N2001-03: CEP-701 in Treating Young Patients With Recurrent or Refractory High-Risk Neuroblastoma

DISEASE CHARACTERISTICS: Diagnosis of neuroblastoma confirmed by at least 1 of the following: Histology Demonstrates clumps of tumor cells in the bone marrow with elevated urinary catecholamine metabolites Recurrent or resistant/refractory disease Neuroblastoma metastatic to the bone marrow with granulocytopenia, anemia, and/or thrombocytopenia allowed High-risk disease Patients in first response after completion of a prior front-line myeloablative regimen OR who were medically ineligible to receive a front-line myeloablative regimen must meet at least 1 of the following criteria: Viable neuroblastoma determined by biopsy of a persistent lesion as seen on CT scan, MRI, or metaiodobenzylguanidine (MIBG) scan If lesion was irradiated, biopsy must be performed at least 4 weeks after completion of prior radiotherapy Morphologic evidence of tumor in bone marrow Second or greater response (without histologic confirmation) allowed Meets at least 1 of the following criteria: At least 1 unidimensionally measurable lesion on CT scan, MRI, or X-ray At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan MIBG scan with positive uptake at a minimum of 1 site Bone marrow with tumor cells on routine morphology (not by NSE staining only) of bilateral aspirate and/or biopsy AND/OR at least 5 tumor cells/10^6 mononuclear cells in the bone marrow by immunocytologic analysis of 2 consecutive bone marrows performed at least 1 day but no more than 4 weeks apart PATIENT CHARACTERISTICS: Age 21 and under at diagnosis Performance status Karnofsky 50-100% (for patients > 16 years of age) Lansky 50-100% (for patients ≤ 16 years of age) Life expectancy More than 2 months Hematopoietic See Disease Characteristics Absolute neutrophil count ≥ 1,000/mm^3 Platelet count ≥ 50,000/mm^3 (transfusion independent) Hemoglobin ≥ 8.0 g/dL (red blood cell transfusions allowed) Hepatic ALT and AST ≤ 3.0 times upper limit of normal (ULN) Total bilirubin ≤ 1.5 times ULN Renal Creatinine ≤ 1.5 times normal OR Creatinine clearance or radioisotope glomerular filtration rate ≥ 60 mL/min Cardiovascular Ejection fraction ≥ 50% by echocardiogram or MUGA OR Fractional shortening ≥ 28% or above lower limit of normal by echocardiogram Pulmonary Lung function normal No dyspnea at rest No exercise intolerance No supplemental oxygen requirement Other Not pregnant Negative pregnancy test Fertile patients must use effective contraception No uncontrolled infection No other concurrent illness that would preclude study treatment PRIOR CONCURRENT THERAPY: Biologic therapy See Chemotherapy At least 2 weeks since prior biologic or non-myelosuppressive therapy and recovered More than 7 days since prior growth factors No prior allogeneic stem cell transplantation AND no extensive chronic graft-versus-host disease No concurrent growth factors except filgrastim (G-CSF) or sargramostim (GM-CSF) administered for neutropenia lasting for more than 7 days or for confirmed or clinical septicemia associated with neutropenia Chemotherapy At least 3 months since prior myeloablative chemotherapy with stem cell transplantation At least 2 weeks since prior chemotherapy and recovered Endocrine therapy No concurrent corticosteroid therapy except replacement therapy for adrenal insufficiency or treatment for increased intracranial pressure Radiotherapy See Disease Characteristics Recovered from prior radiotherapy At least 6 weeks since prior therapeutic-dose MIBG At least 6 weeks since prior craniospinal or other radiotherapy involving significant bone marrow (i.e., total pelvis or total abdomen) At least 4 weeks since prior radiotherapy to any site biopsied At least 2 weeks since prior local palliative radiotherapy (small port) Surgery Not specified Other No prior CEP-701 No concurrent administration of any of the following CYP3A4 inhibitors: Cyclosporine Clotrimazole Ketoconazole Erythromycin Clarithromycin Troleandomycin HIV protease inhibitors Nefazodone Itraconazole Voriconazole