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Investigator(s):
Elizabeth Fox, M.D. Principal Investigator Phone: 301-402-6641 foxb@mail.nih.gov
Referral Contact(s):
Pediatric Oncology  Phone: 1-877-624-4878 (Toll free)

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Primary Eligibility:

• 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
• 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
• Age ≤ 21 years of age
• 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: 123 I-MIBG positive at a minimum of 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)
• Recovered from all prior therapy ≤ grade 1
• No prior ABT-751
• ≥ 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)
• ≥ 30 days since last dose of investigational drug or immunotherapy
• No concurrent anti-cancer agents, radiation therapy (including palliative radiation therapy) or treatment for graft-vs-host disease
• No concurrent epoetin alfa, sargramostim (GM-CSF) or interleukin-11
• Karnofsky performance status (PS) 50–100% (> 16 years of age) OR Lansky PS 50–100% (≤ 16 years of age)
• Hemoglobin ≥ 7.5 g/dL (transfusions allowed), absolute neutrophil count > 250/uL and platelet count > 25,000/uL (without platelet transfusion support for ≥ 7 days)
• Bilirubin ≤ 1.5 x upper limit of normal (ULN), ALT < 5 x ULN
• Creatinine normal for age and gender OR creatinine clearance or radioisotope glomerular filtration rate ≥ 60 mL/min
• Cardiac function: Shortening fraction ≥ 27% by echocardiogram
• Patients with seizures eligible if on anticonvulsants and are well controlled; neurologic toxicity from prior therapy or tumor involvement must be ≤ Grade 2
• No evidence of active graft-vs-host disease, no allergy to sulfa-containing medications, no known HIV positivity

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Study Outline:

This is a multicenter, historical control study. Patients are stratified according to disease type (measurable lesions by CT scan or MRI vs evaluable disease [bone marrow or iodine I 123 metaiodobenzylguanidine-positive lesions]).

• Patients receive oral ABT-751 once daily on Days 1–7
• The treatment cycle is 21 days
• Up to 52 cycles in the absence of disease progression or unacceptable toxicity
• Blood is collected periodically during course 1 for pharmacokinetic studies for those patients who receive suspension and agree to PKs
• Quality of life is assessed at baseline and prior to each course of treatment

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 6/8/09
Updated: 11/26/08