Phase II Trial of the Aurora Kinase A Inhibitor MLN8237, in Relapsed or Refractory Peripheral T-Cell Non-Hodgkin Lymphoma
OBJECTIVES:
I. To estimate the objective response rate (complete responses [CR] + partial responses
[PR]) after 4 courses of treatment with alisertib (MLN8237) in patients with relapsed or
refractory peripheral T-cell non-Hodgkin lymphoma.
II. To assess overall survival (OS) and progression-free survival (PFS) in this patient
population.
III. To evaluate the safety and tolerability of MLN8237 treatment for this patient
population.
IV. To explore the association between pre-treatment aurora kinase A expression in tumor
biopsies as measured by fluorescence in situ hybridization (FISH) and objective response
rate in patients with peripheral T-cell lymphomas (PTCL) treated with MLN8237. (exploratory)
IV. To investigate the copy number, mutational status, expression of aurora kinase (A, B,
and C) and associated signaling pathways in PTCL utilizing tissue microarray analysis (TMA)
before and after treatment with MLN8237.
EXPLORATORY OBJECTIVES:
I. To investigate changes in the serum cytokine profile pre- and post- aurora kinase
Inhibitor treatment.
II. To evaluate serum markers of apoptosis pre- and post- aurora kinase inhibitor treatment
as pharmacodynamic markers of efficacy.
OUTLINE:
Patients receive alisertib orally (PO) twice daily (BID) on days 1-7. Treatment repeats
every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 4 months for 2 years.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate (CR and PR)
Up to 2 years
No
Paul Barr
Principal Investigator
Southwest Oncology Group
United States: Food and Drug Administration
NCI-2011-03551
NCT01466881
October 2011
Name | Location |
---|---|
Louisiana State University | New Orleans, Louisiana 70112-2282 |
Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Hurley Medical Center | Flint, Michigan 48503 |
University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
Loyola University Medical Center | Maywood, Illinois 60153 |
Sutter Health Western Division Cancer Research Group | Greenbrae, California 94904 |
Lehigh Valley Hospital | Allentown, Pennsylvania 18103 |
Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Weill Medical College of Cornell University | New York, New York 10021 |
University of Wisconsin Hospital and Clinics | Madison, Wisconsin 53792-0001 |
Great Falls Clinic | Great Falls, Montana 59405 |
Cancer Center of Kansas - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas - Dodge City | Dodge City, Kansas 67801 |
Cancer Center of Kansas - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas - Salina | Salina, Kansas 67042 |
Cancer Center of Kansas - Wellington | Wellington, Kansas 67152 |
Associates in Womens Health | Wichita, Kansas 67203 |
Cancer Center of Kansas - Winfield | Winfield, Kansas 67156 |
Bozeman Deaconess Hospital | Bozeman, Montana 59715 |
Big Sky Oncology | Great Falls, Montana 59405 |
Kalispell Medical Oncology | Kalispell, Montana 59901 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Welch Cancer Center | Sheridan, Wyoming 82801 |
City of Hope Medical Center | Duarte, California 91010 |
Sutter Solano Medical Center | Vallejo, California 94589 |
Beebe Medical Center | Lewes, Delaware 19958 |
Hematology and Oncology Associates | Chicago, Illinois 60611 |
Iredell Memorial Hospital | Statesville, North Carolina 28677 |
Bismarck Cancer Center | Bismarck, North Dakota 58501 |
Mercy Hospital | Coon Rapids, Minnesota 55433 |
Hematology Oncology Associates of Illinois-Highland Park | Highland Park, Illinois 60035 |
