Spots Global Cancer Trial Database for ABT-751 in Treating Children With Neuroblastoma That Has Relapsed or Not Responded to Previous Treatment
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Trial Identification
Brief Title: ABT-751 in Treating Children With Neuroblastoma That Has Relapsed or Not Responded to Previous Treatment
Official Title: A Phase II Study of ABT-751, an Orally Bioavailable Tubulin Binding Agent, in Children With Relapsed or Refractory Neuroblastoma
Study ID: NCT00436852
Study Description
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, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
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 the objective response rate in patients with measurable disease treatment with this drug. II. Determine whether ABT-751 improves quality of life of these patients. III. Determine the toxicity of ABT-751. IV. Determine the pharmacokinetic profile of ABT-751 in these patients. OUTLINE: 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. After completion of study treatment, patients are followed up for up to 5.1 years.
Keywords
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
C S Mott Children's Hospital, Ann Arbor, Michigan, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Columbia University Medical Center, New York, New York, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Nationwide Children's Hospital, Columbus, Ohio, United States
Oregon Health and Science University, Portland, Oregon, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Cook Children's Medical Center, Fort Worth, Texas, United States
Hospital for Sick Children, Toronto, Ontario, Canada
Contact Details
Name: Elizabeth Fox, MD
Affiliation: Children's Oncology Group
Role: PRINCIPAL_INVESTIGATOR
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