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

Not Recruiting

Trial ID: NCT00436852


This phase II trial is studying how well ABT-751 works in treating children with neuroblastoma that has relapsed or not responded to previous treatment. Drugs used in chemotherapy, such as ABT-751, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Official Title

A Phase II Study of ABT-751, an Orally Bioavailable Tubulin Binding Agent, in Children With Relapsed or Refractory Neuroblastoma

Stanford Investigator(s)


Inclusion Criteria:

   - Histologically or cytologically confirmed neuroblastoma meeting the following

      - 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

      - 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

   - 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

   - 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


drug: ABT-751

procedure: quality-of-life assessment

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Neyssa Marina

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