TheranosticTrials.org

Clinical Trial · NCT00659984

N2007-01: Ultratrace™ Iobenguane I 131 in Patients With Relapsed/Refractory High-Risk Neuroblastoma

Overview

RATIONALE: Radioactive drugs, such as iodine I 131 metaiodobenzylguanidine (MIBG), may carry radiation directly to tumor cells and not harm normal cells. A bone marrow or peripheral stem cell transplant using stem cells from the patient may be able to replace blood-forming cells that were destroyed by I 131 MIBG. PURPOSE: This phase II trial is studying the side effects and best dose of iodine I 131 MIBG followed by a stem cell transplant in treating young patients with relapsed or refractory high-risk neuroblastoma.

Sponsor

Bivision Pharmaceuticals, Inc.

Phase

Phase 2

Contacts

Katherine K. Matthay, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT00659984

Eligibility

Inclusion

  • Patients must have a PBSC or bone marrow stem cell product available that meets study criteria. If they don't already have stem cells frozen away then they must be able to have a stem cell pheresis done to collect the necessary amount of stem cells for study entry and these stem cells must meet study criteria.
  • Patients must have high risk neuroblastoma and either have tumor left after treatment started at diagnosis or have had the tumor grow back (relapsed) after getting some treatment
  • * Patients must be at least one year and no more than 30 years of age when registered on this study.
  • Patients must an MIBG scan done and it must be positive for neuroblastoma.
  • Patients must have adequate heart, lung, liver, kidney and bone marrow function.

Exclusion

  • They are on dialysis for badly working kidneys or have other kidney problems.
  • They have other medical problems that could get much worse if they had this treatment.
  • They are pregnant or breast feeding.
  • They have tumor in the brain or spinal cord that is seen on a CT or MRI scan one month before starting treatment
  • * They have had a stem cell transplant using another person as the stem cell donor. (You can still be in the study if a previous transplant used your own stem cells)