Ixabepilone in Treating Patients With Relapsed or Refractory Lymphoproliferative Disorders
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00052572 |
Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : June 24, 2013
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Leukemia Lymphoma | Drug: ixabepilone | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 35 participants |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multicenter Phase II Study Of BMS 247550 (Epothilone B Analogue) In Indolent Lymphoproliferative Disorders |
Study Start Date : | October 2002 |
Actual Study Completion Date : | July 2007 |

- Safety
- Efficacy
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00052572
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 | |
United States, Vermont | |
Vermont Cancer Center at University of Vermont | |
Burlington, Vermont, United States, 05401-3498 |
Study Chair: | Owen A. O'Connor, MD, PhD | Memorial Sloan Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00052572 |
Other Study ID Numbers: |
CDR0000258542 MSKCC-02046 NCI-5342 |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | June 24, 2013 |
Last Verified: | April 2006 |
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 |
Lymphoma Leukemia Lymphoproliferative Disorders Neoplasms by Histologic Type |
Neoplasms Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |