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


Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia, Lymphoma

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety

Safety Issue:

Yes

Principal Investigator

Owen A. O'Connor, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000258542

NCT ID:

NCT00052572

Start Date:

October 2002

Completion Date:

July 2007

Related Keywords:

  • Leukemia
  • Lymphoma
  • refractory chronic lymphocytic leukemia
  • B-cell chronic lymphocytic leukemia
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • Waldenström macroglobulinemia
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • recurrent mantle cell lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • Leukemia
  • Lymphoma
  • Lymphoproliferative Disorders

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Vermont Cancer Center at University of VermontBurlington, Vermont  05405-0075