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CompletedNCT00052572Updated Jun 24, 2013

Ixabepilone in Treating Patients With Relapsed or Refractory Lymphoproliferative Disorders

A Phase 2 interventional study of ixabepilone in Leukemia and Lymphoma, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-06-24.

Sponsored by Memorial Sloan Kettering Cancer Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
35
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 35 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.

Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)
Enrollment
35 participants (estimated)

Interventions

  • Drugixabepilone
06

What researchers measure

Primary outcomes

  1. Safety

  2. Efficacy

Secondary outcomes

  1. Progression-free survival

  2. Mean and median duration of response

  3. Mean and median duration of progression-free and overall survival

  4. Probability of polymerase chain reaction negativity after treatment

07

Study locations

2 sites
  • Memorial Sloan-Kettering Cancer Center
    New York, New York 10021, United States
  • Vermont Cancer Center at University of Vermont
    Burlington, Vermont 05401-3498, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00052572
Lead sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
First posted
Jan 27, 2003
Start date
Oct 2002
Completion
Jul 2007
Last update
Jun 24, 2013

Study contacts

Owen A. O'Connor, MD, PhD
study chair · Memorial Sloan Kettering Cancer Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2006. You cannot join it, but the record below documents what was studied.

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