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

Not Recruiting

Trial ID: NCT00436852

Purpose

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)

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

Intervention(s):

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
6507235535

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