A Phase III Study of Radiation Therapy (RT) and O6-Benzylguanine (O6-BG) Plus BCNU Versus RT and BCNU Alone for Newly Diagnosed Glioblastoma Multiforme (GBM) and Gliosarcoma
OBJECTIVES:
- Compare the overall survival, failure-free survival, and progression-free survival of
patients with newly diagnosed glioblastoma multiforme or gliosarcoma treated with
radiotherapy and carmustine with or without O6-benzylguanine.
- Compare the frequency and severity of toxic effects of these regimens in these
patients.
- Correlate the survival of these patients with the expression of O6-alkylguanine-DNA
alkyltransferase.
OUTLINE: This is a randomized study. Patients are stratified according to age (under 50 vs
50 and over), prior surgery (biopsy only vs resection), and Zubrod performance status (0-1
vs 2). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo radiotherapy daily 5 days a week over 7 weeks for a total of 34
fractions. Patients also receive chemotherapy comprising O6-benzylguanine IV over 1
hour followed 6 hours later by carmustine IV over 1 hour on day 1 of radiotherapy.
Chemotherapy repeats every 6 weeks for a maximum of 7 courses in the absence of disease
progression or unacceptable toxicity.
- Arm II: Patients undergo radiotherapy as in arm I. Patients receive carmustine IV as in
arm I.
Patients are followed at week 48, every 4 months for 1 year, and then every 6 months for 4
years.
PROJECTED ACCRUAL: A total of 375 patients will be accrued for this study within 5 years.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Survival
assessed every 6 weeks for 42 weeks, then every 4 months for one year, followed by every 6 months for years 2 through 5
No
Deborah T. Blumenthal, MD
Study Chair
University of Utah
United States: Federal Government
CDR0000068656
NCT00017147
September 2001
November 2012
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
CCOP - Atlanta Regional | Atlanta, Georgia 30342-1701 |
CCOP - Kansas City | Kansas City, Missouri 64131 |
St. Joseph's Hospital and Medical Center | Phoenix, Arizona 85001-2071 |
Memorial Hospital Cancer Center | Colorado Springs, Colorado 80909 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
CCOP - Columbus | Columbus, Ohio 43206 |
Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
CCOP - Dayton | Kettering, Ohio 45429 |
CCOP - Western Regional, Arizona | Phoenix, Arizona 85006-2726 |
University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver, Colorado 80010 |
CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
CCOP - Scott and White Hospital | Temple, Texas 76508 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
CCOP - St. Louis-Cape Girardeau | Saint Louis, Missouri 63141 |
Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
CCOP - Northwest | Tacoma, Washington 98405-0986 |
Wesley Medical Center | Wichita, Kansas 67214 |
Great Falls Clinic | Great Falls, Montana 59405 |
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington 98104 |
Northside Hospital Cancer Center | Atlanta, Georgia 30342-1611 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
St. John's Regional Health Center | Springfield, Missouri 65804 |
Wilford Hall Medical Center | Lackland Air Force Base, Texas 78236-5300 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Spectrum Health Cancer Care - Butterworth Campus | Grand Rapids, Michigan 49503-2560 |
Presbyterian Cancer Center at Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
Alaska Regional Hospital Cancer Center | Anchorage, Alaska 99508 |
Banner Good Samaritan Medical Center | Phoenix, Arizona 85006 |
Banner Thunderbird Medical Center | Phoenix, Arizona 85306 |
North Colorado Medical Center | Greeley, Colorado 80631 |
McKee Medical Center | Loveland, Colorado 80539 |
Saint Anthony's Hospital at Saint Anthony's Health Center | Alton, Illinois 62002 |
Good Samaritan Regional Health Center | Mt. Vernon, Illinois 62864 |
Cancer Center of Kansas - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas - Dodge City | Dodge City, Kansas 67801 |
Cancer Center of Kansas, P.A. - El Dorado | El Dorado, Kansas 67042 |
Veterans Affairs Medical Center - Kansas City | Kansas City, Kansas 64128 |
Cancer Center of Kansas - Kingman | Kingman, Kansas 67068 |
Southwest Medical Center | Liberal, Kansas 67901 |
Cancer Center of Kansas - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas, P.A. - Parsons | Parsons, Kansas 67357 |
Pratt Cancer Center of Kansas | Pratt, Kansas 67124 |
Cancer Center of Kansas - Salina | Salina, Kansas 67042 |
Cancer Center of Kansas - Wellington | Wellington, Kansas 67152 |
