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PXD101 in Treating Patients W...

PXD101 in Treating Patients With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma

Last Updated: 2014-05-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2010-08-31

Brief Summary

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This phase II trial is studying how well PXD101 works in treating patients with relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma. PXD101 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.

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Detailed Description

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PRIMARY OBJECTIVES:

I. Evaluate response rate in patients with relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma treated with PXD101.

SECONDARY OBJECTIVES:

I. Determine the toxicity of this drug in these patients. II. Estimate the 6-month progression-free survival rate in patients treated with this drug.

TERTIARY OBJECTIVES:

I. Determine the major histocompatability complex of class II proteins (HLA-DR, -DP, -DQ), TUNEL, and CD8 infiltration status, by immunochemistry on paired pre- and post-treatment tumor samples, in the first 20 patients enrolled.

II. Measure CIITA and HLA-DR mRNA expression using quantitative reverse transcriptase-polymerase chain reaction and determine, preliminarily, the associations of these markers with progression-free survival.

III. Evaluate paired pre- and post-treatment peripheral blood mononuclear cells from patients for histone acetylation status and determine correlation with findings from duplicate experiments on pre- and post-needle core biopsies.

OUTLINE: This is a multicenter study.

Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Needle core biopsies and peripheral blood mononuclear cells are obtained from the first 20 patients pre- and post-treatment for biomarker correlative studies.

After completion of study treatment, patients are followed every 3-6 months for up to 3 years.

Conditions

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Recurrent Adult Burkitt Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm I

Patients will receive an infusion of PXD101 once a day for 5 days. Treatment may repeat every 3 weeks for up to 2 years. Some patients will also undergo core biopsy and blood collection for laboratory studies before and after treatment.

After finishing treatment, patients will be evaluated every 3-6 months for up to 3 years.

Group Type EXPERIMENTAL

belinostat

Intervention Type DRUG

Given IV

Interventions

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belinostat

Given IV

Intervention Type DRUG

Other Intervention Names

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PXD101

Eligibility Criteria

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Inclusion Criteria

* Biopsy-proven (no needle aspirations or cytologies) aggressive B-cell non-Hodgkin's lymphoma (NHL), including 1 of the following histology subtypes:

* Diffuse large cell NHL
* Burkitt's or Burkitt-like NHL
* Primary mediastinal NHL
* Relapsed or refractory disease
* Bidimensionally measurable disease
* Transformed NHL allowed
* Not eligible for stem cell transplantation (for patients registered to study at first relapse)
* No active CNS involvement by lymphoma
* Zubrod performance status 0-2
* No history of allergic reactions attributed to compounds of similar chemical or biologic composition to PXD101
* Absolute neutrophil count \>= 1,500/mm\^3
* Platelet count\>=100,000/mm\^3
* WBC \>= 3,000/mm\^3
* Creatinine \< 2 times upper limit of normal (ULN) OR creatinine clearance \>= 60 mL/min
* No significant EKG abnormalities
* Bilirubin normal
* SGOT/SGPT \< 2.5 times ULN (=\< 5 times ULN if liver involvement)
* No long QT syndrome or marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of QTc interval \> 500 msec)
* No other significant cardiovascular disease, including any of the following:

* Unstable angina pectoris
* Uncontrolled hypertension
* Congestive heart failure related to primary cardiac disease
* Any condition requiring anti-arrhythmic therapy
* Ischemic or severe valvular heart disease
* Myocardial infarction within the past 6 months
* No major surgery within 28 days prior to study entry
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No concurrent medication that may cause Torsades de Pointes (i.e., prolongation of the QT interval \> 500 msec)
* At least 14 days since prior radiotherapy
* At least 2 weeks since prior valproic acid or any other histone deacetylase inhibitor
* No clinical evidence of any of the following:

