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A Phase II Study Of Epothilone B Analog BMS-247550 (NSC 710428) In Patients With Relapsed Aggressive Non-Hodgkin's Lymphomas


Phase 2
18 Years
N/A
Not Enrolling
Both
Anaplastic Large Cell Lymphoma, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma

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Trial Information

A Phase II Study Of Epothilone B Analog BMS-247550 (NSC 710428) In Patients With Relapsed Aggressive Non-Hodgkin's Lymphomas


OBJECTIVES:

I. Determine the objective overall response rate of patients with relapsed or refractory
aggressive non-Hodgkin's lymphoma treated with BMS-247550 (ixabepilone).

II. Determine the safety and toxicity of this drug in these patients. III. Determine the
duration of response, overall survival, and time to progression in patients treated with
this drug.

OUTLINE: This is a multi-center study.

Patients receive ixabepilone intravenously (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.


Inclusion Criteria:



- 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 1of 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

- Performance status - ECOG 0-2

- More than 3 months

- WBC at least 3,000/mm^3

- Absolute neutrophil count at least 1,200/mm^3

- Platelet count at least 100,000/mm^3

- Bilirubin no greater than 1.5 mg/dL

- AST/ALT no greater than 2.5 times upper limit of normal

- Creatinine no greater than 1.5 mg/dL

- Creatinine clearance at least 60 mL/min

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

- 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

- 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

- See Disease Characteristics

- At least 4 weeks since prior cytotoxic chemotherapy (6 weeks for nitrosoureas or
mitomycin)

- No other concurrent chemotherapy

- No concurrent hormonal therapy

- At least 4 weeks since prior radiotherapy

- No concurrent therapeutic radiotherapy

- At least 4 weeks since prior surgery

- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective overall response rate to intravenous administration of ixabepilone in patients with relapsed chemosensitive or refractory aggressive NHL

Outcome Description:

Each patient will be assigned one of the following categories: 1) complete response or CRu, 2) partial response, 3) stable disease, 4) progressive disease, 5) early death from malignant disease, 6) early death from toxicity, 7) early death because of other cause, or 9) unknown (not assessable, insufficient data). The 95% confidence intervals will be provided.

Outcome Time Frame:

Every 8 weeks and then 4 weeks following initial objective response

Safety Issue:

No

Principal Investigator

Sonali Smith

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00031

NCT ID:

NCT00058019

Start Date:

February 2003

Completion Date:

Related Keywords:

  • Anaplastic Large Cell Lymphoma
  • Recurrent Adult Burkitt Lymphoma
  • Recurrent Adult Diffuse Large Cell Lymphoma
  • Recurrent Adult Diffuse Mixed Cell Lymphoma
  • Recurrent Grade 3 Follicular Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Burkitt Lymphoma
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Anaplastic
  • Lymphoma, Mantle-Cell

Name

Location

University of Chicago Comprehensive Cancer CenterChicago, Illinois  60637-1470
M D Anderson Cancer CenterHouston, Texas  77030