Ixabepilone in Treating Patients With Relapsed or Refractory Lymphoproliferative Disorders

NCT ID: NCT00052572

Last Updated: 2013-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-10-31
• Study Completion Date: 2007-07-31

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.

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

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

ixabepilone

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Owen A. O'Connor, MD, PhD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Vermont Cancer Center at University of Vermont

Burlington, Vermont, United States

Countries

United States

Other Identifiers

MSKCC-02046

Identifier Type: -

Identifier Source: secondary_id

NCI-5342

Identifier Type: -

Identifier Source: secondary_id

CDR0000258542

Identifier Type: -

Identifier Source: org_study_id