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

You may be eligible if

• 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