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Home > "B" Clinical Trials Conditions > BMS-247550 in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma

BMS-247550 in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma



BMS-247550 in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma

For Condition: recurrent adult diffuse large cell lymphoma,recurrent adult diffuse mixed cell lymphoma,recurrent mantle cell lymphoma,recurrent adult Burkitt's lymphoma,recurrent grade 3 follicular lymphoma,anaplastic large cell lymphoma
Status: Recruiting
Sponsor(s): University of Chicago Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy such as BMS-247550 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 refractoryaggressivenon-Hodgkin's lymphoma.
Details: OBJECTIVES: - Determine the objective overall response rate of patients with relapsed or refractory aggressive non-Hodgkin's lymphoma treated with BMS-247550. - Determine the safety and toxicity of this drug in these patients. - Determine the duration of response, overall survival, and time to progression in patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive BMS-247550 IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 8 weeks until disease progression. PROJECTED ACCRUAL: A total of 37-76 patients (22-46 for cohort 1 and 15-30 for cohort 2) will be accrued for this study within 12-18 months.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed aggressive non-Hodgkin's lymphoma of 1 of the following cellular types: - Grade III follicular center - Diffuse large B-cell - Mantle cell - Primary mediastinal B-cell - Burkitt's - High-grade B-cell (Burkitt-like) - Anaplastic large cell of 1 of the following subtypes: - CD30-positive - T-cell - Null cell - Hodgkin's-like - Relapsed or refractory disease after prior standard chemotherapy, meeting criteria for 1 of the following cohorts: - Cohort 1 (relapsed but chemosensitive): Prior complete response (CR) or partial response (PR) lasting at least 4 weeks after the most recent prior therapy - Cohort 2 (refractory): Prior CR or PR lasting less than 4 weeks after initial chemotherapy regimen - Measurable disease - At least 1 bidimensionally measurable lesion at least 10 mm by conventional techniques or clinical exam - Ineligible for or unwilling to undergo hematopoietic stem cell transplantation - No known CNS involvement by lymphoma - Prior CNS disease that has been successfully treated in patients with relapsed disease exclusively outside of the CNS may be allowed by the principal investigator PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - More than 3 months Hematopoietic - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,200/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 1.5 mg/dL - AST/ALT no greater than 2.5 times upper limit of normal Renal - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance at least 60 mL/min Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No prior allergic reaction or hypersensitivity to compounds containing Cremophor EL or agents of similar chemical or biological composition to BMS-247550 - No peripheral neuropathy grade 2 or greater - No other currently active malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix (previously treated malignancy allowed if considered to be at less than 30% risk of relapse) - No ongoing or active infection - No psychiatric illness or social situation that would preclude study compliance - No other concurrent uncontrolled illness PRIOR CONCURRENT THERAPY: Biologic therapy - No colony-stimulating factors (CSFs) within 24 hours of study chemotherapy - No CSFs during first course of study therapy - No concurrent filgrastim-SD/01 - No concurrent immunotherapy Chemotherapy - See Disease Characteristics - At least 4 weeks since prior cytotoxic chemotherapy (6 weeks for nitrosoureas or mitomycin) - No more than 1 prior chemotherapy regimen (cohort 2 only) - No other concurrent chemotherapy Endocrine therapy - No concurrent hormonal therapy Radiotherapy - At least 4 weeks since prior radiotherapy - No concurrent therapeutic radiotherapy Surgery - At least 4 weeks since prior surgery Other - Recovered from prior therapy - At least 7 days since prior cimetidine - No concurrent cimetidine - No concurrent combination antiretroviral therapy for HIV-positive patients - No other concurrent investigational agents - No other concurrent anticancer medications - No concurrent unconventional therapies, food, or vitamin supplements containing Hypericum perforatum
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
SonaliSmith,  Study Chair,  University of Chicago Cancer Research Center

Oncology/Hematology Associates of Central Illinois, P.C. *Recruiting*
Peoria,  Illinois,  61602
United States
Recruiting James  Knost 309-672-5681

Medical College of Wisconsin Cancer Center *Recruiting*
Milwaukee,  Wisconsin,  53226
United States
Recruiting Stuart  Wong 414-805-4603

LaGrange Memorial Hospital *Recruiting*
LaGrange,  Illinois,  60525
United States
Recruiting James  Hannigan 708-579-3418

CCOP - Northern Indiana CR Consortium *Recruiting*
South Bend,  Indiana,  46601
United States
Recruiting David  Taber 800-284-7370

Decatur Memorial Hospital Cancer Care Institute *Recruiting*
Decatur,  Illinois,  62526
United States
Recruiting James  Wade 217-876-6603

University of Chicago Cancer Research Center *Recruiting*
Chicago,  Illinois,  60637-1470
United States
Recruiting Koen  Besien 773-702-6696

Evanston Northwestern Health Care - Evanston Hospital *Recruiting*
Evanston,  Illinois,  60201-1781
United States
Recruiting Bruce  Brockstein 847-570-1489

Oncology Care Associates, P.L.L.C. *Recruiting*
Saint Joseph,  Michigan,  49085
United States
Recruiting Eric  Lester 269-985-0029

Fort Wayne Medical Oncology and Hematology, Incorporated *Recruiting*
Ft. Wayne,  Indiana,  46885-5099
United States
Recruiting David  Sciortino 219-484-8830

Louis A. Weiss Memorial Hospital *Recruiting*
Chicago,  Illinois,  60640
United States
Recruiting Stuart  Krauss 773-878-8700

Cardinal Bernardin Cancer Center at Loyola University Medical Center *Recruiting*
Maywood,  Illinois,  60153
United States
Recruiting Ellen  Gaynor 708-327-3101

Ingalls Memorial Hospital *Recruiting*
Harvey,  Illinois,  60426
United States
Recruiting Mark  Kozloff 708-333-2300

Central Illinois Hematology Oncology Center *Recruiting*
Springfield,  Illinois,  62701
United States
Recruiting Edem  Agamah 217-525-2500


Additional Information:
Study ID Numbers:
  CDR0000285683;  UCCRC-NCI-5913,NCI-5913,UCCRC-11965B
Study Start Date: 
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00058019

Other Recurrent Mantle Cell Lymphoma Studies:
1. Monoclonal Antibody Therapy in Treating Patients With Refractory Anaplastic Large Cell Lymphoma or Hodgkin's Lymphoma

2. Combination Chemotherapy in Treating Patients With Relapsed or Refractory Intermediate-Grade or High-Grade Non-Hodgkin's Lymphoma

3. Comparison of Two Combination Chemotherapy Regimens With Either Vincristine or Vinblastine in Treating Patients With Advanced Anaplastic Large Cell Lymphoma

4. Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Relapsed or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma

5. Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, and Radiation Therapy Followed By Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Stage I or Stage II Non-Hodgkin's Lymphoma

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