Ixabepilone in Treating Patients With Relapsed or Refractory Lymphoproliferative Disorders

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00052572
• Other study ID #: CDR0000258542
• Secondary ID: MSKCC-02046NCI-5
• Status: Completed
• Phase: Phase 2
• First received: January 24, 2003
• Last updated: June 21, 2013
• Start date: October 2002
• Est. completion date: July 2007

Study information

• Verified date: April 2006
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Lymphoma
• Lymphoproliferative Disorders

Intervention

Drug:
• ixabepilone

Locations

Country	Name	City	State
United States	Vermont Cancer Center at University of Vermont	Burlington	Vermont
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety			Yes
Primary	Efficacy			No
Secondary	Progression-free survival			No
Secondary	Mean and median duration of response			No
Secondary	Mean and median duration of progression-free and overall survival			No
Secondary	Probability of polymerase chain reaction negativity after treatment			No