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Home > "B" Clinical Trials Conditions > BMS-247550 in Treating Patients With Relapsed or Refractory Low-Grade Lymphoproliferative Disorders  BMS-247550 in Treating Patients With Relapsed or Refractory Low-Grade Lymphoproliferative Disorders
BMS-247550 in Treating Patients With Relapsed or Refractory Low-Grade Lymphoproliferative Disorders
For Condition: Waldenstrom's Macroglobulinemia,Chronic Lymphocytic Leukemia,adult non-Hodgkin's lymphoma
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: 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 BMS-247550 in treating patients who have relapsed or refractorylow-gradelymphoproliferative disorders.
Details: OBJECTIVES: - Determine the frequency and duration of complete and partial response rates for patients with relapsed or refractory low-grade lymphoproliferative disorders treated with BMS-247550. - Determine the pharmacodynamics of this drug in these patients. - Determine the time to progression and overall survival of patients treated with this drug. - Determine the toxicity of this drug in these patients. - Determine the influence of prior response duration on response rates of patients treated with this drug. OUTLINE: This is a multicenter study. Patients are stratified according to response to prior therapy (at least partial response lasting less than 6 months or refractory disease after no more than 3 prior cytotoxic regimens vs at least partial response lasting at least 6 months after last therapy with no limit on prior therapies). Patients receive BMS-247550 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 26-79 patients (12-35 for stratum I, 14-44 for stratum II) will be accrued for this study within 1-1.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed relapsed/recurrent or refractory low-grade 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 - Extranodal marginal zone B-cell lymphoma - Grade I-III follicle center cell lymphoma - Nodal marginal zone B-cell lymphoma - Waldenstrom's macroglobulinemia - 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 NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 60-100% Life expectancy - At least 3 months Hematopoietic - See Disease Characteristics - Absolute neutrophil count greater than 2,000/mm^3 (500/mm^3 if lymphomatous involvement of the bone marrow) - Platelet count at least 100,000/mm^3 (50,000/mm^3 if lymphomatous involvement of the bone marrow or splenomegaly) Hepatic - Bilirubin less than 1.5 times upper limit of normal (ULN) - AST/ALT no greater than 2.5 times ULN (4 times ULN if liver involvement) Renal - Creatinine less than 2 times ULN Cardiovascular - No history of orthostatic hypotension - No myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 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 echocardiogram evidence of any of the following: - 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 prior 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 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
OwenO'Connor, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Andrew Zelenetz 212-639-2656
Additional Information:
Study ID Numbers: CDR0000258542; NCI-5342,MSKCC-02046
Study Start Date:
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00052572
Other Chronic Lymphocytic Leukemia Studies:
1. Monoclonal Antibody Therapy and Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma
2. Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Waldenstrom's Macroglobulinemia
3. Bortezomib in Treating Patients With Waldenstrom's Macroglobulinemia
4. 506U78 in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma or T-cell Lymphoma
5. Radiolabeled Monoclonal Antibody Therapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Lymphoma or Waldenstrom's Macroglobulinemia
Related Studies:
Other Chronic Lymphocytic Leukemia Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
BMS-247550 in Treating Patients With Relapsed or Refractory Low-Grade Lymphoproliferative Disorders
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