ABT-751 in Treating Children With Neuroblastoma That Has Relapsed or Not Responded to Previous Treatment - NCT00436852-53226 (Clinical Trial 162982)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy162982.aspx
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| City: |
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Milwaukee |
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State:
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WI |
| Zip Code: |
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53226 |
| Conditions: |
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Neuroblastoma |
| Purpose: |
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RATIONALE: 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.
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.
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| Study summary: |
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OBJECTIVES:
Primary
- Compare the time to disease progression in children with refractory or relapsed
neuroblastoma treated with ABT-751 vs historical controls.
Secondary
- Determine the objective response rate in patients with measurable disease treatment
with this drug.
- Determine whether ABT-751 improves quality of life of these patients.
- Determine the toxicity of ABT-751.
- Determine the pharmacokinetic profile of ABT-751 in these patients.
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. Treatment repeats every 21 days for 52
courses in the absence of disease progression or unacceptable toxicity.
Blood is collected periodically during course 1 for pharmacokinetic studies.
Quality of life is assessed at baseline and prior to each course of treatment.
PROJECTED ACCRUAL: A total of 88 patients will be accrued for this study. |
| Criteria: |
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DISEASE CHARACTERISTICS:
- 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)
PATIENT CHARACTERISTICS:
- 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:
- 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])
- OR creatinine clearance or radioisotope glomerular filtration rate ≥ 60 mL/min
- 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
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- 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
- Concurrent filgrastim (G-CSF) allowed if medically indicated |
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| Study is available at: |
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Midwest Children's Cancer Center at Children's Hospital of Wisconsin
Milwaukee, WI 53226
United States
Primary Contact:
Michael E. Kelly
Phone: 414-456-4170 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 15, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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