Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00058019
Status:
COMPLETED
Last Update Posted:
2014-05-23
First Post:
2003-04-07
Brief Title:
Ixabepilone in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkins Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Epothilone B Analog BMS-247550 NSC 710428 in Patients With Relapsed Aggressive Non-Hodgkins Lymphomas
Status:
COMPLETED
Status Verified Date:
2011-10
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 ixabepilone works in treating patients with relapsed or refractory aggressive non-Hodgkins lymphoma Drugs used in chemotherapy such as ixabepilone work in different ways to stop cancer cells from dividing so they stop growing or die
Detailed Description:
OBJECTIVES
I Determine the objective overall response rate of patients with relapsed or refractory aggressive non-Hodgkins lymphoma treated with BMS-247550 ixabepilone
II Determine the safety and toxicity of this drug in these patients III Determine the duration of response overall survival and time to progression in patients treated with this drug
OUTLINE This is a multi-center study
Patients receive ixabepilone intravenously IV over 1 hour on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression unacceptable toxicity or if the patient becomes a candidate for stem cell transplantation
Patients are followed every 8 weeks until disease progression
I Determine the objective overall response rate of patients with relapsed or refractory aggressive non-Hodgkins lymphoma treated with BMS-247550 ixabepilone
II Determine the safety and toxicity of this drug in these patients III Determine the duration of response overall survival and time to progression in patients treated with this drug
OUTLINE This is a multi-center study
Patients receive ixabepilone intravenously IV over 1 hour on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression unacceptable toxicity or if the patient becomes a candidate for stem cell transplantation
Patients are followed every 8 weeks until disease progression
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 |
|---|---|---|---|
| N01CM62201 | NIH | CTEP | httpsreporternihgovquickSearchN01CM62201 |
| NCI-2009-00031 | REGISTRY | None | None |
| NCI-5913 | None | None | None |
| UCCRC-NCI-5913 | None | None | None |
| CDR0000285683 | None | None | None |
| UCCRC-11965B | None | None | None |
| 11965B | OTHER | None | None |
| 5913 | OTHER | None | None |
| P30CA014599 | NIH | None | None |
| N01CM62202 | NIH | None | None |