TheranosticTrials.org

Clinical Trial · NCT00960739

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

Overview

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.

Sponsor

Unknown Organization

Phase

Phase 2

Contacts

Anne Sophie Defachelles, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT00960739

Drug / Compound

MIBG

Isotope(s):
Target(s):
  • NET
Ligand Class: Small Molecules

Eligibility

Inclusion

  • Metastatic disease that is recurrent or refractory to induction therapy
  • No other contraindicated biologic therapy that cannot be discontinued for ≥ 4 courses during MIBG therapy
  • Histologically confirmed neuroblastoma
  • No HIV positivity
  • At least 3 weeks since prior chemotherapy (6 weeks for mitomycin C or nitrosoureas)
  • ANC ≥ 1,000/mm³
  • No toxicity to other organs ≥ NCI-CTCAE v3.0 grade 2
  • No other debilitating disease
  • WHO performance status (PS) 0-1 OR Lansky PS 70-100%
  • Autologous bone marrow or peripheral blood stem cells must be available
  • Platelet count ≥ 100,000/mm³
  • No prior hypersensitivity to topotecan or its excipients
  • More than 30 days since prior external-beam radiation (6 weeks if cranio-spinal, abdominal, or pulmonary)
  • Life expectancy \> 2 months
  • Primary or metastatic tumor target with MIBG fixation (tumor/soft tissue) \> 2
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

Exclusion

  • Other invalidating pathology
  • Hypersensibility to Topotecan
  • Pregnancy or breastfeeding women
  • Concomitant treatment interfering with MIBG
  • Participation to another phase I,II or III clinical trial
  • HIV positive