Induction Chemotherapy without G-CSF in Treating Participants with High-Risk Neuroblastoma

Inclusion Criteria

• 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 amplification (greater than four-fold increase in MYCN signals as compared to reference signals), regardless of age or additional biologic features ** Age >18 months (> 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 deoxyribonucleic acid [DNA] index =1) or any biologic feature that is indeterminate/unsatisfactory/unknown
• Must meet criteria for high risk disease * Patients with INSS stage 3 disease are eligible with the following ** MYCN amplification, regardless of age or additional biologic features ** Age >18 months (> 547 days) with unfavorable pathology, regardless of MYCN status
• Must meet criteria for high risk disease * Patients with INSS stage 2a/2b with MYCN amplification regardless of age or additional biologic features
• Must meet criteria for high risk disease * Patients ≥ 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 granulocyte colony-stimulating factor (G-CSF) as part of that therapy
• Absolute neutrophil count (ANC) ≥ 750/uL * The above criteria do not have to be met if the patient has bone marrow involvement of tumor
• Platelet count ≥ 75,000/uL * The above criteria do not have to be met if the patient has bone marrow involvement of tumor
• Direct bilirubin ≤ 1.5 mg/dL or total bilirubin ≤ 1.5 mg/dL
• Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) ≤ 10 x upper limit of normal for age
• Creatinine clearance (CrCl) or radioisotope glomerular filtration rate (GFR) ≥ 70 mL/min/1.73 m^2 OR a serum creatinine based on age/gender as follows: * 1 month to < 6 months (male) 0.4 (female) 0.4 * 6 months to < 1 year (male) 0.5 (female) 0.5 * 1 to < 2 years (male) 0.6 (female) 0.6 * 2 to < 6 years (male) 0.8 (female) 0.8 * 6 to < 10 years (male) 1 (female) 1 * 10 to < 13 years (male) 1.2 (female) 1.2 * 13 to < 16 years (male) 1.5 (female) 1.4 * ≥ 16 years (male) 1.7 (female) 1.4
• Patients must have adequate cardiac function as defined as: * Shortening fraction of ≥ 27% by echocardiogram, or * Ejection fraction of ≥ 50% by radionuclide angiogram

Exclusion Criteria

• Patients who do not meet inclusion criteria
• Patients who are pregnant or lactating
• Patients who have received G-CSF since the time of diagnosis of the current disease