NCT00052572

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_2 leukemia

Timeline
Completed

Started Oct 2002

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

June 24, 2013

Status Verified

April 1, 2006

First QC Date

January 24, 2003

Last Update Submit

June 21, 2013

Conditions

LeukemiaLymphoma

Keywords

refractory chronic lymphocytic leukemiaB-cell chronic lymphocytic leukemiarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomaWaldenström macroglobulinemiarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomarecurrent mantle cell lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphoma

Outcome Measures

Primary Outcomes (2)

  • Safety

  • Efficacy

Secondary Outcomes (4)

  • 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

Interventions

ixabepiloneDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Vermont Cancer Center at University of Vermont

Burlington, Vermont, 05401-3498, United States

Location

MeSH Terms

Conditions

LeukemiaLymphomaLeukemia, Lymphocytic, Chronic, B-CellLymphoma, FollicularWaldenstrom MacroglobulinemiaLymphoma, B-Cell, Marginal ZoneLymphoma, Mantle-Cell

Interventions

ixabepilone

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, B-CellLeukemia, LymphoidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, Non-HodgkinNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersLymphoma, B-Cell

Study Officials

  • Owen A. O'Connor, MD, PhD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 24, 2003

First Posted

January 27, 2003

Study Start

October 1, 2002

Study Completion

July 1, 2007

Last Updated

June 24, 2013

Record last verified: 2006-04

Locations

US(2)