine Meta-I131 and Topotecan in Young Patients With Refractory or Relapsed Metastatic Neuroblastoma

Phase II Study of the Association of Iodobenzylguanidine Meta-I131 (I131 MIBG) and Topotecan in the Treatment of Refractory or Relapsed Metastatic Neuroblastoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Centre Oscar Lambret · Academic / Other
• Sex: All
• Age: 1 Year – 20 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Neuroblastoma

Interventions

Type	Name	Description
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)
PROCEDURE	Autologous hematopoietic stem cell transplantation	Hematopoietic stem cells are reinjected 10 days after the second injection of 131-iodine MIBG
RADIATION	iobenguane I 131	444 MBq / kg of 131-iodine MIBG is administered on day 1 with activity
RADIATION	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)

Timeline

• Start date: 2008-11-01
• Primary completion: 2016-03-01
• Completion: 2016-07-01
• First posted: 2009-08-18
• Last updated: 2016-08-08

Locations

3 sites across 1 country: France