Ottumwa Regional Health Center | Ottumwa, Iowa 52501 |
Saint Joseph Mercy Hospital | Ann Arbor, Michigan 48106 |
Fairview-Southdale Hospital | Edina, Minnesota 55435 |
Abbott-Northwestern Hospital | Minneapolis, Minnesota 55407 |
Regions Hospital | Saint Paul, Minnesota 55101 |
Saint Francis Regional Medical Center | Shakopee, Minnesota 55379 |
Rice Memorial Hospital | Willmar, Minnesota 56201 |
Cancer Center of Kansas - Fort Scott | Fort Scott, Kansas 66701 |
Cancer Center of Kansas-Independence | Independence, Kansas 67301 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Menorah Medical Center | Overland Park, Kansas 66209 |
North Kansas City Hospital | Kansas City, Missouri 64116 |
Research Medical Center | Kansas City, Missouri 64132 |
Saint Luke's East - Lee's Summit | Lee's Summit, Missouri 64086 |
Heartland Regional Medical Center | Saint Joseph, Missouri 64506 |
Bozeman Deaconess Cancer Center | Bozeman, Montana 59715 |
Northern Montana Hospital | Havre, Montana 59501 |
Rocky Mountain Oncology | Casper, Wyoming 82609 |
Union Hospital of Cecil County | Elkton MD, Maryland 21921 |
Queen's Medical Center | Honolulu, Hawaii 96813 |
Providence Hospital | Mobile, Alabama 36608 |
Northwestern University | Chicago, Illinois 60611 |
Kapiolani Medical Center at Pali Momi | Aiea, Hawaii 96701 |
Kapiolani Medical Center for Women and Children | Honolulu, Hawaii 96826 |
Hennepin County Medical Center | Minneapolis, Minnesota |
Saint Louis University Hospital | St. Louis, Missouri 63110-0250 |
University of Rochester | Rochester, New York 14642 |
Saint Alphonsus Regional Medical Center | Boise, Idaho 83706 |
Emory University | Atlanta, Georgia 30322 |
University of Arizona Health Sciences Center | Tucson, Arizona 85724 |
Straub Clinic and Hospital | Honolulu, Hawaii 96813 |
University of Massachusetts Medical School | Worcester, Massachusetts 01605 |
Cancer Center of Kansas - McPherson | McPherson, Kansas 67460 |
California Pacific Medical Center | San Francisco, California 94115 |
Mid Dakota Clinic | Bismarck, North Dakota 58501 |
Wichita CCOP | Wichita, Kansas 67214-3882 |
Montana Cancer Consortium CCOP | Billings, Montana 59101 |
Metro-Minnesota CCOP | St. Louis Park, Minnesota |
Lakeview Hospital | Stillwater, Minnesota 55082 |
Tulane University Health Sciences Center | New Orleans, Louisiana 70112 |
Montana Cancer Specialists | Missoula, Montana 59807-7877 |
University of Cincinnati | Cincinnati, Ohio 45267-0502 |
Castle Medical Center | Kailua, Hawaii 96734 |
New Ulm Medical Center | New Ulm, Minnesota 56073 |
Mills - Peninsula Hospitals | Burlingame, California 94010 |
Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
Lombardi Comprehensive Cancer Center at Georgetown University | Washington, District of Columbia 20057 |
Oncare Hawaii Inc-POB II | Honolulu, Hawaii 96813 |
Oncare Hawaii Inc-Kuakini | Honolulu, Hawaii 96817 |
University of Hawaii | Honolulu, Hawaii 96813 |
Provena Saint Mary's Hospital | Kankakee, Illinois 60901 |
North Shore Hematology Oncology | Libertyville, Illinois 60048 |
Hematology Oncology Associates of Illinois - Skokie | Skokie, Illinois 60076 |
McFarland Clinic | Ames, Iowa 50010 |
Cancer Center of Kansas - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas-Kingman | Kingman, Kansas 67068 |
Cancer Center of Kansas - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas - Pratt | Pratt, Kansas 67124 |
Cancer Center of Kansas-Wichita Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas - Main Office | Wichita, Kansas 67214 |
