PXD101 in Treating Patients With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma
Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma
About this trial
This is an interventional treatment trial for Recurrent Adult Burkitt Lymphoma
Eligibility Criteria
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
Sites / Locations
- Providence Hospital
- University of Arizona Health Sciences Center
- NEA Baptist Memorial Hospital
- University of Arkansas for Medical Sciences
- East Bay Radiation Oncology Center
- Eden Hospital Medical Center
- Valley Medical Oncology Consultants-Castro Valley
- Valley Medical Oncology Consultants-Fremont
- Marin General Hospital
- Saint Rose Hospital
- Contra Costa Regional Medical Center
- Highland General Hospital
- Alta Bates Summit Medical Center - Summit Campus
- Bay Area Breast Surgeons Inc
- Bay Area Tumor Institute CCOP
- Larry G Strieff MD Medical Corporation
- Tom K Lee Inc
- Valley Care Health System - Pleasanton
- Valley Medical Oncology Consultants
- Doctors Medical Center- JC Robinson Regional Cancer Center
- Sutter Solano Medical Center
- Cancer Centers of Central Florida PA
- Decatur Memorial Hospital
- Advocate Sherman Hospital
- Loyola University Medical Center
- Memorial Medical Center
- Saint Francis Hospital and Health Centers
- Reid Hospital and Health Care Services
- Providence Medical Center
- Lawrence Memorial Hospital
- Menorah Medical Center
- Radiation Oncology Practice Corporation Southwest
- Salina Regional Health Center
- Shawnee Mission Medical Center
- Baton Rouge General Medical Center
- Mary Bird Perkins Cancer Center
- DeSoto Regional Health System
- Louisiana State University Sciences Center- Monroe
- Interim LSU Public Hospital
- Louisiana State University Health Science Center
- Highland Clinic
- Louisiana State University Health Sciences Center Shreveport
- Boston Medical Center
- Henry Ford Hospital
- Centerpoint Medical Center LLC
- Truman Medical Center
- Saint Luke's Cancer Institute
- Saint Luke's Hospital of Kansas City
- Radiation Oncology Practice Corporation South
- Saint Joseph Health Center
- North Kansas City Hospital
- Research Medical Center
- Radiation Oncology Practice Corporation - North
- Liberty Hospital
- Heartland Regional Medical Center
- Montana Cancer Consortium CCOP
- Northern Rockies Radiation Oncology Center
- Saint Vincent Healthcare
- Hematology-Oncology Centers of the Northern Rockies PC
- Billings Clinic
- Deaconess Medical Center
- Bozeman Deaconess Cancer Center
- Bozeman Deaconess Hospital
- Internal Medicine of Bozeman
- Saint James Community Hospital and Cancer Treatment Center
- Berdeaux, Donald MD (UIA Investigator)
- Great Falls Clinic
- Northern Montana Hospital
- Saint Peter's Community Hospital
- Glacier Oncology PLLC
- Kalispell Medical Oncology
- Kalispell Regional Medical Center
- Community Medical Hospital
- Montana Cancer Specialists
- Saint Patrick Hospital - Community Hospital
- Guardian Oncology and Center for Wellness
- Highland Hospital
- Wayne Radiation Oncology
- Wilson Medical Center
- University of Cincinnati
- Grandview Hospital
- Good Samaritan Hospital - Dayton
- Miami Valley Hospital
- Samaritan North Health Center
- Dayton CCOP
- Veteran Affairs Medical Center
- Blanchard Valley Hospital
- Atrium Medical Center-Middletown Regional Hospital
- Kettering Medical Center
- Upper Valley Medical Center
- Clinton Memorial Hospital
- Greene Memorial Hospital
- McLeod Regional Medical Center
- Brooke Army Medical Center
- Wilford Hall Medical Center
- Southwest Oncology Group
- American Fork Hospital
- Sandra L Maxwell Cancer Center
- Logan Regional Hospital
- Cottonwood Hospital Medical Center
- Intermountain Medical Center
- McKay-Dee Hospital Center
- Utah Valley Regional Medical Center
- Dixie Medical Center Regional Cancer Center
- Intermountain Health Care
- Utah Cancer Specialists-Salt Lake City
- LDS Hospital
- PeaceHealth Saint Joseph Medical Center
- Harrison HealthPartners Hematology and Oncology-Bremerton
- Columbia Basin Hematology and Oncology PLLC
- Skagit Valley Hospital
- Harborview Medical Center
- Minor and James Medical PLLC
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
- Group Health Cooperative-Seattle
- Swedish Medical Center-First Hill
- The Polyclinic
- University of Washington Medical Center
- United General Hospital
- Cancer Care Northwest - Spokane South
- Madigan Army Medical Center
- Wenatchee Valley Medical Center
- Welch Cancer Center
Arms of the Study
Arm 1
Experimental
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.