High-Risk Neuroblastoma Chemotherapy Without G-CSF

You may be eligible if

• Age greater than 12 months and less than 18 years old at diagnosis
• Newly diagnosed neuroblastoma or ganglioneuroblastoma as verified by histology and/or demonstration of tumor cells in bone marrow with elevated urinary catecholamine metabolites
• Must meet criteria for High Risk disease
• * Patients with International Neuroblastoma Staging System (INSS) stage 4 disease are eligible with the following: MYCN gene amplification (greater than four-fold increase in MYCN signals as compared to reference signals), regardless of age or additional biologic features, Age greater than 18 months ( greater than 547 days) regardless of biologic features, Age 12 -18 months (365 - 547 days) with any of the following unfavorable biologic features (unfavorable pathology and/or DNA index = 1) or any biologic feature that is indeterminate/unsatisfactory/unknown
• * Patients with INSS stage 3 disease are eligible with the following: MYCN amplification, regardless of age or additional biologic features, Age greater than 18 months ( greater than 547 days) with unfavorable pathology, regardless of MYCN status
• * Patients with INSS stage 2a/2b with MYCN amplification regardless of age or additional biologic features
• * Patients greater than or equal to 365 days initially diagnosed with INSS stage 1 or 2 who progressed to a stage 4 without interval chemotherapy
• Patients may have had no prior systemic therapy except: Localized emergency radiation to sites of life threatening or functioning disease, No more than 1 cycle of chemotherapy according to low or intermediate risk regimens prior to determination of MYCN amplification and histology, as long as the patient DID NOT receive any type of granulocyte colony stimulating factor (G-CSF) as part of that therapy.
• Patients must have adequate hematopoietic function defined as: Absolute neutrophil count (ANC) greater than or equal to 750/μL, Platelet count greater than or equal to 75,000/μL, The above criteria do not have to be met if the patient has bone marrow involvement of tumor.
• Patients must have adequate liver function defined as: Direct bilirubin less than or equal to 1.5 mg/dL or total bilirubin ≤ 1.5 mg/dL, aspartate aminotrasnferase (AST) and alanine aminotransferase (ALT) less than or equal to10 x upper limit of normal for age
• Patients must have adequate renal function as defined as: Creatinine clearance (CrCl) or radioisotope glomerular filtration rate (GFR) greater than or equal to 70 mL/min/.73 m2 OR A serum creatinine based on age/gender.
• Patients must have adequate cardiac function as defined as: Shortening fraction of greater than or equal to 27 % by echocardiogram, or Ejection fraction of greater than or equal to 50 % by radionuclide angiogram
• Patients who are pregnant or lactating
• Patients who have received G-CSF since the time of diagnosis of the current disease