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

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.

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 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