Mode
Text Size
Log in / Sign up
Phase 2 N=51 Treatment

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

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

Enrolled (actual)
51
Serious AEs
21.6%
Results posted
Feb 2014
Primary outcome: Primary: Objective Overall Response Rate — 14; 0 participants — p=0.022

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
ixabepilone (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
National Cancer Institute (NCI)
Primary completion
Aug 2010

Outcome Measures

OutcomeResultp-value
PRIMARY
Objective Overall Response Rate
14; 0 0.022 sig
PRIMARY
Safety and Toxicity of Ixabepilone
27; 8 1.00
SECONDARY
Duration of Response
291
SECONDARY
Overall Survival
501; 98 0.695
SECONDARY
Time to Progression
112; 84 0.55

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00058019). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search