Ixabepilone in Treating Patients With Relapsed or Refractory Lymphoproliferative Disorders

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)

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