ABT-751 in Treating Children With Neuroblastoma That Has Relapsed or Not Responded to Previous Treatment
Condition: Disseminated Neuroblastoma; Recurrent Neuroblastoma
MeSH terms: Neuroblastoma
Intervention: ABT-751; quality-of-life assessment
Intervention description: Given orally; Ancillary studies
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 92.0
Sex: All
Maximum age: 21 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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