Status:
COMPLETED
ABT-751 in Treating Children With Neuroblastoma That Has Relapsed or Not Responded to Previous Treatment
Lead Sponsor:
Children's Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Disseminated Neuroblastoma
Recurrent Neuroblastoma
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE2
Brief 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, wo...
Detailed Description
PRIMARY OBJECTIVES: I. Compare the time to disease progression in children with refractory or relapsed neuroblastoma treated with ABT-751 vs historical controls. SECONDARY OBJECTIVES: I. Determine ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2015
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00436852
Start Date
January 1 2007
End Date
March 30 2015
Last Update
July 17 2019
Active Locations (12)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637-1470
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
4
C S Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109