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| Tracking Information | |||||
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| First Received Date ICMJE | April 7, 2003 | ||||
| Last Updated Date | June 3, 2009 | ||||
| Start Date ICMJE | February 2003 | ||||
| Estimated Primary Completion Date | May 2004 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00058019 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||
| Brief Title ICMJE | BMS-247550 in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma | ||||
| Official Title ICMJE | A Phase II Study Of Epothilone B Analog BMS-247550 (NSC 710428) In Patients With Relapsed Aggressive Non-Hodgkin's Lymphomas | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Open Label | ||||
| Condition ICMJE | Lymphoma | ||||
| Intervention ICMJE | Drug: ixabepilone | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 76 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | May 2004 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | |||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00058019 | ||||
| Responsible Party | Charles Erlichman, Mayo Clinic Cancer Center | ||||
| Study ID Numbers ICMJE | CDR0000285683, UCCRC-11965B, NCI-5913, UCCRC-NCI-5913 | ||||
| Study Sponsor ICMJE | University of Chicago | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | October 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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