ixabepilone in treating patients with relapsed or refractory lymphoproliferative disorders

Conditions: Leukemia; Lymphoma

Summary: 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 * determine the frequency and duration of complete and partial response rates for patients with relapsed or refractory indolent lymphoproliferative disorders treated with ixabepilone. secondary * determine the time to progression and overall survival of patients treated with this drug. * determine the toxicity of this drug in these patients. 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 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

Keywords: 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