Michigan Cancer Research Consortium Community Clinical Oncology Program | Ann Arbor, Michigan 48106 |
Oakwood Hospital | Dearborn, Michigan 48123 |
Saint John Hospital and Medical Center | Detroit, Michigan 48236 |
Allegiance Health | Jackson, Michigan 49201 |
Sparrow Hospital | Lansing, Michigan 48912 |
Saint Mary Mercy Hospital | Livonia, Michigan 48154 |
Saint Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
Saint Joseph Mercy Port Huron | Port Huron, Michigan 48060 |
Saint Mary's of Michigan | Saginaw, Michigan 48601 |
Saint John Macomb-Oakland Hospital | Warren, Michigan 48093 |
Unity Hospital | Fridley, Minnesota 55432 |
Saint John's Hospital - Healtheast | Maplewood, Minnesota 55109 |
Minnesota Oncology Hematology PA-Maplewood | Maplewood, Minnesota 55109 |
North Memorial Medical Health Center | Robbinsdale, Minnesota 55422 |
Park Nicollet Clinic - Saint Louis Park | Saint Louis Park, Minnesota 55416 |
Minnesota Oncology and Hematology PA-Woodbury | Woodbury, Minnesota 55125 |
Saint Luke's Cancer Institute | Kansas City, Missouri 64111 |
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 |
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield | Springfield, Missouri 65802 |
Saint John's Hospital | Springfield, Missouri 65804 |
Cox Medical Center | Springfield, Missouri 65807 |
Hematology-Oncology Centers of the Northern Rockies PC | Billings, Montana 59101 |
Saint Vincent Healthcare | Billings, Montana 59101 |
Billings Clinic | Billings, Montana 59107-7000 |
Saint James Community Hospital and Cancer Treatment Center | Butte, Montana 59701 |
Benefis Healthcare- Sletten Cancer Institute | Great Falls, Montana 59405 |
Saint Peter's Community Hospital | Helena, Montana 59601 |
Glacier Oncology PLLC | Kalispell, Montana 59901 |
Saint Patrick Hospital - Community Hospital | Missoula, Montana 59802 |
Cooper Hospital University Medical Center | Camden, New Jersey 08103 |
New York University Langone Medical Center | New York, New York 10016 |
Saint Alexius Medical Center | Bismarck, North Dakota 58501 |
Salem Hospital | Salem, Oregon 97309 |
Audie L Murphy Veterans Affairs Hospital | San Antonio, Texas 78209 |
University Hospital | San Antonio, Texas 78229 |
Cancer Center of Kansas-Liberal | Liberal, Kansas 67901 |
Roper Hospital | Charleston, South Carolina 29401 |
Arizona Cancer Center at University Medical Center North | Tucson, Arizona 85719 |
Kuakini Medical Center | Honolulu, Hawaii 96817 |
Arizona Cancer Center at UMC Orange Grove | Tucson, Arizona 85704 |
Wilcox Memorial Hospital and Kauai Medical Clinic | Lihue, Hawaii 96766-1099 |
Saint Luke's South Hospital | Overland Park, Kansas 66213 |
Kansas City CCOP | Prairie Village, Kansas 66208 |
Hematology and Oncology Clinic | Baton Rouge, Louisiana 70809 |
Heartland Hematology and Oncology Associates Incorporated | Kansas City, Missouri 64118 |
Saint Joseph Oncology Inc | Saint Joseph, Missouri 64507 |
Alta Bates Summit Medical Center-Herrick Campus | Berkeley, California 94704 |
Southwest Oncology Group | San Antonio, Texas 78245 |
Southwest Oncology Group (SWOG) Research Base | San Antonio, Texas 78245 |
Genesys Regional Medical Center-West Flint Campus | Flint, Michigan 48532 |
Sanford Bismarck Medical Center | Bismarck, North Dakota 58501 |
Christiana Care Health System-Christiana Hospital | Newark, Delaware 19718 |
Illinois Cancer Specialists-Niles | Niles, Illinois 60714 |
Sutter Pacific Medical Foundation | Santa Rosa, California 95403 |
OnCare Hawaii-Liliha | Honolulu, Hawaii 96817-3169 |
Oncare Hawaii Inc - Kapiolani Medical Center at Pali Momi | Aiea, Hawaii 96701 |