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131 I-MIBG in Treating Patients With Refractory or Relapsed Neuroblastoma
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: UCSF Helen Diller Family Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00293319
  Purpose

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 Intervention Phase
Neuroblastoma
Drug: filgrastim
Drug: iodine I 131 metaiodobenzylguanidine
Phase II

MedlinePlus related topics: Cancer Neuroblastoma
Drug Information available for: Filgrastim Iodine Cadexomer iodine Sodium iodide I 131 3-Iodobenzylguanidine Iobenguane
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: I-Metaiodobenzylguanidine (I-MIBG) Therapy for Refractory Neuroblastoma, A Phase II Study

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Ability of iodine I 131 metaiodobenzylguanidine to provide palliative therapy [ Designated as safety issue: No ]
  • Acute and late toxicities [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Disease and symptom responses [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: April 2005
Detailed Description:

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00293319

Locations
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
UCSF Helen Diller Family Comprehensive Cancer Center
Investigators
Study Chair: Katherine K. Matthay, MD UCSF Helen Diller Family Comprehensive Cancer Center
Investigator: John M. Maris, MD Children's Hospital of Philadelphia
Investigator: Robert Goldsby, MD UCSF Helen Diller Family Comprehensive Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Study ID Numbers: CDR0000454716, UCSF-05161, UCSF-00161
Study First Received: February 16, 2006
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00293319  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent neuroblastoma

Study placed in the following topic categories:
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
3-Iodobenzylguanidine
Neoplasms, Germ Cell and Embryonal
Iodine
Neuroepithelioma
Neuroectodermal Tumors, Primitive, Peripheral
Recurrence
Neuroblastoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Neoplasms, Nerve Tissue
Enzyme Inhibitors
Neoplasms, Neuroepithelial
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009