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

NCT ID: NCT00058019

Last Updated: 2014-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-02-28
• Study Completion Date: 2010-08-31

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (chemotherapy)

Patients receive ixabepilone 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.

Group Type: EXPERIMENTAL

ixabepilone

Intervention Type: DRUG

Given IV

Interventions

ixabepilone

Given IV

Intervention Type: DRUG

Other Intervention Names

BMS-247550; epothilone B lactam; Ixempra

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sonali Smith

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago

Chicago, Illinois, United States

M D Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Other Identifiers

NCI-2009-00031

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-5913

Identifier Type: -

Identifier Source: secondary_id

UCCRC-NCI-5913

Identifier Type: -

Identifier Source: secondary_id

CDR0000285683

Identifier Type: -

Identifier Source: secondary_id

UCCRC-11965B

Identifier Type: -

Identifier Source: secondary_id

11965B

Identifier Type: OTHER

Identifier Source: secondary_id

5913

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA014599

Identifier Type: NIH

Identifier Source: secondary_id

View Link

N01CM62202

Identifier Type: NIH

Identifier Source: secondary_id

View Link

N01CM62201

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2009-00031

Identifier Type: -

Identifier Source: org_study_id

NCT01660269

Identifier Type: -

Identifier Source: nct_alias