Spots Global Cancer Trial Database for PXD101 in Treating Patients With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma
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Trial Identification
Brief Title: PXD101 in Treating Patients With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma
Official Title: Phase II Study of PXD101 (NSC-726630) in Relapsed and Refractory Aggressive B-Cell Lymphomas
Study ID: NCT00303953
Interventions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Providence Hospital, Mobile, Alabama, United States
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
Memorial Medical Center, Springfield, Illinois, United States
Saint Francis Hospital and Health Centers, Beech Grove, Indiana, United States
Reid Hospital and Health Care Services, Richmond, Indiana, United States
Providence Medical Center, Kansas City, Kansas, United States
Lawrence Memorial Hospital, Lawrence, Kansas, United States
Menorah Medical Center, Overland Park, Kansas, United States
Radiation Oncology Practice Corporation Southwest, Overland Park, Kansas, United States
Salina Regional Health Center, Salina, Kansas, United States
Shawnee Mission Medical Center, Shawnee Mission, Kansas, United States
Baton Rouge General Medical Center, Baton Rouge, Louisiana, United States
Mary Bird Perkins Cancer Center, Baton Rouge, Louisiana, United States
DeSoto Regional Health System, Mansfield, Louisiana, United States
Louisiana State University Sciences Center- Monroe, Monroe, Louisiana, United States
Interim LSU Public Hospital, New Orleans, Louisiana, United States
Louisiana State University Health Science Center, New Orleans, Louisiana, United States
Highland Clinic, Shreveport, Louisiana, United States
Louisiana State University Health Sciences Center Shreveport, Shreveport, Louisiana, United States
Boston Medical Center, Boston, Massachusetts, United States
Henry Ford Hospital, Detroit, Michigan, United States
Centerpoint Medical Center LLC, Independence, Missouri, United States
Truman Medical Center, Kansas City, Missouri, United States
Saint Luke's Cancer Institute, Kansas City, Missouri, United States
Saint Luke's Hospital of Kansas City, Kansas City, Missouri, United States
Radiation Oncology Practice Corporation South, Kansas City, Missouri, United States
Saint Joseph Health Center, Kansas City, Missouri, United States
North Kansas City Hospital, Kansas City, Missouri, United States
Research Medical Center, Kansas City, Missouri, United States
Radiation Oncology Practice Corporation - North, Kansas City, Missouri, United States
Liberty Hospital, Liberty, Missouri, United States
Heartland Regional Medical Center, Saint Joseph, Missouri, United States
Montana Cancer Consortium CCOP, Billings, Montana, United States
Northern Rockies Radiation Oncology Center, Billings, Montana, United States
Saint Vincent Healthcare, Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies PC, Billings, Montana, United States
Billings Clinic, Billings, Montana, United States
Deaconess Medical Center, Billings, Montana, United States
Bozeman Deaconess Cancer Center, Bozeman, Montana, United States
Bozeman Deaconess Hospital, Bozeman, Montana, United States
Internal Medicine of Bozeman, Bozeman, Montana, United States
Saint James Community Hospital and Cancer Treatment Center, Butte, Montana, United States
Berdeaux, Donald MD (UIA Investigator), Great Falls, Montana, United States
Great Falls Clinic, Great Falls, Montana, United States
Northern Montana Hospital, Havre, Montana, United States
Saint Peter's Community Hospital, Helena, Montana, United States
Glacier Oncology PLLC, Kalispell, Montana, United States
Kalispell Medical Oncology, Kalispell, Montana, United States
Kalispell Regional Medical Center, Kalispell, Montana, United States
Community Medical Hospital, Missoula, Montana, United States
Montana Cancer Specialists, Missoula, Montana, United States
Saint Patrick Hospital - Community Hospital, Missoula, Montana, United States
Guardian Oncology and Center for Wellness, Missoula, Montana, United States
Highland Hospital, Rochester, New York, United States
Wayne Radiation Oncology, Goldsboro, North Carolina, United States
Wilson Medical Center, Wilson, North Carolina, United States
University of Cincinnati, Cincinnati, Ohio, United States
Grandview Hospital, Dayton, Ohio, United States
Good Samaritan Hospital - Dayton, Dayton, Ohio, United States
Miami Valley Hospital, Dayton, Ohio, United States
Samaritan North Health Center, Dayton, Ohio, United States
Dayton CCOP, Dayton, Ohio, United States
Veteran Affairs Medical Center, Dayton, Ohio, United States
Blanchard Valley Hospital, Findlay, Ohio, United States
Atrium Medical Center-Middletown Regional Hospital, Franklin, Ohio, United States
Kettering Medical Center, Kettering, Ohio, United States
Upper Valley Medical Center, Troy, Ohio, United States
Clinton Memorial Hospital, Wilmington, Ohio, United States
Greene Memorial Hospital, Xenia, Ohio, United States
McLeod Regional Medical Center, Florence, South Carolina, United States
Brooke Army Medical Center, Fort Sam Houston, Texas, United States
Wilford Hall Medical Center, Lackland AFB, Texas, United States
Southwest Oncology Group, San Antonio, Texas, United States
American Fork Hospital, American Fork, Utah, United States
Sandra L Maxwell Cancer Center, Cedar City, Utah, United States
Logan Regional Hospital, Logan, Utah, United States
Cottonwood Hospital Medical Center, Murray, Utah, United States
Intermountain Medical Center, Murray, Utah, United States
McKay-Dee Hospital Center, Ogden, Utah, United States
Utah Valley Regional Medical Center, Provo, Utah, United States
Dixie Medical Center Regional Cancer Center, Saint George, Utah, United States
Intermountain Health Care, Salt Lake City, Utah, United States
Utah Cancer Specialists-Salt Lake City, Salt Lake City, Utah, United States
LDS Hospital, Salt Lake City, Utah, United States
PeaceHealth Saint Joseph Medical Center, Bellingham, Washington, United States
Harrison HealthPartners Hematology and Oncology-Bremerton, Bremerton, Washington, United States
Columbia Basin Hematology and Oncology PLLC, Kennewick, Washington, United States
Skagit Valley Hospital, Mount Vernon, Washington, United States
Harborview Medical Center, Seattle, Washington, United States
Minor and James Medical PLLC, Seattle, Washington, United States
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States
Group Health Cooperative-Seattle, Seattle, Washington, United States
Swedish Medical Center-First Hill, Seattle, Washington, United States
The Polyclinic, Seattle, Washington, United States
University of Washington Medical Center, Seattle, Washington, United States
United General Hospital, Sedro-Woolley, Washington, United States
Cancer Care Northwest - Spokane South, Spokane, Washington, United States
Madigan Army Medical Center, Tacoma, Washington, United States
Wenatchee Valley Medical Center, Wenatchee, Washington, United States
Welch Cancer Center, Sheridan, Wyoming, United States
Contact Details
Name: Steven Bernstein
Affiliation: SWOG Cancer Research Network
Role: PRINCIPAL_INVESTIGATOR
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