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CompletedNCT00293319Updated Aug 18, 2014

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

A Phase 2 interventional study of filgrastim and iobenguane I 131 in Neuroblastoma, sponsored by University of California, San Francisco. Completed at 3 sites in United States. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2014-08-18.

Sponsored by University of California, San Francisco · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
164
Allocation
Not applicable
Ages
1 Year and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Neuroblastoma

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Keywords

  • recurrent neuroblastoma
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In context

Neuroblastoma

625 studies on the registry are indexed under Neuroblastoma; 122 are open to participants now.

This study's enrollment of 164 is above the median of 32 across 475 interventional studies indexed under Neuroblastoma.

Browse Neuroblastoma studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Year and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
164 participants (actual)

Interventions

  • Biologicalfilgrastim
  • Radiationiobenguane I 131
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What researchers measure

Primary outcomes

  1. Ability of iodine I 131 metaiodobenzylguanidine to provide palliative therapy

  2. Acute and late toxicities

Secondary outcomes

  1. Disease and symptom responses

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Study locations

3 sites
  • UCSF Comprehensive Cancer Center
    San Francisco, California 94115, United States
  • University of Michigan Comprehensive Cancer Center
    Ann Arbor, Michigan 48109-0942, United States
  • Children's Hospital of Philadelphia
    Philadelphia, Pennsylvania 19104, United States
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References and documents

Publications

  • Matthay KK, Yanik G, Messina J, Quach A, Huberty J, Cheng SC, Veatch J, Goldsby R, Brophy P, Kersun LS, Hawkins RA, Maris JM. Phase II study on the effect of disease sites, age, and prior therapy on response to iodine-131-metaiodobenzylguanidine therapy in refractory neuroblastoma. J Clin Oncol. 2007 Mar 20;25(9):1054-60. doi: 10.1200/JCO.2006.09.3484. PubMed 17369569 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00293319
Lead sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)
Responsible party
Katherine Matthay (Professor, Department of Pediatrics, University of California, San Francisco) — Principal investigator
First posted
Feb 17, 2006
Start date
Apr 2005
Primary completion
Mar 2006
Completion
Mar 2006
Last update
Aug 18, 2014

Study contacts

Katherine K. Matthay, MD
study chair · University of California, San Francisco
John M. Maris, MD
Children's Hospital of Philadelphia
Robert Goldsby, MD
University of California, San Francisco
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

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