Decitabine, Doxorubicin, and Cyclophosphamide in Treating Children With Relapsed or Refractory Solid Tumors or Neuroblastoma

Inclusion Criteria

• •Histologically confirmed diagnosis of either of the following:
• •* Solid tumor (part A)
• •* No lymphoma
• •* Neuroblastoma (part B)
• •* Original diagnosis may be based on elevated urine vanillylmandelic acid (VMA) and homovanillic acid (HVA) and bone marrow examination
• •* Accessible disease by bone marrow aspirate or tumor biopsy
• •* No laparotomy, thoracotomy, endoscopy, or craniotomy for biopsy
• •No known curative therapy OR therapy proven to prolong survival with an acceptable quality of life available
• •No known brain or spinal cord metastases
• •No CNS tumors
• •Performance status - Karnofsky 50-100% (patients 11 to 21 years of age)
• •Performance status - Lansky 50-100% (patients ≤ 10 years of age)
• •Parts A and B without bone marrow infiltration:
• •* Absolute neutrophil count ≥ 1,000/mm\^3
• •* Platelet count ≥ 100,000/mm\^3 (transfusion independent)
• •Part B with bone marrow infiltration (i.e., tumor metastatic to bone marrow with granulocytopenia, anemia, and/or thrombocytopenia):
• •* Absolute neutrophil count ≥ 750/mm\^3
• •* Platelet count ≥ 50,000/mm\^3 (transfusion independent)
• •Hemoglobin ≥ 8.0 g/dL (transfusion allowed)
• •No sickle cell anemia
• •Bilirubin ≤ 1.5 mg/dL
• •ALT ≤ 5 times upper limit of normal
• •No significant hepatic dysfunction that would compromise the tolerability of decitabine or interfere with study procedures or results
• •Creatinine based on age as follows:
• •* ≤ 0.8 mg/dL (5 years of age and under)
• •* ≤ 1.0 mg/dL (6 to 10 years of age)
• •* ≤ 1.2 mg/dL (11 to 15 years of age)
• •* ≤ 1.5 mg/dL (16 to 21 years of age)
• •Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min
• •No significant renal dysfunction that would compromise the tolerability of decitabine or interfere with study procedures or results
• •Shortening fraction ≥ 28% by echocardiogram
• •Ejection fraction of ≥ 45% by MUGA
• •No significant pulmonary dysfunction that would compromise the tolerability of decitabine or interfere with study procedures or results
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •No prior allergic reaction attributed to compounds of similar chemical or biological composition to agents used in this study
• •No uncontrolled serious infection
• •No significant end-organ dysfunction that would compromise the tolerability of decitabine or interfere with study procedures or results
• •Recovered from prior immunotherapy
• •At least 7 days since prior biologic therapy
• •More than 1 week since prior growth factor therapy (2 weeks for pegfilgrastim)
• •More than 2 weeks since prior epoetin alfa
• •At least 6 months since prior autologous stem cell transplantation
• •At least 6 months since prior allogeneic bone marrow transplantation
• •* Patients must have full organ recovery and no evidence of graft-versus-host disease
• •No concurrent immunomodulating agents
• •No concurrent immunotherapy
• •No concurrent biologic therapy
• •No concurrent epoetin alfa
• •Recovered from prior chemotherapy
• •More than 2 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas)
• •Prior total lifetime cumulative anthracycline dose ≤ 450 mg/m\^2 of doxorubicin or equivalent
• •No other concurrent chemotherapy
• •No concurrent hydroxyurea
• •Recovered from prior radiotherapy
• •More than 2 weeks since prior local palliative small port radiotherapy
• •More than 6 months since prior substantial bone marrow irradiation (e.g., cranio-spinal irradiation, total body irradiation, or hemi-pelvic irradiation)
• •No concurrent radiotherapy
• •No other concurrent anticancer therapy
• •No other concurrent investigational agents
• •Concurrent oral iron supplementation for patients with a known iron deficiency or a microcytic hypochromic anemia allowed