Ixabepilone in Treating Patients With Relapsed or Refractory Lymphoproliferative Disorders

Study Overview
=================
Brief 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.

Detailed Description
-----------------
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.

Official Title
-----------------
A Multicenter Phase II Study Of BMS 247550 (Epothilone B Analogue) In Indolent Lymphoproliferative Disorders

Conditions
-----------------
Lymphoma, Leukemia

Intervention / Treatment
-----------------
* Drug: ixabepilone


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ixabepilone|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  |  | 
| Efficacy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  |  | 
| Mean and median duration of response |  |  | 
| Mean and median duration of progression-free and overall survival |  |  | 
| Probability of polymerase chain reaction negativity after treatment |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
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