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BMS-247550 in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), October 2007
First Received: April 7, 2003   Last Updated: June 3, 2009   History of Changes
Sponsor: University of Chicago
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00058019
  Purpose

RATIONALE: Drugs used in chemotherapy, such as BMS-247550, work in different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well BMS-247550 works in treating patients with relapsed or refractory aggressive non-Hodgkin's lymphoma.


Condition Intervention Phase
Lymphoma
Drug: ixabepilone
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study Of Epothilone B Analog BMS-247550 (NSC 710428) In Patients With Relapsed Aggressive Non-Hodgkin's Lymphomas

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective overall response rate [ Designated as safety issue: No ]
  • Safety [ Designated as safety issue: Yes ]
  • Toxicity [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Duration of response [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Time to progression [ Designated as safety issue: No ]

Estimated Enrollment: 76
Study Start Date: February 2003
Estimated Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
Detailed Description:

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, unacceptable toxicity, or if the patient becomes a candidate for stem cell transplantation.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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): Stable disease or less than a PR after the most recent prior therapy

      • No progressive disease after the most recent prior therapy
  • 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

    • Patients requiring debulking prior to transplant allowed
  • 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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00058019

Locations
United States, Illinois
Cardinal Bernardin Cancer Center at Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Clinical Trials Office - Cardinal Bernardin Cancer Center     708-226-4357        
Central Illinois Hematology Oncology Center Recruiting
Springfield, Illinois, United States, 62701
Contact: Edem S. Agamah, MD, MS     217-525-2500     ihdn@aol.com    
Decatur Memorial Hospital Cancer Care Institute Recruiting
Decatur, Illinois, United States, 62526
Contact: Clinical Trials Office - Decatur Memorial Hospital Cancer Care     217-876-6601        
La Grange Memorial Hospital Recruiting
La Grange, Illinois, United States, 60525
Contact: Clinical Trials Office - La Grange Memorial Hospital     630-856-7526        
Ingalls Cancer Care Center at Ingalls Memorial Hospital Recruiting
Harvey, Illinois, United States, 60426
Contact: Clinical Trials Office - Ingalls Cancer Care Center at Ingalls     708-915-6747        
Evanston Hospital Recruiting
Evanston, Illinois, United States, 60201-1781
Contact: Clinical Trials Office - Evanston Hospital     847-570-1381        
Louis A. Weiss Memorial Hospital Recruiting
Chicago, Illinois, United States, 60640
Contact: Clinical Trials Office - Louis A. Weiss Memorial Hospital     773-564-5044        
Oncology Hematology Associates of Central Illinois, PC - Peoria Recruiting
Peoria, Illinois, United States, 61615-7828
Contact: James A. Knost, MD, FACP     309-243-3000        
University of Chicago Cancer Research Center Recruiting
Chicago, Illinois, United States, 60637-1470
Contact: Clinical Trials Office - University of Chicago Cancer Research     773-834-7424        
United States, Indiana
CCOP - Northern Indiana CR Consortium Recruiting
South Bend, Indiana, United States, 46601
Contact: David A. Taber, MD     574-647-3353        
Fort Wayne Medical Oncology and Hematology Recruiting
Fort Wayne, Indiana, United States, 46885-5099
Contact: David F. Sciortino, MD     260-484-8830        
United States, Michigan
Oncology Care Associates, PLLC Recruiting
Saint Joseph, Michigan, United States, 49085
Contact: Eric P. Lester, MD     269-985-0029        
United States, Wisconsin
Medical College of Wisconsin Cancer Center Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Clinical Trials Office - Medical College of Wisconsin Cancer C     414-805-4380        
Sponsors and Collaborators
University of Chicago
Investigators
Study Chair: Sonali M. Smith, MD University of Chicago
  More Information

Additional Information:
No publications provided

Responsible Party: Mayo Clinic Cancer Center ( Charles Erlichman )
Study ID Numbers: CDR0000285683, UCCRC-11965B, NCI-5913, UCCRC-NCI-5913
Study First Received: April 7, 2003
Last Updated: June 3, 2009
ClinicalTrials.gov Identifier: NCT00058019     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent grade 3 follicular lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult Burkitt lymphoma
recurrent mantle cell lymphoma
anaplastic large cell lymphoma

Additional relevant MeSH terms:
Lymphatic Diseases
Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

ClinicalTrials.gov processed this record on November 27, 2009