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 \< 5 times ULN
• •Creatinine normal for age and gender as follows: OR creatinine clearance or radioisotope glomerular filtration rate ≥ 60 mL/min
• •* No greater than 0.4 mg/dL (≤ 5 months)
• •* No greater than 0.5 mg/dL (6 months-11 months)
• •* No greater than 0.6 mg/dL (1 year-23 months)
• •* No greater than 0.8 mg/dL (2 years-5 years)
• •* No greater than 1.0 mg/dL (6 years-9 years)
• •* No greater than 1.2 mg/dL (10 years-12 years)
• •* No greater than 1.4 mg/dL (13 years and over \[female\])
• •* No greater than 1.5 mg/dL (13 years to 15 years \[male\])
• •* No greater than 1.7 mg/dL (16 years and over \[male\])
• •Shortening fraction ≥ 27% by echocardiogram
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective double-barrier contraception during and for 90 days after completion of study treatment
• •Seizure disorder allowed if controlled and receiving anticonvulsants
• •Neurologic toxicity from prior therapy or tumor involvement ≤ grade 2
• •No evidence of active graft-vs-host disease
• •No allergy to sulfa-containing medications
• •No known HIV positivity
• •No clinically significant unrelated systemic illness (e.g., serious infection) that would limit study compliance
• •Concurrent filgrastim (G-CSF) allowed if medically indicated
• •Recovered from all prior therapy
• •No prior ABT-751
• •More than 2 weeks since prior myelosuppressive chemotherapy
• •More than 7 days since prior anticancer biologic agents (e.g., retinoids)
• •More than 4 weeks since prior palliative radiation therapy (small port) or therapeutic \^123I MIBG
• •More than 6 weeks since prior substantial radiation therapy (\> 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