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| Sponsor: | Memorial Sloan-Kettering Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00052572 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma |
Drug: ixabepilone |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Multicenter Phase II Study Of BMS 247550 (Epothilone B Analogue) In Indolent Lymphoproliferative Disorders |
| Estimated Enrollment: | 35 |
| Study Start Date: | October 2002 |
OBJECTIVES:
Primary
Secondary
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed relapsed/recurrent or refractory indolent lymphoproliferative disorder of 1 of the following types:
Chronic lymphocytic leukemia
At least 1 unidimensionally measurable lesion for patients with non-Hodgkin's lymphoma
No active brain metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
No evidence of any of the following by echocardiogram:
Significant conduction abnormality
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
No more than 4 prior chemotherapy regimens (including high-dose chemotherapy [HDC] for patients with relapsed disease > 100 days after completion of HDC)
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | CDR0000258542, MSKCC-02046, NCI-5342 |
| Study First Received: | January 24, 2003 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00052572 History of Changes |
| Health Authority: | United States: Federal Government |
|
refractory chronic lymphocytic leukemia B-cell chronic lymphocytic leukemia recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma Waldenstrom macroglobulinemia |
recurrent marginal zone lymphoma recurrent small lymphocytic lymphoma recurrent mantle cell lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma |
|
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Epothilones Mitosis Modulators Antimitotic Agents |
Pharmacologic Actions Leukemia Lymphatic Diseases Neoplasms Therapeutic Uses Tubulin Modulators Lymphoproliferative Disorders Lymphoma |