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Ixabepilone in Treating Patients With Relapsed or Refractory Lymphoproliferative Disorders

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: January 24, 2003
Last updated: June 21, 2013
Last verified: April 2006

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 Intervention Phase
Leukemia Lymphoma Drug: ixabepilone Phase 2

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Phase II Study Of BMS 247550 (Epothilone B Analogue) In Indolent Lymphoproliferative Disorders

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

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

Estimated Enrollment: 35
Study Start Date: October 2002
Study Completion Date: July 2007
Detailed Description:



  • 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.


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


  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Owen A. O'Connor, MD, PhD Memorial Sloan Kettering Cancer Center
  More Information Identifier: NCT00052572     History of Changes
Other Study ID Numbers: CDR0000258542
Study First Received: January 24, 2003
Last Updated: June 21, 2013

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases processed this record on September 21, 2017