TheranosticTrials.org

Clinical Trial · NCT00083135

N2000-01: Double Infusion of Iodine I 131 Metaiodobenzylguanidine Followed by Autologous Stem Cell Transplantation

Overview

RATIONALE: Giving iodine I 131 metaiodobenzylguanidine (\^131I-MIBG) may kill neuroblastoma cells by delivering radiation directly to the tumor. A stem cell transplant using the patient's stem cells may be able to replace blood-forming cells destroyed by radiation therapy. PURPOSE: This phase I trial is studying the side effects and best dose of a double infusion of \^131I-MIBG followed by autologous stem cell transplantation in treating patients with refractory neuroblastoma.

Sponsor

Unknown Organization

Phase

Phase 1

Contacts

John M. Maris, MD (PRINCIPAL_INVESTIGATOR)

Gregory Yanik, MD (PRINCIPAL_INVESTIGATOR)

Katherine K. Matthay, MD (STUDY_CHAIR)

ClinicalTrials.gov

NCT00083135

Drug / Compound

metaiodobenzylguanidine

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

Eligibility

Inclusion

  • Diagnosis of neuroblastoma
  • High-risk disease
  • CD34-positive selected PBSC products are not allowed
  • Glomerular filtration rate OR 12-hour creatinine clearance ≥ 60 mL/min/1.73m\^2Cardiovascular
  • Prior re-induction therapy for recurrent tumor allowed

Exclusion

  • No prior \^131I-MIBGSurgery