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Spots Global Cancer Trial Database for Iodobenzylguanidine Meta-I131 and Topotecan in Young Patients With Refractory or Relapsed Metastatic Neuroblastoma

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Trial Identification

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

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

Study ID: NCT00960739

Conditions

Neuroblastoma

Study Description

Brief 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.

Eligibility

Minimum Age: 1 Year

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Centre Oscar Lambret, Lille, , France

Centre Léon Bérard, Lyon, , France

Hôpital des Enfants, Toulouse, , France

Contact Details

Name: Anne Sophie Defachelles, MD

Affiliation: Centre Oscar Lambret

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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