Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Objectives

1. Determine the objective overall response rate of patients with relapsed or refractory aggressive non-Hodgkin's lymphoma treated with BMS-247550.
2. Determine the safety and toxicity of this drug in these patients.
3. Determine the duration of response, overall survival, and time to progression in patients treated with this drug.

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): 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• More than 3 months

Hematopoietic

• WBC at least 3,000/mm³
• Absolute neutrophil count at least 1,200/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

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.

Outcomes

Objective overall response rate
Safety
Toxicity

Duration of response
Overall survival
Time to progression

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.

Trial Contact Information

Trial Lead Organizations

University of Chicago Cancer Research Center

Sonali Smith, MD, Protocol chair		Ph: 773-834-2895; 888-824-0200

Registry Information
Official Title		A Phase II Study Of Epothilone B Analog BMS-247550 (NSC 710428) In Patients With Relapsed Aggressive Non-Hodgkin's Lymphomas
Trial Start Date		2003-02-27
Trial Completion Date		2010-08-17
Registered in ClinicalTrials.gov		NCT00058019
Date Submitted to PDQ		2003-02-12
Information Last Verified		2007-10-11
NCI Grant/Contract Number		CA14599, CM17102

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