Ixabepilone in Treating Patients With Relapsed or Refractory Lymphoproliferative Disorders
Leukemia, Lymphoma
About this trial
This is an interventional treatment trial for Leukemia focused on measuring refractory chronic lymphocytic leukemia, B-cell chronic lymphocytic leukemia, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, Waldenström 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
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed relapsed/recurrent or refractory indolent lymphoproliferative disorder of 1 of the following types: Chronic lymphocytic leukemia Absolute lymphocytosis greater than 5,000/mm^3 B-cell phenotype (CD 19, 20, or 23 positive) with more than 30% bone marrow lymphocytes 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 At least 2 cm by conventional techniques No active brain metastases Treated CNS disease allowed PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 60-100% Life expectancy At least 3 months Hematopoietic Absolute neutrophil count ≥ 1,000/mm^3 (500/mm^3 if there is lymphomatous involvement of the bone marrow) Platelet count ≥ 50,000/mm^3 Hepatic Bilirubin ≤ 1.5 times upper limit of normal (ULN) AST or ALT ≤ 2.5 times ULN (4 times ULN if there is liver involvement) Renal Creatinine ≤ 2 times ULN OR Creatinine clearance ≥ 50 mL/min 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 Bifascicular block 2^nd- or 3^rd-degree atrioventricular block Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No other immunodeficiency No known severe hypersensitivity reaction to agents containing Cremophor EL No ongoing or active infection Febrile episodes up to 38.5° Celsius allowed in the absence of infection No other concurrent uncontrolled illness that would preclude study participation No psychiatric illness or social situation that would preclude study compliance No preexisting grade II or greater sensory neuropathy PRIOR CONCURRENT THERAPY: Biologic therapy At least 3 months since prior monoclonal antibodies (unless there is clearly documented evidence of disease progression after therapy) At least 3 months since prior radioimmunotherapy No prior allogeneic bone marrow transplantation 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) Cytoreduction plus HDC is considered 1 chemotherapy regimen No other concurrent chemotherapy Endocrine therapy At least 7 days since prior steroids Radiotherapy More than 3 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery More than 4 weeks since prior major surgery Other Use of antibiotics for marginal zone lymphoma does not count as a prior therapy No other concurrent investigational agents No other concurrent anticancer therapy
Sites / Locations
- Memorial Sloan-Kettering Cancer Center
- Vermont Cancer Center at University of Vermont