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

April 7, 2003
June 3, 2009
February 2003
May 2004   (final data collection date for primary outcome measure)
  • Objective overall response rate [ Designated as safety issue: No ]
  • Safety [ Designated as safety issue: Yes ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Objective overall response rate
  • Safety
  • Toxicity
Complete list of historical versions of study NCT00058019 on ClinicalTrials.gov Archive Site
  • Duration of response [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Time to progression [ Designated as safety issue: No ]
  • Duration of response
  • Overall survival
  • Time to progression
 
BMS-247550 in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
A Phase II Study Of Epothilone B Analog BMS-247550 (NSC 710428) In Patients With Relapsed Aggressive Non-Hodgkin's Lymphomas

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.

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.

Phase II
Interventional
Treatment, Open Label
Lymphoma
Drug: ixabepilone
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
76
 
May 2004   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
 
United States
 
NCT00058019
Charles Erlichman, Mayo Clinic Cancer Center
CDR0000285683, UCCRC-11965B, NCI-5913, UCCRC-NCI-5913
University of Chicago
National Cancer Institute (NCI)
Study Chair: Sonali M. Smith, MD University of Chicago
National Cancer Institute (NCI)
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP