Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Children's Oncology Group

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Drug: ABT-751
  • Procedure: quality-of-life assessment

Phase:

Phase 2

Eligibility


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

Ages Eligible for Study

N/A - 21 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Neyssa Marina
6507235535
Not Recruiting