Ixabepilone in Treating Patients With Relapsed or Refractory Lymphoproliferative Disorders

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00052572

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Duration (Months)

17.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia Lymphoma	Drug: ixabepilone	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

35 participants

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Multicenter Phase II Study Of BMS 247550 (Epothilone B Analogue) In Indolent Lymphoproliferative Disorders

Study Start Date :

Oct 1, 2002

Actual Study Completion Date :

Jul 1, 2007

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021
2	Vermont Cancer Center at University of Vermont	Burlington	Vermont	United States	05401-3498