Ixabepilone in Treating Patients With Relapsed or Refractory Lymphoproliferative Disorders
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multicenter Phase II Study Of BMS 247550 (Epothilone B Analogue) In Indolent Lymphoproliferative Disorders|
- Safety [ Designated as safety issue: Yes ]
- Efficacy [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Mean and median duration of response [ Designated as safety issue: No ]
- Mean and median duration of progression-free and overall survival [ Designated as safety issue: No ]
- Probability of polymerase chain reaction negativity after treatment [ Designated as safety issue: No ]
|Study Start Date:||October 2002|
|Study Completion Date:||July 2007|
- 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.
|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|