Ixabepilone in Treating Patients With Relapsed or Refractory Lymphoproliferative Disorders

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. Identifier: NCT00052572
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 24, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

January 24, 2003
January 27, 2003
June 24, 2013
October 2002
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  • Safety
  • Efficacy
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Complete list of historical versions of study NCT00052572 on Archive Site
  • 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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Ixabepilone in Treating Patients With Relapsed or Refractory Lymphoproliferative Disorders
A Multicenter Phase II Study Of BMS 247550 (Epothilone B Analogue) In Indolent Lymphoproliferative Disorders

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.



  • Determine the frequency and duration of complete and partial response rates for patients with relapsed or refractory indolent lymphoproliferative disorders treated with ixabepilone.


  • 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.

Phase 2
Masking: None (Open Label)
Primary Purpose: Treatment
  • Leukemia
  • Lymphoma
Drug: ixabepilone
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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July 2007
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  • 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



  • 18 and over

Performance status

  • Karnofsky 60-100%

Life expectancy

  • At least 3 months


  • 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


  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST or ALT ≤ 2.5 times ULN (4 times ULN if there is liver involvement)


  • Creatinine ≤ 2 times ULN OR
  • Creatinine clearance ≥ 50 mL/min


  • 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


  • 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


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


  • 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


  • More than 3 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy


  • More than 4 weeks since prior major surgery


  • Use of antibiotics for marginal zone lymphoma does not count as a prior therapy
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Owen A. O'Connor, MD, PhD Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
April 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP