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

Inclusion 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