Safety Study for Refractory or Relapsed Neuroblastoma With DFMO Alone and in Combination With Etoposide

Inclusion Criteria

• •Age: 0-21 years at the time of diagnosis.
• •Diagnosis: Histologic verification at either the time of original diagnosis or relapse of neuroblastoma.
• •Disease Status: Refractory or relapsed neuroblastoma
• •Measurable disease, including at least one of the following:
• •Measurable tumor \>10mm by CT or MRI A positive MIBG and abnormal urinary catecholamine levels Positive bone marrow biopsy/aspirate.
• •Current disease state must be one for which there is currently no known curative therapy.
• •A negative urine pregnancy test is required for female subjects of child bearing potential (onset of menses or ≥13 years of age).
• •Patients without bone marrow metastases must have an ANC \> 500/μl and platelet count \>50,000/μl
• •Organ Function Requirements Subjects must have adequate liver function as defined by AST or ALT \<10x normal Serum bilirubin must be ≤ 2.0 mg/dl Serum creatinine must be ≥ 1.5 mg/dl
• •Informed Consent: All subjects and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines