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Ixabepilone in Treating Patients With Relapsed or Refractory Lymphoproliferative Disorders

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00052572
Enrollment
35
Registered
2003-01-27
Start date
2002-10-31
Completion date
2007-07-31
Last updated
2013-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGixabepilone

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Safety
Efficacy

Secondary

MeasureTime frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026