Ixabepilone in Treating Patients With Relapsed or Refractory Lymphoproliferative Disorders

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00052572
First received: January 24, 2003
Last updated: June 21, 2013
Last verified: April 2006
  Purpose

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: 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 [ Designated as safety issue: Yes ]
  • Efficacy [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]
  • Mean and median duration of response [ Designated as safety issue: No ]
  • Mean and median duration of progression-free and overall survival [ Designated as safety issue: No ]
  • Probability of polymerase chain reaction negativity after treatment [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00052572

Locations
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
Investigators
Study Chair: Owen A. O'Connor, MD, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00052572     History of Changes
Other Study ID Numbers: CDR0000258542, MSKCC-02046, NCI-5342
Study First Received: January 24, 2003
Last Updated: June 21, 2013
Health Authority: United States: Federal Government

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:
Leukemia
Lymphoma
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Neoplasms
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 16, 2014