Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00436852
Status:
COMPLETED
Last Update Posted:
2019-07-17
First Post:
2007-02-15
Brief Title:
ABT-751 in Treating Children With Neuroblastoma That Has Relapsed or Not Responded to Previous Treatment
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Phase II Study of ABT-751 an Orally Bioavailable Tubulin Binding Agent in Children With Relapsed or Refractory Neuroblastoma
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 51 years
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 51 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| COG-ANBL0621 | OTHER | Childrens Oncology Group | httpsreporternihgovquickSearchU10CA098543 |
| NCI-2009-00402 | REGISTRY | None | None |
| NCI-07-C-0074 | None | None | None |
| CDR0000529858 | OTHER | None | None |
| NCI-P6554 | None | None | None |
| U10CA098543 | NIH | None | None |