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Sponsors and Collaborators: |
University of Chicago National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00058019 |
RATIONALE: Drugs used in chemotherapy, such as BMS-247550, work in different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well BMS-247550 works in treating patients with relapsed or refractory aggressive non-Hodgkin's lymphoma.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: ixabepilone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study Of Epothilone B Analog BMS-247550 (NSC 710428) In Patients With Relapsed Aggressive Non-Hodgkin's Lymphomas |
Estimated Enrollment: | 76 |
Study Start Date: | February 2003 |
Estimated Primary Completion Date: | May 2004 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive BMS-247550 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.
PROJECTED ACCRUAL: A total of 37-76 patients (22-46 for cohort 1 and 15-30 for cohort 2) will be accrued for this study within 12-18 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed aggressive non-Hodgkin's lymphoma of 1 of the following cellular types:
Anaplastic large cell of 1 of the following subtypes:
Relapsed or refractory disease after prior standard chemotherapy, meeting criteria for 1 of the following cohorts:
Cohort 2 (refractory): Stable disease or less than a PR after the most recent prior therapy
Measurable disease
Ineligible for or unwilling to undergo hematopoietic stem cell transplantation
No known CNS involvement by lymphoma
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Illinois | |
Cardinal Bernardin Cancer Center at Loyola University Medical Center | Recruiting |
Maywood, Illinois, United States, 60153 | |
Contact: Clinical Trials Office - Cardinal Bernardin Cancer Center 708-226-4357 | |
Central Illinois Hematology Oncology Center | Recruiting |
Springfield, Illinois, United States, 62701 | |
Contact: Edem S. Agamah, MD, MS 217-525-2500 ihdn@aol.com | |
Decatur Memorial Hospital Cancer Care Institute | Recruiting |
Decatur, Illinois, United States, 62526 | |
Contact: Clinical Trials Office - Decatur Memorial Hospital Cancer Care 217-876-6601 | |
La Grange Memorial Hospital | Recruiting |
La Grange, Illinois, United States, 60525 | |
Contact: Clinical Trials Office - La Grange Memorial Hospital 630-856-7526 | |
Ingalls Cancer Care Center at Ingalls Memorial Hospital | Recruiting |
Harvey, Illinois, United States, 60426 | |
Contact: Clinical Trials Office - Ingalls Cancer Care Center at Ingalls 708-915-6747 | |
Evanston Northwestern Healthcare - Evanston Hospital | Recruiting |
Evanston, Illinois, United States, 60201-1781 | |
Contact: Clinical Trials Office - Evanston Northwestern Healthcare - Ev 847-570-1381 | |
Louis A. Weiss Memorial Hospital | Recruiting |
Chicago, Illinois, United States, 60640 | |
Contact: Clinical Trials Office - Louis A. Weiss Memorial Hospital 773-564-5044 | |
Oncology Hematology Associates of Central Illinois, PC - Peoria | Recruiting |
Peoria, Illinois, United States, 61615-7828 | |
Contact: James A. Knost, MD, FACP 309-243-3000 | |
University of Chicago Cancer Research Center | Recruiting |
Chicago, Illinois, United States, 60637-1470 | |
Contact: Clinical Trials Office - University of Chicago Cancer Research 773-834-7424 | |
United States, Indiana | |
CCOP - Northern Indiana CR Consortium | Recruiting |
South Bend, Indiana, United States, 46601 | |
Contact: David A. Taber, MD 574-647-3353 | |
Fort Wayne Medical Oncology and Hematology | Recruiting |
Fort Wayne, Indiana, United States, 46885-5099 | |
Contact: David F. Sciortino, MD 260-484-8830 | |
United States, Michigan | |
Oncology Care Associates, PLLC | Recruiting |
Saint Joseph, Michigan, United States, 49085 | |
Contact: Eric P. Lester, MD 269-985-0029 | |
United States, Wisconsin | |
Medical College of Wisconsin Cancer Center | Recruiting |
Milwaukee, Wisconsin, United States, 53226 | |
Contact: Clinical Trials Office - Medical College of Wisconsin Cancer C 414-805-4380 |
Study Chair: | Sonali M. Smith, MD | University of Chicago |
Study ID Numbers: | CDR0000285683, UCCRC-11965B, NCI-5913, UCCRC-NCI-5913 |
Study First Received: | April 7, 2003 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00058019 |
Health Authority: | Unspecified |
recurrent grade 3 follicular lymphoma recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma |
recurrent adult Burkitt lymphoma recurrent mantle cell lymphoma anaplastic large cell lymphoma |
Epothilone B Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Epothilones Lymphoma, Mantle-Cell Lymphoma, Follicular Lymphoma, small cleaved-cell, diffuse Mantle cell lymphoma Recurrence Lymphoma, large-cell |
Burkitt's lymphoma Lymphatic Diseases Burkitt Lymphoma Lymphoma, Large-Cell, Anaplastic Anaplastic large cell lymphoma Lymphoma, Non-Hodgkin Aggression Lymphoproliferative Disorders Lymphoma Follicular lymphoma |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |