Phase I/Randomized Phase II Trial of Either Dasatinib or Placebo Combined With Standard Chemo-Radiotherapy for Newly Diagnosed Glioblastoma Multiforme (GBM)
OBJECTIVES:
- To establish a maximum-tolerated dose of dasatinib combined with radiation and
temozolomide in patients with newly diagnosed glioblastoma multiforme. (Phase I) (Phase
I study closed to patient accrual on April 29, 2011 and has been completed)
- To determine the efficacy of dasatinib in combination with radiotherapy and concomitant
adjuvant temozolomide, and compare it with the standard of care approach, consisting of
radiotherapy and temozolomide, followed by adjuvant temozolomide in these patients.
(Phase II) (Phase II study opened to patient accrualon August 5, 2011)
- To determine the relationship between tumor biomarkers and clinical outcome of patients
treated with the dasatinib/radiotherapy/temozolomide combination. (Phase II)
- To evaluate potential mechanisms of therapy resistance in recurrent tumor samples
obtained at the time of surgery for recurrent disease.
- To assess the impact of the addition of dasatinib to radiotherapy and temozolomide on
the quality of life (QOL) of these patients, as assessed by FACT-Br, EORTC QLQ-C15-PAL,
and EORTC QLQ-BN20. (Phase II)
- To compare the results of the two most commonly used QOL tools, FACT-Br and EORTC QLQ
C15-PAL plus BN20 and validate the use of EORTC QLQ-C15-PAL plus BN20 in these
patients.(Phase II)
OUTLINE: This is a multicenter, phase I dose-escalation study of dasatinib (Phase I study
closed to patient accrual on April 29, 2011 and has been completed) followed by a randomized
phase II study (Phase II study opened to patient accrual on August 5, 2011).
- Phase I:
- Course 1: Patients receive oral dasatinib once daily and oral temozolomide once
daily on days 1-42. Patients undergo external-beam radiotherapy (EBRT), including
intensity-modulated radiotherapy, 5 days a week for 6 weeks.
- Courses 2-7: Beginning 28-42 days after course 1, patients receive oral dasatinib
once daily on days 1-28 and oral temozolomide once daily on days 1-5. Treatment
repeats every 28 days for 6 courses in the absence of disease progression or
unacceptable toxicity.
- Phase II: Patients are stratified according to age (> 70 years vs ≤ 70 years). Patients
are randomized to 1 of 2 treatment arms.
- Arm I:
- Course 1: Patients receive oral dasatinib once daily and oral temozolomide
once daily on days 1-42. Patients undergo EBRT 5 days a week for 6 weeks.
- Courses 2-7: Beginning 28-42 days after course 1, patients receive oral
dasatinib once daily on days 1-28 and oral temozolomide once daily on days
1-5. Treatment repeats every 28 days for 6 courses in the absence of disease
progression or unacceptable toxicity.
- Arm II:
- Course 1: Patients receive oral placebo once daily on days 1-42 and
temozolomide as in arm I. Patients also undergo EBRT as in arm I.
- Courses 2-7: Beginning 28-42 days after course 1, patients receive oral
placebo once daily on days 1-28 and temozolomide as in arm I. Treatment
repeats every 28 days for 6 courses in the absence of disease progression or
unacceptable toxicity.
Tissue samples are collected for correlative studies.
Quality of life is assessed periodically using the FACT-Br, EORTC QLQ-C15-PAL v.1, and EORTC
BN-20 questionnaires.
After completion of study therapy, patients are followed up every 6 months for 5 years.
Interventional
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Overall survival
No
Nadia N. Laack, MD
Study Chair
Mayo Clinic
Unspecified
CDR0000637854
NCT00869401
June 2009
Name | Location |
---|---|
Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Cedar Rapids Oncology Associates | Cedar Rapids, Iowa 52403 |
Mercy Medical Center - Sioux City | Sioux City, Iowa 51104 |
Siouxland Hematology-Oncology Associates, LLP | Sioux City, Iowa 51101 |
St. Luke's Regional Medical Center | Sioux City, Iowa 51104 |
MeritCare Bemidji | Bemidji, Minnesota 56601 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
CCOP - Duluth | Duluth, Minnesota 55805 |
Miller - Dwan Medical Center | Duluth, Minnesota 55805 |
Fairview Southdale Hospital | Edina, Minnesota 55435 |
Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota 55432 |
Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
HealthEast Cancer Care at St. John's Hospital | Maplewood, Minnesota 55109 |
Hennepin County Medical Center - Minneapolis | Minneapolis, Minnesota 55415 |
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis, Minnesota 55407 |
St. Francis Cancer Center at St. Francis Medical Center | Shakopee, Minnesota 55379 |
Park Nicollet Cancer Center | St. Louis Park, Minnesota 55416 |
Regions Hospital Cancer Care Center | St. Paul, Minnesota 55101 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
MeritCare Broadway | Fargo, North Dakota 58122 |
Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa, Oklahoma 74136 |
Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls, South Dakota 57117-5039 |
Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
Marshfield Clinic - Marshfield Center | Marshfield, Wisconsin 54449 |
Marshfield Clinic - Indianhead Center | Rice Lake, Wisconsin 54868 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
CCOP - Columbus | Columbus, Ohio 43206 |
CCOP - Dayton | Kettering, Ohio 45429 |
CCOP - Greenville | Greenville, South Carolina 29615 |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
Saint Joseph Regional Medical Center | South Bend, Indiana 46617 |
Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
Wesley Medical Center | Wichita, Kansas 67214 |
John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
St. Vincent Mercy Medical Center | Toledo, Ohio 43608 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Mission Hospitals - Memorial Campus | Asheville, North Carolina 28801 |
Medical University of Ohio Cancer Center | Toledo, Ohio 43614 |
Toledo Hospital | Toledo, Ohio 43606 |
CCOP - Hematology-Oncology Associates of Central New York | East Syracuse, New York 13057 |
Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana 59101 |
St. Peter's Hospital | Helena, Montana 59601 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana 59802 |
Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana 59802 |
Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
Adena Regional Medical Center | Chillicothe, Ohio 54601 |
Doctors Hospital at Ohio Health | Columbus, Ohio 43228 |
Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
Grady Memorial Hospital | Delaware, Ohio 43015 |
Fairfield Medical Center | Lancaster, Ohio 43130 |
Strecker Cancer Center at Marietta Memorial Hospital | Marietta, Ohio 45750 |
Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark, Ohio 43055 |
Community Hospital of Springfield and Clark County | Springfield, Ohio 45505 |
Genesis - Good Samaritan Hospital | Zanesville, Ohio 43701 |
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
Gundersen Lutheran Center for Cancer and Blood | La Crosse, Wisconsin 54601 |
Helen and Harry Gray Cancer Center at Hartford Hospital | Hartford, Connecticut 06102-5037 |
Elkhart General Hospital | Elkhart, Indiana 46515 |
Howard Community Hospital | Kokomo, Indiana 46904 |
Lakeland Regional Cancer Care Center - St. Joseph | St. Joseph, Michigan 49085 |
Mount Carmel Health - West Hospital | Columbus, Ohio 43222 |
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | Allentown, Pennsylvania 18105 |
St. Joseph Medical Center | Bloomington, Illinois 61701 |
Eureka Community Hospital | Eureka, Illinois 61530 |
BroMenn Regional Medical Center | Normal, Illinois 61761 |
Community Cancer Center | Normal, Illinois 61761 |
Community Hospital of Ottawa | Ottawa, Illinois 61350 |
Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa, Illinois 61350 |
Cancer Treatment Center at Pekin Hospital | Pekin, Illinois 61554 |
Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria, Illinois 61615 |
OSF St. Francis Medical Center | Peoria, Illinois 61637 |
Proctor Hospital | Peoria, Illinois 61614 |
Illinois Valley Community Hospital | Peru, Illinois 61354 |
Valley Cancer Center | Spring Valley, Illinois 61362 |
Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana 46350 |
Mercy Regional Cancer Center at Mercy Medical Center | Cedar Rapids, Iowa 52403 |
John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines, Iowa 50309 |
Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines, Iowa 50314 |
Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Medical Oncology and Hematology Associates - West Des Moines | West Des Moines, Iowa 50266 |
Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
Hickman Cancer Center at Bixby Medical Center | Adrian, Michigan 49221 |
Community Cancer Center of Monroe | Monroe, Michigan 48162 |
Coborn Cancer Center | Saint Cloud, Minnesota 56303 |
CentraCare Clinic - River Campus | St. Cloud, Minnesota 56303 |
Wood County Oncology Center | Bowling Green, Ohio 43402 |
Samaritan North Cancer Care Center | Dayton, Ohio 45415 |
Grandview Hospital | Dayton, Ohio 45405 |
David L. Rike Cancer Center at Miami Valley Hospital | Dayton, Ohio 45409 |
Good Samaritan Hospital | Dayton, Ohio 45406 |
Blanchard Valley Medical Associates | Findlay, Ohio 45840 |
Charles F. Kettering Memorial Hospital | Kettering, Ohio 45429 |
Lima Memorial Hospital | Lima, Ohio 45804 |
Northwest Ohio Oncology Center | Maumee, Ohio 43537 |
Middletown Regional Hospital | Middletown, Ohio 45044 |
Toledo Clinic - Oregon | Oregon, Ohio 43616 |
St. Charles Mercy Hospital | Oregon, Ohio 43616 |
Mercy Hospital of Tiffin | Tiffin, Ohio 44883 |
Toledo Clinic, Incorporated - Main Clinic | Toledo, Ohio 43623 |
UVMC Cancer Care Center at Upper Valley Medical Center | Troy, Ohio 45373-1300 |
Fulton County Health Center | Wauseon, Ohio 43567 |
Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia, Ohio 45385 |
Altru Cancer Center at Altru Hospital | Grand Forks, North Dakota 58201 |
John B. Amos Cancer Center | Columbus, Georgia 31904 |
Michiana Hematology-Oncology, PC - Elkhart | Elkhart, Indiana 46514 |
Elkhart Clinic, LLC | Elkhart, Indiana 46514-2098 |
Michiana Hematology Oncology PC - La Porte | La Porte, Indiana 46350 |
Michiana Hematology-Oncology, PC - South Bend | Mishawaka, Indiana 46545-1470 |
Michiana Hematology Oncology PC - Plymouth | Plymouth, Indiana 46563 |
Reid Hospital & Health Care Services | Richmond, Indiana 47374 |
Cancer Center of Kansas, PA - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas, PA - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas - Fort Scott | Fort Scott, Kansas 66701 |
Cancer Center of Kansas-Independence | Independence, Kansas 67301 |
Cancer Center of Kansas, PA - Kingman | Kingman, Kansas 67068 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Cancer Center of Kansas, PA - Liberal | Liberal, Kansas 67905 |
Cancer Center of Kansas, PA - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas, PA - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas, PA - Pratt | Pratt, Kansas 67124 |
Cancer Center of Kansas, PA - Salina | Salina, Kansas 67401 |
Cancer Center of Kansas, PA - Wellington | Wellington, Kansas 67152 |
Cancer Center of Kansas, PA - Wichita | Wichita, Kansas 67214 |
Associates in Womens Health, PA - North Review | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Winfield | Winfield, Kansas 67156 |
Mercy Memorial Hospital - Monroe | Monroe, Michigan 48162 |
Lakeside Cancer Specialists, PLLC | Saint Joseph, Michigan 49085 |
Willmar Cancer Center at Rice Memorial Hospital | Willmar, Minnesota 56201 |
Billings Clinic - Downtown | Billings, Montana 59107-7000 |
Bozeman Deaconess Cancer Center | Bozeman, Montana 59715 |
