Ixabepilone in Treating Patients With Relapsed or Refractory Lymphoproliferative Disorders
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma |
Drug: ixabepilone |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multicenter Phase II Study Of BMS 247550 (Epothilone B Analogue) In Indolent Lymphoproliferative Disorders |
- Safety [ Designated as safety issue: Yes ]
- Efficacy [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Mean and median duration of response [ Designated as safety issue: No ]
- Mean and median duration of progression-free and overall survival [ Designated as safety issue: No ]
- Probability of polymerase chain reaction negativity after treatment [ Designated as safety issue: No ]
| Estimated Enrollment: | 35 |
| Study Start Date: | October 2002 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| United States, Vermont | |
| Vermont Cancer Center at University of Vermont | |
| Burlington, Vermont, United States, 05401-3498 | |
| Study Chair: | Owen A. O'Connor, MD, PhD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00052572 History of Changes |
| Other Study ID Numbers: | CDR0000258542, MSKCC-02046, NCI-5342 |
| Study First Received: | January 24, 2003 |
| Last Updated: | February 19, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Leukemia Lymphoma Lymphoproliferative Disorders Neoplasms by Histologic Type |
Neoplasms Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on June 17, 2013