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I-Metaiodobenzylguanidine (I-MIBG) Therapy for Refractory Neuroblastoma, A Phase II Study

Phase 2
1 Year
Open (Enrolling)

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Trial Information

I-Metaiodobenzylguanidine (I-MIBG) Therapy for Refractory Neuroblastoma, A Phase II Study



- 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.

Inclusion Criteria


- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Ability of iodine I 131 metaiodobenzylguanidine to provide palliative therapy

Safety Issue:


Principal Investigator

Katherine K. Matthay, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Francisco


United States: Federal Government

Study ID:




Start Date:

April 2005

Completion Date:

Related Keywords:

  • Neuroblastoma
  • recurrent neuroblastoma
  • Neuroblastoma



University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Children's Hospital of Philadelphia Philadelphia, Pennsylvania  19104
UCSF Comprehensive Cancer Center San Francisco, California  94115