Clinical trial NCT00058019: Ixabepilone in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
Official title: A Phase II Study of Epothilone B Analog BMS-247550 (NSC 710428) in Patients With Relapsed Aggressive Non-Hodgkin's Lymphomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-04-09
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This phase II trial is studying how well ixabepilone works in treating patients with relapsed or refractory aggressive non-Hodgkin's lymphoma. Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop cancer cells from dividing so they stop growing or die.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Objective Overall Response Rate
timeFrame: up to 3 years
measure: Safety and Toxicity of Ixabepilone
timeFrame: up to 3 years
Secondary outcomes:
measure: Duration of Response
timeFrame: up to 3 years
measure: Overall Survival
timeFrame: up to 3 years
measure: Time to Progression
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: University of Chicago
name: Sonali Smith
role: PRINCIPAL_INVESTIGATOR
References: