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| ID | Type | Description | Link |
|---|---|---|---|
| MSKCC-02046 | |||
| NCI-5342 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ixabepilone | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | ||
| Efficacy |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | ||
| Mean and median duration of response | ||
| Mean and median duration of progression-free and overall survival |
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DISEASE CHARACTERISTICS:
Histologically confirmed relapsed/recurrent or refractory indolent lymphoproliferative disorder of 1 of the following types:
Chronic lymphocytic leukemia
B-cell small lymphocytic lymphoma
Marginal zone B-cell lymphoma
Grade I-III follicle center cell lymphoma
Waldenstrom's macroglobulinemia
Mantle cell lymphoma
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 history of orthostatic hypotension
No myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 3 months
No New York Heart Association class III or IV congestive heart failure
No unstable angina pectoris
No cardiac arrhythmia
No uncontrolled hypertension requiring manipulation of antihypertensive medications
No evidence of any of the following by echocardiogram:
Acute ischemia
Significant conduction abnormality
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
At least 4 weeks since prior cytotoxic chemotherapy (6 weeks for mitomycin, nitrosoureas, or carmustine) and recovered
No more than 4 prior chemotherapy regimens (including high-dose chemotherapy [HDC] for patients with relapsed disease > 100 days after completion of HDC)
No other concurrent chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Owen A. O'Connor, MD, PhD | Memorial Sloan Kettering Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | United States | ||
| Vermont Cancer Center at University of Vermont |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D008224 | Lymphoma, Follicular |
| D008258 | Waldenstrom Macroglobulinemia |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D020522 | Lymphoma, Mantle-Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C430592 | ixabepilone |
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| Probability of polymerase chain reaction negativity after treatment |
| Burlington |
| Vermont |
| 05401-3498 |
| United States |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008228 | Lymphoma, Non-Hodgkin |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D016393 | Lymphoma, B-Cell |