Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00052572
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2003-01-24
Brief Title:
Ixabepilone in Treating Patients With Relapsed or Refractory Lymphoproliferative Disorders
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Multicenter Phase II Study Of BMS 247550 Epothilone B Analogue In Indolent Lymphoproliferative Disorders
Status:
COMPLETED
Status Verified Date:
2006-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of ixabepilone in treating patients who have relapsed or refractory lymphoproliferative disorders
PURPOSE Phase II trial to study the effectiveness of ixabepilone in treating patients who have relapsed or refractory lymphoproliferative disorders
Detailed Description:
OBJECTIVES
Primary
Determine the frequency and duration of complete and partial response rates for patients with relapsed or refractory indolent lymphoproliferative disorders treated with ixabepilone
Secondary
Determine the time to progression and overall survival of patients treated with this drug
Determine the toxicity of this drug in these patients
OUTLINE This is an open-label study
Patients receive ixabepilone IV over 1 hour weekly for 3 weeks Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 35 patients will be accrued for this study within 1-15 years
Primary
Determine the frequency and duration of complete and partial response rates for patients with relapsed or refractory indolent lymphoproliferative disorders treated with ixabepilone
Secondary
Determine the time to progression and overall survival of patients treated with this drug
Determine the toxicity of this drug in these patients
OUTLINE This is an open-label study
Patients receive ixabepilone IV over 1 hour weekly for 3 weeks Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 35 patients will be accrued for this study within 1-15 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 |
|---|---|---|---|
| NCI-5342 | None | None | None |
| MSKCC-02046 | None | None | None |