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

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

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.

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