Phase II Study of PXD101 (NSC-726630) in Relapsed and Refractory Aggressive B-Cell Lymphomas
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.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)
Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the SPD for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.
assessed at week 8, and every 3 months for 3 years
No
Steven Bernstein
Principal Investigator
Southwest Oncology Group
United States: Food and Drug Administration
NCI-2009-01096
NCT00303953
January 2006
Name | Location |
---|---|
Louisiana State University | New Orleans, Louisiana 70112-2282 |
University of Washington Medical Center | Seattle, Washington 98195-6043 |
Loyola University Medical Center | Maywood, Illinois 60153 |
Henry Ford Hospital | Detroit, Michigan 48202 |
Mary Bird Perkins Cancer Center | Baton Rouge, Louisiana 70809 |
LDS Hospital | Salt Lake City, Utah 84143 |
University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Boston Medical Center | Boston, Massachusetts 02118 |
Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
Madigan Army Medical Center | Tacoma, Washington 98431-5048 |
Group Health Cooperative | Seattle, Washington 98112 |
Great Falls Clinic | Great Falls, Montana 59405 |
Wilford Hall Medical Center | Lackland Air Force Base, Texas 78236-5300 |
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |
Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
Bozeman Deaconess Hospital | Bozeman, Montana 59715 |
Kalispell Medical Oncology | Kalispell, Montana 59901 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
American Fork Hospital | American Fork, Utah 84003 |
Logan Regional Hospital | Logan, Utah 84321 |
Cottonwood Hospital Medical Center | Murray, Utah 84107 |
McKay-Dee Hospital Center | Ogden, Utah 84403 |
Harborview Medical Center | Seattle, Washington 98104 |
Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
Welch Cancer Center | Sheridan, Wyoming 82801 |
Saint Rose Hospital | Hayward, California 94545 |
Alta Bates Summit Medical Center - Summit Campus | Oakland, California 94609 |
Sutter Solano Medical Center | Vallejo, California 94589 |
Salina Regional Health Center | Salina, Kansas 67401 |
Wayne Radiation Oncology | Goldsboro, North Carolina 27534 |
Wilson Medical Center | Wilson, North Carolina 27893-3428 |
Grandview Hospital | Dayton, Ohio 45405 |
Highland General Hospital | Oakland, California 94602 |
Miami Valley Hospital | Dayton, Ohio 45409 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Menorah Medical Center | Overland Park, Kansas 66209 |
Shawnee Mission Medical Center | Shawnee Mission, Kansas 66204 |
North Kansas City Hospital | Kansas City, Missouri 64116 |
Research Medical Center | Kansas City, Missouri 64132 |
Heartland Regional Medical Center | Saint Joseph, Missouri 64506 |
Bozeman Deaconess Cancer Center | Bozeman, Montana 59715 |
Northern Montana Hospital | Havre, Montana 59501 |
Clinton Memorial Hospital | Wilmington, Ohio 45177 |
Wenatchee Valley Medical Center | Wenatchee, Washington 98801-2028 |
Baton Rouge General Medical Center | Baton Rouge, Louisiana 70821-2511 |
Greene Memorial Hospital | Xenia, Ohio 45385 |
Sherman Hospital | Elgin, Illinois 60120-2198 |
Memorial Medical Center | Springfield, Illinois 62781 |
McLeod Regional Medical Center | Florence, South Carolina 29501 |
Guardian Oncology and Center for Wellness | Missoula, Montana 59804 |
Providence Hospital | Mobile, Alabama 36608 |
Providence Medical Center | Kansas City, Kansas 66112 |
Independence Regional Health Center | Independence, Missouri 64050 |
East Bay Radiation Oncology Center | Castro Valley, California 94546 |
Contra Costa Regional Medical Center | Martinez, California 94553-3156 |
Larry G Strieff MD Medical Corporation | Oakland, California 94609 |
University of Arizona Health Sciences Center | Tucson, Arizona 85724 |
Montana Cancer Consortium CCOP | Billings, Montana 59101 |
Decatur Memorial Hospital | Decatur, Illinois 62526 |
