Neuroblastoma Maintenance Therapy Trial

Eligibility Criteria

• * All patients must have a pathologically confirmed diagnosis of neuroblastoma, \< 30.99 years of age and classified as high risk at the time of diagnosis. Exception: patients who are initially diagnosed as non-high-risk neuroblastoma, but later converted (and/or relapsed) to high risk neuroblastoma are also eligible.
• * All patients must be in complete remission (CR):
• 1. No evidence of residual disease on scan
• 2. No evidence of disease metastatic to bone marrow.
• * Specific Criteria by Stratum:
• * Pre-enrollment tumor survey: Prior to enrollment on this study, a determination of mandatory disease staging must be performed:
• * Tumor imaging studies including
• * Bilateral bone marrow aspirates and biopsy
• * This disease assessment is required for eligibility and preferably should be done within 2 weeks prior to enrollment, but must be done within a maximum of 4 weeks before enrollment.
• * Timing from prior therapy:
• * Patients must have a Lansky or Karnofsky Performance Scale score of \> 50% and patients must have a life expectancy of ≥ 2 months.
• * All clinical and laboratory studies for organ functions to determine eligibility must be performed within 7 days prior to enrollment unless otherwise indicated below.
• * Patients must have adequate organ functions at the time of registration:
• * Hematological: Total absolute phagocyte count ≥1000/μL
• * Liver: Subjects must have adequate liver function
• * Renal: Adequate renal function
• * Females of childbearing potential must have a negative pregnancy test. Patients of childbearing potential must agree to use an effective birth control method. Female patients who are lactating must agree to stop breast-feeding.
• * Written informed consent in accordance with institutional and FDA (food and drug administration) guidelines must be obtained from all subjects (or patients' legal representative).
• * BSA (Body Surface Area) of \<0.25 m2.
• * Investigational Drugs: Subjects who are currently receiving another investigational drug are excluded from participation.
• * Anti-cancer Agents: Subjects who are currently receiving other anticancer agents are not eligible. Subjects must have fully recovered from hematological and bone marrow suppression effects of prior chemotherapy.
• * Infection: Subjects who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.
• * Subjects who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal, should be excluded.