ABT-751 in Treating Children With Neuroblastoma That Has Relapsed or Not Responded to Previous Treatment

Inclusion Criteria

• Histologically or cytologically confirmed neuroblastoma meeting the following criteria:
• Refractory or relapsed disease
• No curative treatment option and no additional therapy proven to prolong survival with an acceptable quality of life is available
• Evidence of disease progression (enlargement of existing measurable tumors or the appearance of new tumors) during prior treatment OR biopsy-proven viable neuroblastoma if stable disease but refractory to prior treatment
• Previously irradiated soft tissue or bony lesion must meet ≥ 1 of the following criteria:
• Viable neuroblastoma determined by biopsy ≥ 6 weeks after radiation therapy
• Growth in the lesion determined by CT scan or MRI
• Measurable or evaluable disease
• Measurable disease is defined as ≥ 20 mm in ≥ 1 dimension by MRI, CT scan, or x-ray OR ≥ 10 mm in ≥ 1 dimension by spiral CT scan
• Evaluable disease is defined as iodine I 123 metaiodobenzylguanidine (^123I MIBG)-positive lesion at ≥ 1 site
• Must not have measurable disease by CT scan or MRI
• No elevated urinary catecholamines and/or bone marrow evidence of tumor, without measurable or evaluable disease by imaging modalities (CT scan, MRI, or ^123I MIBG)
• Karnofsky performance status (PS) 50-100% (> 16 years of age) OR Lansky PS 50-100% (≤ 16 years of age)
• Life expectancy ≥ 8 weeks
• Hemoglobin ≥ 7.5 g/dL (transfusions allowed)
• Absolute neutrophil count > 250/mm³
• Platelet count > 25, 000/mm³ (without platelet transfusion support for ≥ 7 days)
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• ALT 50% pelvis, craniospinal, or total-body radiation)
• More than 4 months since prior allogeneic stem cell transplantation (SCT) (2 months for autologous SCT) and recovered
• Infusion of autologous peripheral blood mononuclear cells without high-dose chemotherapy or preparative regimen is not considered SCT
• More than 30 days since prior investigational drug therapy
• More than 30 days since prior immunotherapy (monoclonal antibody therapy or vaccine therapy)
• More than 1 week since prior growth factor treatment
• No other concurrent anticancer agents, including chemotherapy, immunomodulating agents, or biologic therapy (retinoids)
• No concurrent radiation therapy, including palliative radiation therapy
• No concurrent treatment for graft-vs-host disease
• No concurrent epoetin alfa, sargramostim (GM-CSF), or interleukin-11