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

This study is currently recruiting patients.

Sponsors and Collaborators: University of Chicago Cancer Research Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

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: Phase II trial to study the effectiveness of BMS-247550 in treating patients who have relapsed or refractory aggressive non-Hodgkin's lymphoma.

Condition Treatment or Intervention Phase
recurrent grade 3 follicular lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult Burkitt's lymphoma
recurrent mantle cell lymphoma
anaplastic large cell lymphoma
 Drug: ixabepilone
 Procedure: chemotherapy
Phase II

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Lymphatic Diseases;   Lymphoma;   Viral Infections

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of BMS-247550 in Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma

Further Study Details: 

OBJECTIVES:

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 above,  Genders Eligible for Study:  Both

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
  • 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

Location and Contact Information


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

      Central Illinois Hematology Oncology Center, Springfield,  Illinois,  62701,  United States; Recruiting
Edem S. Agamah, MD, MS  217-525-2500    ihdn@aol.com 

      Decatur Memorial Hospital Cancer Care Institute, Decatur,  Illinois,  62526,  United States; Recruiting
James L. Wade, MD  217-876-6603 

      Evanston Northwestern Health Care - Evanston Hospital, Evanston,  Illinois,  60201-1781,  United States; Recruiting
Bruce E. Brockstein, MD  847-570-2515    b-brockstein@northwestern.edu 

      Ingalls Cancer Care Center at Ingalls Memorial Hospital, Harvey,  Illinois,  60426,  United States; Recruiting
Mark F. Kozloff, MD  708-333-2300 ext. 6849    mfkozloff@aol.com 

      La Grange Memorial Hospital, La Grange,  Illinois,  60525,  United States; Recruiting
James E. Hannigan, MD  708-579-3418    jhannigan@lagrangeoncology.com 

      Louis A. Weiss Memorial Hospital, Chicago,  Illinois,  60640,  United States; Recruiting
Stuart A. Krauss, MD  773-564-5020 

      Oncology/Hematology Associates of Central Illinois, P.C., Peoria,  Illinois,  61615-7828,  United States; Recruiting
James A. Knost, MD, FACP  309-672-5681 

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

Indiana
      CCOP - Northern Indiana CR Consortium, South Bend,  Indiana,  46601,  United States; Recruiting
David Allen Taber, MD  574-647-3353 

      Fort Wayne Medical Oncology and Hematology, Incorporated, Fort Wayne,  Indiana,  46885-5099,  United States; Recruiting
David Frank Sciortino, MD  260-484-8830 

Michigan
      Oncology Care Associates, P.L.L.C., Saint Joseph,  Michigan,  49085,  United States; Recruiting
Eric P. Lester, MD  269-985-0029    oncology@parrett.net 

Wisconsin
      Medical College of Wisconsin Cancer Center, Milwaukee,  Wisconsin,  53226,  United States; Recruiting
Stuart J. Wong, MD  414-805-4603 

Study chairs or principal investigators

Sonali Mehta Smith, MD,  Study Chair,  University of Chicago Cancer Research Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000285683; UCCRC-11965B; NCI-5913; UCCRC-NCI-5913; NCT00058019
Record last reviewed:  May 2004
Last Updated:  April 4, 2005
Record first received:  April 7, 2003
ClinicalTrials.gov Identifier:  NCT00058019
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005