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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Neuroblastoma

Intervention / Treatment
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* Biological: filgrastim
* Radiation: iobenguane I 131


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: filgrastim|nan|
|Radiation: iobenguane I 131|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability of iodine I 131 metaiodobenzylguanidine to provide palliative therapy |  |  | 
| Acute and late toxicities |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease and symptom responses |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent neuroblastoma