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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
Sponsors and Collaborators: University of Chicago
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

MedlinePlus related topics: Cancer Lymphoma
Drug Information available for: Epothilone B Ixabepilone
U.S. FDA Resources
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

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 Northwestern Healthcare - Evanston Hospital Recruiting
Evanston, Illinois, United States, 60201-1781
Contact: Clinical Trials Office - Evanston Northwestern Healthcare - Ev     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

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000285683, UCCRC-11965B, NCI-5913, UCCRC-NCI-5913
Study First Received: April 7, 2003
Last Updated: October 22, 2008
ClinicalTrials.gov Identifier: NCT00058019  
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

Study placed in the following topic categories:
Epothilone B
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Epothilones
Lymphoma, Mantle-Cell
Lymphoma, Follicular
Lymphoma, small cleaved-cell, diffuse
Mantle cell lymphoma
Recurrence
Lymphoma, large-cell
Burkitt's lymphoma
Lymphatic Diseases
Burkitt Lymphoma
Lymphoma, Large-Cell, Anaplastic
Anaplastic large cell lymphoma
Lymphoma, Non-Hodgkin
Aggression
Lymphoproliferative Disorders
Lymphoma
Follicular lymphoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009