Phase II Trial of Dasatinib in Patients With Recurrent Glioblastoma Multiforme
PRIMARY OBJECTIVES:
I. Determine the therapeutic efficacy of dasatinib, in terms of 6-month progression-free
survival, in all patients (i.e., stage 1B [closed to accrual as of 4/14/2009] and stage 2
[closed to accrual as of 4/14/2009] combined) with recurrent/progressive glioblastoma
multiforme or gliosarcoma.
SECONDARY OBJECTIVES:
I. Determine the therapeutic efficacy of this drug, in terms of a hybrid endpoint of 6-month
progression-free survival or objective response (complete or partial) rate, in patients in
stage 1B (closed to accrual as of 4/14/2009).
II. Determine overall survival of patients treated with this regimen. III. Determine the
toxicity of this regimen in these patients. IV. Determine radiographic response rate in
patients treated with this regimen. V. Determine progression-free survival of patients
treated with this regimen. VI. Explore molecular correlates of clinical outcome in patients
treated with this regimen.
VII. Explore pharmacokinetic correlates of dosing, toxicity, and efficacy.
OUTLINE: This a multicenter study.
Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity.
After the completion of study treatment, patients are followed periodically.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival
6 months
No
Andrew Lassman
Principal Investigator
American College of Radiology Imaging Network
United States: Food and Drug Administration
NCI-2009-00744
NCT00423735
January 2007
Name | Location |
---|---|
Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
Hurley Medical Center | Flint, Michigan 48503 |
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 |
Akron General Medical Center | Akron, Ohio 44302 |
Delaware County Memorial Hospital | Drexel Hill, Pennsylvania 19026 |
York Hospital | York, Pennsylvania 17315 |
University of Texas Medical Branch | Galveston, Texas 77555-1329 |
LDS Hospital | Salt Lake City, Utah 84143 |
Boston Medical Center | Boston, Massachusetts 02118 |
Bay Medical Center | Panama City, Florida 32401 |
University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma 73104 |
Mobile Infirmary Medical Center | Mobile, Alabama 36640-0460 |
University of Wisconsin Hospital and Clinics | Madison, Wisconsin 53792-0001 |
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 |
Beebe Medical Center | Lewes, Delaware 19958 |
Mercy Hospital | Coon Rapids, Minnesota 55433 |
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 |
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 |
Saint Luke's East - Lee's Summit | Lee's Summit, Missouri 64086 |
Liberty Hospital | Liberty, Missouri 64068 |
Heartland Regional Medical Center | Saint Joseph, Missouri 64506 |
Singing River Hospital | Pascagoula, Mississippi 39581 |
Union Hospital of Cecil County | Elkton MD, Maryland 21921 |
Solano Radiation Oncology Center | Vacaville, California 95687 |
Independence Regional Health Center | Independence, Missouri 64050 |
Hennepin County Medical Center | Minneapolis, Minnesota |
University of Florida | Gainesville, Florida 32610-0277 |
University of Rochester | Rochester, New York 14642 |
University of Arizona Health Sciences Center | Tucson, Arizona 85724 |
Dartmouth Hitchcock Medical Center | Lebanon, New Hampshire 03756 |
University Of Vermont | Burlington,, Vermont 05403 |
Huntsman Cancer Institute/University of Utah | Salt Lake City, Utah 84112 |
Metro-Minnesota CCOP | St. Louis Park, Minnesota |
UC Davis Comprehensive Cancer Center | Sacramento, California 95817 |
Memorial Health University Medical Center | Savannah, Georgia 31404 |
M D Anderson Cancer Center | Houston, Texas 77030 |
University of Cincinnati | Cincinnati, Ohio 45267-0502 |
Penn State Milton S Hershey Medical Center | Hershey, Pennsylvania 17033 |
Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
John B Amos Cancer Center | Columbus, Georgia 31904 |
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 |
Green Bay Oncology - Escanaba | Escanaba, Michigan 49431 |
Green Bay Oncology - Iron Mountain | Iron Mountain, Michigan 49801 |
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 |
Truman Medical Center | Kansas City, Missouri 64108 |
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield | Springfield, Missouri 65802 |
Cox Medical Center | Springfield, Missouri 65807 |
Cheshire Medical Center-Dartmouth-Hitchcock Keene | Keene, New Hampshire 03431 |
Cooper Hospital University Medical Center | Camden, New Jersey 08103 |
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County | Mount Holly, New Jersey 08060 |
Sparta Cancer Treatment Center | Sparta, New Jersey 07871 |
Virtua West Jersey Hospital Voorhees | Voorhees, New Jersey 08043 |
Highland Hospital | Rochester, New York 14620 |
Aultman Health Foundation | Canton, Ohio 44710 |
Samaritan North Health Center | Dayton, Ohio 45415 |
Salem Hospital | Salem, Oregon 97309 |
Wheeling Hospital | Wheeling, West Virginia 26003 |
Saint Vincent Hospital | Green Bay, Wisconsin 54301 |
Green Bay Oncology Limited at Saint Mary's Hospital | Green Bay, Wisconsin 54303 |
Saint Mary's Hospital | Green Bay, Wisconsin 54303 |
Green Bay Oncology at Saint Vincent Hospital | Green Bay, Wisconsin 54301-3526 |
Bay Area Medical Center | Marinette, Wisconsin 54143 |
Green Bay Oncology - Oconto Falls | Oconto Falls, Wisconsin 54154 |
Green Bay Oncology - Sturgeon Bay | Sturgeon Bay, Wisconsin 54235 |
Northeast Radiation Oncology Center | Dunmore, Pennsylvania 18512 |
Radiological Associates of Sacramento | Sacramento, California 95816 |
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 |
Upper Delaware Valley Cancer Center | Milford, Pennsylvania 18337 |
Thompson Cancer Survival Center at Methodist | Oak Ridge, Tennessee 37830 |
Adams Cancer Center | Gettysburg, Pennsylvania 17325 |
Cherry Tree Cancer Center | Hanover, Pennsylvania 17331 |
Saint Luke's South Hospital | Overland Park, Kansas 66213 |
Heartland Hematology and Oncology Associates Incorporated | Kansas City, Missouri 64118 |
Saint Francis Hospital | Greenville, South Carolina 29601 |
Gundersen Lutheran | La Crosse, Wisconsin 54601 |
University Pointe | West Chester, Ohio 45069 |
Genesys Regional Medical Center-West Flint Campus | Flint, Michigan 48532 |
Christiana Care Health System-Christiana Hospital | Newark, Delaware 19718 |
IU Health Methodist Hospital | Indianapolis, Indiana 46202 |
Fletcher Allen Health Care-Medical Center | Burlington, Vermont 05401 |
Auburn Radiation Oncology Center | Auburn, California 95603 |
Marshall Radiation Oncology Center | Cameron Park, California 95682 |
Mercy San Juan Medical Center | Carmichael, California 95608 |
Roseville Radiation Oncology Center | Roseville, California 95661 |
Mercy General Hospital Radiation Oncology Center | Sacramento, California 95819 |
Norris Cotton Cancer Center-North | Saint Johnsbury, Vermont 05819 |
Covenant Medical Center-Lakeside | Lubbock, Texas 79410 |
Cape Radiation Oncology | Cape Girardeau, Missouri 63703 |
Innovative Cancer Research Consortium | Glendale, California 91206 |
Thompson Cancer Survival Center - West | Knoxville, Tennessee 37392 |