Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Ixabepilone in Treating Patients With Relapsed or Refractory Lymphoproliferative Disorders

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	MSKCC-02046 NCI-5342, 5342, NCT00052572

Objectives

Primary

1. Determine the frequency and duration of complete and partial response rates for patients with relapsed or refractory indolent lymphoproliferative disorders treated with ixabepilone.

Secondary

1. Determine the time to progression and overall survival of patients treated with this drug.
2. Determine the toxicity of this drug in these patients.

Entry 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/mm³
    • 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• Karnofsky 60-100%

Life expectancy

• At least 3 months

Hematopoietic

• Absolute neutrophil count ≥ 1,000/mm³ (500/mm³ if there is lymphomatous involvement of the bone marrow)
• Platelet count ≥ 50,000/mm³

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

Expected Enrollment

A total of 35 patients will be accrued for this study within 1-1.5 years.

Outcomes

Safety
Efficacy

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

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.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Owen O'Connor, MD, PhD, Protocol chair(Contact information may not be current)		Ph: 212-639-8889; 800-525-2225

Registry Information
Official Title		A Multicenter Phase II Study Of BMS 247550 (Epothilone B Analogue) In Indolent Lymphoproliferative Disorders
Trial Start Date		2002-10-22
Registered in ClinicalTrials.gov		NCT00052572
Date Submitted to PDQ		2002-10-07
Information Last Verified		2006-04-01
NCI Grant/Contract Number		CA08748

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