131 I-MIBG in Treating Patients With Refractory or Relapsed Neuroblastoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00293319
Recruitment Status : Completed
First Posted : February 17, 2006
Last Update Posted : August 18, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Katherine Matthay, University of California, San Francisco

Brief Summary:

RATIONALE: Radioactive drugs, such as 131 I-MIBG, may carry radiation directly to tumor cells and not harm normal cells.

PURPOSE: This phase II trial is studying how well 131 I-MIBG works in treating patients with refractory or relapsed neuroblastoma.

Condition or disease Intervention/treatment Phase
Neuroblastoma Biological: filgrastim Radiation: iobenguane I 131 Phase 2

Detailed Description:



  • Determine if iodine I 131 metaiodobenzylguanidine can provide palliative therapy for patients with refractory or relapsed neuroblastoma.
  • Determine the acute and late toxicity of this regimen in these patients.


  • Determine disease and symptom responses of patients treated with this regimen.

OUTLINE: This is a compassionate use study.

Patients receive iodine I 131 metaiodobenzylguanidine IV over 2 hours. Beginning 10 days later, patients with low neutrophil counts receive filgrastim (G-CSF) subcutaneously until blood count recovers. Patients with stable or responding disease may receive a second dose of iodine I 131 metaiodobenzylguanidine at least 6 weeks after the first dose.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 164 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: I-Metaiodobenzylguanidine (I-MIBG) Therapy for Refractory Neuroblastoma, A Phase II Study
Study Start Date : April 2005
Actual Primary Completion Date : March 2006
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Neuroblastoma

Primary Outcome Measures :
  1. Ability of iodine I 131 metaiodobenzylguanidine to provide palliative therapy
  2. Acute and late toxicities

Secondary Outcome Measures :
  1. Disease and symptom responses

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Original diagnosis of neuroblastoma based on 1 of the following criteria:

    • Histopathology
    • Elevated urine catecholamines with typical tumor cells in the bone marrow
  • Refractory or relapsed disease, meeting 1 of the following criteria:

    • Failure to respond to standard therapy (e.g., combination chemotherapy with or without radiotherapy and surgery)
    • Evidence of disease progression (i.e., any new lesion or an increase in size of > 25% of a pre-existing lesion) at any time
  • Evaluable disease by MIBG scan within 6 weeks of study entry


  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Negative pregnancy test
  • Bilirubin < 2 times normal
  • AST/ALT ≤ 10 times normal
  • Creatinine ≤ 2 mg/dL
  • Absolute neutrophil count* ≥ 750/mm^3 (transfusion independent)
  • Platelet count* ≥ 50,000/mm^3 (20,000/mm^3 if stem cells are available and platelet transfusion independent)
  • Hemoglobin* ≥ 10 g/dL (transfusion allowed)
  • No dyspnea at rest
  • No exercise intolerance
  • No oxygen requirement
  • No clinically significant cardiac dysfunction
  • No disease of any major organ system that would preclude study compliance
  • No active infection that meets grade 3 or 4 toxicity criteria NOTE: *Patients with granulocytopenia and/or thrombocytopenia due to tumor metastases to the bone marrow may be eligible at the discretion of the principal investigator


  • See Disease Characteristics
  • Recovered from prior therapy
  • At least 2 weeks since prior antitumor therapy
  • At least 3 months since prior radiotherapy to any of the following fields:

    • Craniospinal
    • Total abdominal
    • Whole lung
    • Total body
  • At least 1 day since prior cytokine therapy (e.g., filgrastim [G-CSF], sargramostim [GM-CSF], interleukin-6, or epoetin alfa)
  • Prior iodine I 131 metaiodobenzylguanidine allowed provided it was given more than 6 months ago AND patient has adequate hematopoietic stem cells available
  • No concurrent hemodialysis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00293319

United States, California
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of California, San Francisco
National Cancer Institute (NCI)
Study Chair: Katherine K. Matthay, MD University of California, San Francisco
OverallOfficial: John M. Maris, MD Children's Hospital of Philadelphia
OverallOfficial: Robert Goldsby, MD University of California, San Francisco

Publications of Results:
Responsible Party: Katherine Matthay, Professor, Department of Pediatrics, University of California, San Francisco Identifier: NCT00293319     History of Changes
Other Study ID Numbers: CDR0000454716
First Posted: February 17, 2006    Key Record Dates
Last Update Posted: August 18, 2014
Last Verified: August 2014

Keywords provided by Katherine Matthay, University of California, San Francisco:
recurrent neuroblastoma

Additional relevant MeSH terms:
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action