AzTrials
AzTrials

LeukemiaPhase 2NCT00052572

Ixabepilone in Treating Patients With Relapsed or Refractory Lymphoproliferative Disorders

A Phase 2 study testing ixabepilone in people with Leukemia and Lymphoma, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leukemia, Lymphoma
What is being tested?
ixabepilone
How many people
35 participants
Where
2 sitesUnited States
Study dates
Oct 2002to Jul 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Vermont Cancer Center at University of Vermont

    Burlington, Vermont, 05401-3498

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

Other trials in United States

About this study

Official title: 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.

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.

Conditions
Leukemia, Lymphoma
Being tested
ixabepilone
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
Medical subject headings
Leukemia, Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Follicular, Waldenstrom Macroglobulinemia, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Mantle-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ixabepiloneDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety

  2. Efficacy

Secondary outcomes (4)
  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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startOct 2002
  3. Study completionJul 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00052572
Sponsor's protocol ID
CDR0000258542
Other IDs
MSKCC-02046, NCI-5342
Status last verified
Apr 2006
First submitted
24 Jan 2003
Last updated
24 Jun 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ixabepilone in people with Leukemia and Lymphoma, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2013.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in