ABT-751 in Treating Children With Neuroblastoma That Has Relapsed or Not Responded to Previous Treatment
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.
Other: pharmacological study
Procedure: quality-of-life assessment
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Study of ABT-751, an Orally Bioavailable Tubulin Binding Agent, in Children With Recurrent or Refractory Neuroblastoma|
- Time to progression [ Designated as safety issue: No ]
- Response [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Quality of life [ Designated as safety issue: No ]
|Study Start Date:||January 2007|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
- Compare the time to disease progression in children with refractory or relapsed neuroblastoma treated with ABT-751 vs historical controls.
- 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.
Show 34 Study Locations
|Study Chair:||Elizabeth Fox, MD||National Cancer Institute (NCI)|
|Investigator:||Yael P. Mosse, MD||Children's Hospital of Philadelphia|