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| Sponsor: | University of Chicago |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00058019 |
Purpose
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: | 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 |
| Estimated Enrollment: | 76 |
| Study Start Date: | February 2003 |
| Primary Completion Date: | August 2010 (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.
Eligibility| 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
Contacts and Locations| United States, Illinois | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| Louis A. Weiss Memorial Hospital | |
| Chicago, Illinois, United States, 60640 | |
| Decatur Memorial Hospital Cancer Care Institute | |
| Decatur, Illinois, United States, 62526 | |
| Evanston Hospital | |
| Evanston, Illinois, United States, 60201-1781 | |
| Ingalls Cancer Care Center at Ingalls Memorial Hospital | |
| Harvey, Illinois, United States, 60426 | |
| La Grange Memorial Hospital | |
| La Grange, Illinois, United States, 60525 | |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153 | |
| Oncology Hematology Associates of Central Illinois, PC - Peoria | |
| Peoria, Illinois, United States, 61615-7828 | |
| Central Illinois Hematology Oncology Center | |
| Springfield, Illinois, United States, 62701 | |
| United States, Indiana | |
| Fort Wayne Medical Oncology and Hematology | |
| Fort Wayne, Indiana, United States, 46885-5099 | |
| CCOP - Northern Indiana CR Consortium | |
| South Bend, Indiana, United States, 46601 | |
| United States, Michigan | |
| Oncology Care Associates, PLLC | |
| Saint Joseph, Michigan, United States, 49085 | |
| United States, Wisconsin | |
| Medical College of Wisconsin Cancer Center | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Study Chair: | Sonali M. Smith, MD | University of Chicago |
More Information
| Responsible Party: | Charles Erlichman, Mayo Clinic Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00058019 History of Changes |
| Other Study ID Numbers: | CDR0000285683, UCCRC-11965B, NCI-5913, UCCRC-NCI-5913 |
| Study First Received: | April 7, 2003 |
| Last Updated: | September 1, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
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 |
|
Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |