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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
Not Enrolling

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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


- 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.

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 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



- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- 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 OR

- 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


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


- See Disease Characteristics

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

- No other concurrent chemotherapy

Endocrine therapy

- 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:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective overall response rate

Safety Issue:


Principal Investigator

Sonali M. Smith, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago


United States: Food and Drug Administration

Study ID:




Start Date:

February 2003

Completion Date:

Related Keywords:

  • Lymphoma
  • 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
  • Lymphoma
  • Lymphoma, Non-Hodgkin