St. James Healthcare Cancer Care | Butte, Montana 59701 |
Grant Medical Center Cancer Care | Columbus, Ohio 43215 |
Hematology Oncology Center | Elyria, Ohio 44035 |
Community Cancer Center | Elyria, Ohio 44035 |
Wayne Hospital | Greenville, Ohio 45331 |
Knox Community Hospital | Mount Vernon, Ohio 43050 |
Flower Hospital Cancer Center | Sylvania, Ohio 43560 |
St. Anne Mercy Hospital | Toledo, Ohio 43623 |
Mount Carmel St. Ann's Cancer Center | Westerville, Ohio 43081 |
Fredericksburg Oncology, Incorporated | Fredericksburg, Virginia 22401 |
Center for Cancer Treatment & Prevention at Sacred Heart Hospital | Eau Claire, Wisconsin 54701 |
Marshfield Clinic Cancer Care at Regional Cancer Center | Eau Claire, Wisconsin 54701 |
Saint Joseph's Hospital | Marshfield, Wisconsin 54449 |
Marshfield Clinic - Lakeland Center | Minocqua, Wisconsin 54548 |
Ministry Medical Group at Saint Mary's Hospital | Rhinelander, Wisconsin 54501 |
Marshfield Clinic at Saint Michael's Hospital | Stevens Point, Wisconsin 54481 |
Saint Michael's Hospital Cancer Center | Stevens Point, Wisconsin 54481 |
Marshfield Clinic - Weston Center | Weston, Wisconsin 54476 |
Mid Dakota Clinic, PC | Bismarck, North Dakota 58501 |
Greenville Hospital Cancer Center | Greenville, South Carolina 29605 |
Cancer Centers of the Carolinas - Grove Commons | Greenville, South Carolina 29605 |
Cancer Centers of the Carolinas - Faris Road | Greenville, South Carolina 29605 |
Cancer Centers of the Carolinas - Greer Medical Oncology | Greer, South Carolina 29650 |
Cancer Centers of the Carolinas - Seneca | Seneca, South Carolina 29672 |
Cancer Centers of the Carolinas - Spartanburg | Spartanburg, South Carolina 29307 |
Resurrection Medical Center | Chicago, Illinois 60631 |
Cancer Centers of the Carolinas - Eastside | Greenville, South Carolina 29601 |
Lakes Region General Hospital | Laconia, New Hampshire 03246 |
Galesburg Clinic, PC | Galesburg, Illinois 61401 |
St. Vincent Healthcare Cancer Care Services | Billings, Montana 59101 |
Illinois CancerCare - Bloomington | Bloomington%, Illinois 61701 |
Illinois CancerCare - Canton | Canton, Illinois 61520 |
Illinois CancerCare - Carthage | Carthage, Illinois 62321 |
Illinois CancerCare - Eureka | Eureka, Illinois 61530 |
Illinois CancerCare - Havana | Havana, Illinois 62644 |
Illinois CancerCare - Kewanee Clinic | Kewanee, Illinois 61443 |
Illinois CancerCare - Macomb | Macomb, Illinois 61455 |
OSF Holy Family Medical Center | Monmouth, Illinois 61462 |
Illinois CancerCare - Monmouth | Monmouth, Illinois 61462 |
Illinois CancerCare - Community Cancer Center | Normal, Illinois 61761 |
Illinois CancerCare - Pekin | Pekin, Illinois 61603 |
Illinois CancerCare - Peru | Peru, Illinois 61354 |
Illinois CancerCare - Princeton | Princeton, Illinois 61356 |
Illinois CancerCare - Spring Valley | Spring Valley, Illinois 61362 |
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care | Concord, New Hampshire 03301 |
New Hampshire Oncology - Hematology, PA - Hooksett | Hooksett, New Hampshire 03106 |
Medcenter One Hospital Cancer Care Center | Bismarck, North Dakota 58501 |
St. Alexius Medical Center Cancer Center | Bismarck, North Dakota 58502 |
Precision Radiotherapy at University Pointe | West Chester, Ohio 45069 |
Cancer Centers of the Carolinas - Easley | Easley, South Carolina 29640 |
Cancer Centers of the Carolinas - Greer Radiation Oncology | Greer, South Carolina 29650 |
Minnesota Oncology - Maplewood | Maplewood, Minnesota 55109 |
Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale, Minnesota 55422-2900 |
Lakeview Hospital | Stillwater, Minnesota 55082 |
Minnesota Oncology - Woodbury | Woodbury, Minnesota 55125 |
Central Wisconsin Cancer Program at Agnesian HealthCare | Fond du Lac, Wisconsin 54935 |
Southern Ohio Medical Center Cancer Center | Portsmouth, Ohio 45662 |
St. Francis Hospital Cancer Care Services | Indianapolis, Indiana 46237 |
Mercy Cancer Center - West Lakes | Clive, Iowa 50325 |
Methodist West Hospital | West Des Moines, Iowa 50266-7700 |
Benefis Sletten Cancer Institute | Great Falls, Montana 59405 |
Essentia Health - Duluth Clinic | Duluth, Minnesota 55805-1983 |