Ixabepilone in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
This phase II trial is studying how well ixabepilone works in treating patients with relapsed or refractory aggressive non-Hodgkin's lymphoma. Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop cancer cells from dividing so they stop growing or die
Anaplastic Large Cell Lymphoma
Recurrent Adult Burkitt Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Diffuse Mixed Cell Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Mantle Cell Lymphoma
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study Of Epothilone B Analog BMS-247550 (NSC 710428) In Patients With Relapsed Aggressive Non-Hodgkin's Lymphomas|
- Objective overall response rate to intravenous administration of ixabepilone in patients with relapsed chemosensitive or refractory aggressive NHL [ Time Frame: Every 8 weeks and then 4 weeks following initial objective response ] [ Designated as safety issue: No ]Each patient will be assigned one of the following categories: 1) complete response or CRu, 2) partial response, 3) stable disease, 4) progressive disease, 5) early death from malignant disease, 6) early death from toxicity, 7) early death because of other cause, or 9) unknown (not assessable, insufficient data). The 95% confidence intervals will be provided.
- Safety and toxicity of ixabepilone [ Time Frame: Weekly and every 8 weeks after completion of study treatment ] [ Designated as safety issue: Yes ]Graded using the National Cancer Institute Common Toxicity Criteria (CTC) version 2.0.
- Duration of response [ Time Frame: 4 weeks following initial objective response and then every 8 weeks ] [ Designated as safety issue: No ]Measured from the time measurement criteria are met for CR/CRu/PR (whichever is first recorded) until the first date that PD is objectively documented.
- Overall survival [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]Defined as the time from the first day of therapy to the date of death. If the patient is lost to follow-up, survival will be censored on the last date the patient was known to be alive.
- Time to progression [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]Defined as the time from the first day of treatment until the date PD or death is first reported. Patients who die without a reported prior progression will be considered to have progressed on the day of their death. Patients who did not progress will be censored at the day of their last tumor assessment.
|Study Start Date:||February 2003|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
Experimental: Treatment (chemotherapy)
Patients receive ixabepilone 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.
I. Determine the objective overall response rate of patients with relapsed or refractory aggressive non-Hodgkin's 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.
|United States, Illinois|
|University of Chicago Comprehensive Cancer Center|
|Chicago, Illinois, United States, 60637-1470|
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Sonali Smith||University of Chicago Comprehensive Cancer Center|