* Severe peripheral vascular disease
* Diabetic ulcers or venous stasis ulcers
* History of deep venous or arterial thrombosis within the past 3 months
* Radioimmunotherapy is considered a chemotherapy regimen
* Single-agent rituximab is not considered a chemotherapy regimen
* Standard salvage chemotherapy followed by autologous stem cell transplantation is considered 1 regimen
* No known AIDS or HIV-associated complex
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or in situ carcinoma of the cervix
* At least 2 weeks since prior therapy and recovered
* No more than 5 prior chemotherapy regimens

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven Bernstein

Role: PRINCIPAL_INVESTIGATOR

SWOG Cancer Research Network

Locations

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Providence Hospital

Mobile, Alabama, United States

Site Status

University of Arizona Health Sciences Center

Tucson, Arizona, United States

Site Status

NEA Baptist Memorial Hospital

Jonesboro, Arkansas, United States

Site Status

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

East Bay Radiation Oncology Center

Castro Valley, California, United States

Site Status

Eden Hospital Medical Center

Castro Valley, California, United States

Site Status

Valley Medical Oncology Consultants-Castro Valley

Castro Valley, California, United States

Site Status

Valley Medical Oncology Consultants-Fremont

Fremont, California, United States

Site Status

Marin General Hospital

Greenbrae, California, United States

Site Status

Saint Rose Hospital

Hayward, California, United States

Site Status

Contra Costa Regional Medical Center

Martinez, California, United States

Site Status

Highland General Hospital

Oakland, California, United States

Site Status

Alta Bates Summit Medical Center - Summit Campus

Oakland, California, United States

Site Status

Bay Area Breast Surgeons Inc

Oakland, California, United States

Site Status

Bay Area Tumor Institute CCOP

Oakland, California, United States

Site Status

Larry G Strieff MD Medical Corporation

Oakland, California, United States

Site Status

Tom K Lee Inc

Oakland, California, United States

Site Status

Valley Care Health System - Pleasanton

Pleasanton, California, United States

Site Status

Valley Medical Oncology Consultants

Pleasanton, California, United States

Site Status

Doctors Medical Center- JC Robinson Regional Cancer Center

San Pablo, California, United States

Site Status

Sutter Solano Medical Center

Vallejo, California, United States

Site Status

Cancer Centers of Central Florida PA

Leesburg, Florida, United States

Site Status

Decatur Memorial Hospital

Decatur, Illinois, United States

Site Status

Advocate Sherman Hospital

Elgin, Illinois, United States

Site Status

Loyola University Medical Center

Maywood, Illinois, United States

Site Status

Memorial Medical Center

Springfield, Illinois, United States

Site Status

Saint Francis Hospital and Health Centers

Beech Grove, Indiana, United States

Site Status

Reid Hospital and Health Care Services

Richmond, Indiana, United States

Site Status

Providence Medical Center

Kansas City, Kansas, United States

Site Status

Lawrence Memorial Hospital

Lawrence, Kansas, United States

Site Status

Menorah Medical Center

Overland Park, Kansas, United States

Site Status

Radiation Oncology Practice Corporation Southwest

Overland Park, Kansas, United States

Site Status

Salina Regional Health Center

Salina, Kansas, United States

Site Status

Shawnee Mission Medical Center

Shawnee Mission, Kansas, United States

Site Status

Baton Rouge General Medical Center

Baton Rouge, Louisiana, United States

Site Status

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, United States

Site Status

DeSoto Regional Health System

Mansfield, Louisiana, United States

Site Status

Louisiana State University Sciences Center- Monroe

Monroe, Louisiana, United States

Site Status

Interim LSU Public Hospital

New Orleans, Louisiana, United States

Site Status

Louisiana State University Health Science Center

New Orleans, Louisiana, United States

Site Status

Highland Clinic

Shreveport, Louisiana, United States

Site Status

Louisiana State University Health Sciences Center Shreveport

Shreveport, Louisiana, United States

Site Status

Boston Medical Center

Boston, Massachusetts, United States

Site Status

Henry Ford Hospital

Detroit, Michigan, United States

Site Status