Louisiana State University Health Science Center | New Orleans, Louisiana 70112 |
Montana Cancer Specialists | Missoula, Montana 59807-7877 |
University of Cincinnati | Cincinnati, Ohio 45267-0502 |
Valley Medical Oncology Consultants-Castro Valley | Castro Valley, California 94546 |
Eden Hospital Medical Center | Castro Valley, California 94546 |
Valley Medical Oncology Consultants-Fremont | Fremont, California 94538 |
Bay Area Breast Surgeons Inc | Oakland, California 94609 |
Bay Area Tumor Institution CCOP | Oakland, California 94609 |
Tom K Lee Inc | Oakland, California 94609 |
Valley Medical Oncology Consultants | Pleasanton, California 94588 |
Valley Care Health System - Pleasanton | Pleasanton, California 94588 |
Doctors Medical Center- JC Robinson Regional Cancer Center | San Pablo, California 94806 |
Cancer Centers of Central Florida PA | Leesburg, Florida 34788 |
Saint Francis Hospital and Health Centers | Beech Grove, Indiana 46107 |
Reid Hospital and Health Care Services | Richmond, Indiana 47374 |
Radiation Oncology Practice Corporation Southwest | Overland Park, Kansas 66210 |
DeSoto Regional Health System | Mansfield, Louisiana 71052 |
Louisiana State University Sciences Center- Monroe | Monroe, Louisiana 71210 |
Medical Center of Louisiana | New Orleans, Louisiana 70112 |
Highland Clinic | Shreveport, Louisiana 71105 |
Radiation Oncology Practice Corporation - North | Kansas City, Missouri 64154 |
Saint Luke's Cancer Institute | Kansas City, Missouri 64111 |
Radiation Oncology Practice Corporation South | Kansas City, Missouri 64114 |
Saint Luke's Hospital of Kansas City | Kansas City, Missouri 64111 |
Saint Joseph Health Center | Kansas City, Missouri 64114 |
Liberty Radiation Oncology Clinic | Kansas City, Missouri 64116 |
Truman Medical Center | Kansas City, Missouri 64108 |
Hematology-Oncology Centers of the Northern Rockies PC | Billings, Montana 59101 |
Saint Vincent Healthcare | Billings, Montana 59101 |
Deaconess Medical Center | Billings, Montana 59107 |
Billings Clinic | Billings, Montana 59107-7000 |
Internal Medicine of Bozeman | Bozeman, Montana 59715 |
Saint James Community Hospital and Cancer Treatment Center | Butte, Montana 59701 |
Berdeaux, Donald MD (UIA Investigator) | Great Falls, Montana 59405 |
Saint Peter's Community Hospital | Helena, Montana 59601 |
Glacier Oncology PLLC | Kalispell, Montana 59901 |
Community Medical Hospital | Missoula, Montana 59801 |
Saint Patrick Hospital - Community Hospital | Missoula, Montana 59802 |
Highland Hospital | Rochester, New York 14620 |
Good Samaritan Hospital - Dayton | Dayton, Ohio 45406 |
Dayton CCOP | Dayton, Ohio 45429 |
Samaritan North Health Center | Dayton, Ohio 45415 |
Veteran Affairs Medical Center | Dayton, Ohio 45428 |
Blanchard Valley Hospital | Findlay, Ohio 45840 |
Atrium Medical Center-Middletown Regional Hospital | Franklin, Ohio 45005-1066 |
Kettering Medical Center | Kettering, Ohio 45429 |
Upper Valley Medical Center | Troy, Ohio 45373 |
Harrison Bremerton Hematology and Oncology | Bremerton, Washington 98310 |
Columbia Basin Hematology and Oncology PLLC | Kennewick, Washington 99336 |
Minor and James Medical PLLC | Seattle, Washington 98104 |
The Polyclinic | Seattle, Washington 98122 |
Swedish Medical Center-First Hill | Seattle, Washington 98122-4307 |
Marin General Hospital | Greenbrae, California 94904 |
Sandra L Maxwell Cancer Center | Cedar City, Utah 84720 |
Intermountain Medical Center | Murray, Utah 84157 |
Utah Valley Regional Medical Center | Provo, Utah 84603 |
Dixie Medical Center Regional Cancer Center | Saint George, Utah 84770 |
Intermountain Health Care | Salt Lake City, Utah 84103 |
Utah Cancer Specialists-Salt Lake City | Salt Lake City, Utah 84106 |
Skagit Valley Hospital | Mt. Vernon, Washington 98273 |
United General Hospital | Sedro-Woolley, Washington 98284 |
Southwest Oncology Group | San Antonio, Texas 78245 |
PeaceHealth Saint Joseph Medical Center | Bellingham, Washington 98225 |
NEA Baptist Memorial Hospital | Jonesboro, Arkansas 72401 |