Expired Study
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Burlington, Vermont 05401


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

CDR0000258542


NCT ID:

NCT00052572


Secondary ID:

MSKCC-02046


Study Acronym:


Brief Title:

Ixabepilone in Treating Patients With Relapsed or Refractory Lymphoproliferative Disorders


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Masking: Open Label, Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

35


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Owen A. O'Connor, MD, PhD
Study Chair
Memorial Sloan-Kettering Cancer Center

Study Dates

Start Date:October 2002
Completion Date:July 2007
Completion Type:Actual
Verification Date:April 2006
Last Changed Date:June 21, 2013
First Received Date:January 24, 2003

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Probability of polymerase chain reaction negativity after treatment
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Mean and median duration of progression-free and overall survival
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Mean and median duration of response
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Progression-free survival
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Efficacy
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Safety
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:ixabepilone

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Memorial Sloan-Kettering Cancer Center
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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