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Ixabepilone in Treating Patients With Relapsed or Refractory Lymphoproliferative Disorders

Primary Purpose

Leukemia, Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ixabepilone
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Outcomes

Primary Outcome Measures

Safety
Efficacy

Secondary Outcome Measures

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

Full Information

First Posted
January 24, 2003
Last Updated
June 21, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00052572
Brief Title
Ixabepilone in Treating Patients With Relapsed or Refractory Lymphoproliferative Disorders
Official Title
A Multicenter Phase II Study Of BMS 247550 (Epothilone B Analogue) In Indolent Lymphoproliferative Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
April 2006
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphoma
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ixabepilone
Primary Outcome Measure Information:
Title
Safety
Title
Efficacy
Secondary Outcome Measure Information:
Title
Progression-free survival
Title
Mean and median duration of response
Title
Mean and median duration of progression-free and overall survival
Title
Probability of polymerase chain reaction negativity after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Owen A. O'Connor, MD, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Vermont Cancer Center at University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401-3498
Country
United States

12. IPD Sharing Statement

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Ixabepilone in Treating Patients With Relapsed or Refractory Lymphoproliferative Disorders

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