Ixabepilone in Treating Patients With Relapsed or Refractory Lymphoproliferative Disorders
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|ClinicalTrials.gov Identifier: NCT00052572|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 24, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Lymphoma||Drug: ixabepilone||Phase 2|
- Determine the frequency and duration of complete and partial response rates for patients with relapsed or refractory indolent lymphoproliferative disorders treated with ixabepilone.
- 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 1-1.5 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Phase II Study Of BMS 247550 (Epothilone B Analogue) In Indolent Lymphoproliferative Disorders|
|Study Start Date :||October 2002|
|Actual Study Completion Date :||July 2007|
- Progression-free survival
- Mean and median duration of response
- Mean and median duration of progression-free and overall survival
- Probability of polymerase chain reaction negativity after treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00052572
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|United States, Vermont|
|Vermont Cancer Center at University of Vermont|
|Burlington, Vermont, United States, 05401-3498|
|Study Chair:||Owen A. O'Connor, MD, PhD||Memorial Sloan Kettering Cancer Center|