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

Completed · Phase 2

Conditions studied: Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma

In brief

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.

Key facts

Study ID

NCT00303953

Run by

National Cancer Institute (NCI)

People needed

22

Starts

2006-01-01

Expected to finish

2010-08-01

Last updated by the study team

2014-05-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• University of Arizona Health Sciences Center — Tucson, Arizona, United States
• NEA Baptist Memorial Hospital — Jonesboro, Arkansas, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• East Bay Radiation Oncology Center — Castro Valley, California, United States
• Eden Hospital Medical Center — Castro Valley, California, United States
• Valley Medical Oncology Consultants-Castro Valley — Castro Valley, California, United States
• Valley Medical Oncology Consultants-Fremont — Fremont, California, United States
• Marin General Hospital — Greenbrae, California, United States
• Saint Rose Hospital — Hayward, California, United States
• Contra Costa Regional Medical Center — Martinez, California, United States
• Highland General Hospital — Oakland, California, United States
• Alta Bates Summit Medical Center - Summit Campus — Oakland, California, United States
• Bay Area Breast Surgeons Inc — Oakland, California, United States
• Bay Area Tumor Institute CCOP — Oakland, California, United States
• Larry G Strieff MD Medical Corporation — Oakland, California, United States
• Tom K Lee Inc — Oakland, California, United States
• Valley Care Health System - Pleasanton — Pleasanton, California, United States
• Valley Medical Oncology Consultants — Pleasanton, California, United States
• Doctors Medical Center- JC Robinson Regional Cancer Center — San Pablo, California, United States
• Sutter Solano Medical Center — Vallejo, California, United States
• Cancer Centers of Central Florida PA — Leesburg, Florida, United States
• Decatur Memorial Hospital — Decatur, Illinois, United States
• Advocate Sherman Hospital — Elgin, Illinois, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Providence Hospital — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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