Cancer Center of Kansas, P.A. | Wichita, Kansas 67208 |
Associates in Womens Health | Wichita, Kansas 67203 |
Cancer Center of Kansas, P.A. - Wichita | Wichita, Kansas 67214 |
Cancer Center of Kansas - Winfield | Winfield, Kansas 67156 |
Battle Creek Health System Cancer Care Center | Battle Creek, Michigan 49017 |
Mecosta County General Hospital | Big Rapids, Michigan 49307 |
Metropolitan Hospital | Grand Rapids, Michigan 49506 |
Lacks Cancer Center at Saint Mary's Mercy Medical Center | Grand Rapids, Michigan 49503 |
Holland Community Hospital | Holland, Michigan 49423 |
Hackley Hospital | Muskegon, Michigan 49443 |
Northern Michigan Hospital | Petoskey, Michigan 49770 |
William Beaumont Hospital - Royal Oak Campus | Royal Oak, Michigan 48073 |
Munson Medical Center | Traverse City, Michigan 49684 |
St. Francis Medical Center | Cape Girardeau, Missouri 63701 |
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital | Gape Girardeau, Missouri 63701 |
David C. Pratt Cancer Center at St. John's Mercy | St. Louis, Missouri 63141 |
Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana 59101 |
St. Vincent Healthcare | Billings, Montana 59101 |
Deaconess Billings Clinic - Downtown | Billings, Montana 59101 |
Deaconess Billings Clinic Cancer Center | Billings, Montana 59107 |
Internal Medicine Associates of Bozeman | Bozeman, Montana 59715 |
Bozeman Deaconess Hospital | Bozeman, Montana 59715 |
St. James Community Hospital | Butte, Montana 59701 |
Sletten Regional Cancer Institute | Great Falls, Montana 59405 |
St. Peter's Hospital | Helena, Montana 59601 |
Kalispell Medical Oncology | Kalispell, Montana 59901 |
Glacier Oncology, PLLC | Kalispell, Montana 59901 |
Eastern Montana Cancer Center | Miles City, Montana 59301 |
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana 59802 |
Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana 59802 |
Community Medical Center | Missoula, Montana 59801 |
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 |
Grant Riverside Cancer Services | Columbus, Ohio 43215 |
Mount Carmel West Hospital | Columbus, Ohio 43222 |
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 |
Mercy Medical Center Oncology Unit | Springfield, Ohio 45504 |
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital | Westerville, Ohio 43081 |
Genesis - Good Samaritan Hospital | Zanesville, Ohio 43701 |
St. Joseph Hospital Community Cancer Center | Bellingham, Washington 98225 |
Olympic Hematology and Oncology | Bremerton, Washington 98310 |
Skagit Valley Hospital Cancer Care Center | Mt. Vernon, Washington 98273 |
University Cancer Center at University of Washington Medical Center | Seattle, Washington 98195 |
Harborview Medical Center | Seattle, Washington 98104 |
Group Health Central Hospital | Seattle, Washington 98104 |
North Puget Oncology at United General Hospital | Sedro-Wooley, Washington 98284 |
Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
Central Washington Hospital | Wenatchee, Washington 98801 |
Wenatchee Valley Clinic | Wenatchee, Washington 98801 |
Welch Cancer Center | Sheridan, Wyoming 82801 |
University of Illinois at Chicago Cancer Center | Chicago, Illinois 60612 |
Huntsman Cancer Institute at University of Utah | Salt Lake City, Utah 84112 |
Decatur Memorial Hospital Cancer Care Institute | Decatur, Illinois 62526 |
Veterans Affairs Medical Center - Chicago Westside Hospital | Chicago, Illinois 60612 |
North Bay Cancer Center | Fairfield, California 94533 |
Saint Joseph's Hospital of Atlanta | Atlanta, Georgia 30342-1701 |
Piedmont Hospital | Atlanta, Georgia 30309 |
WellStar Cobb Hospital | Austell, Georgia 30106 |
Charles B. Eberhart Cancer Center at DeKalb Medical Center | Decatur, Georgia 30033 |
Gwinnett Medical Center | Lawrenceville, Georgia 30045 |
Kennestone Cancer Center at Wellstar Kennestone Hospital | Marietta, Georgia 30060 |
Southern Regional Medical Center | Riverdale, Georgia 30274-2600 |
Genesis Medical Center - West Campus | Davenport, Iowa 52804 |
Genesis Regional Cancer Center at Genesis Medical Center | Davenport, Iowa 52803 |
Salina Regional Health Center | Salina, Kansas 67401 |
Stormont-Vail Cancer Center | Topeka, Kansas 66604 |
St. Francis Comprehensive Cancer Center | Topeka, Kansas 66606 |
Mary Bird Perkins Cancer Center - Baton Rouge | Baton Rouge, Louisiana 70809 |
Medical Center of Louisiana - New Orleans | New Orleans, Louisiana 70112 |
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 |
Charles F. Kettering Memorial Hospital | Kettering, Ohio 45429 |
Middletown Regional Hospital | Middletown, Ohio 45044 |
UVMC Cancer Care Center at Upper Valley Medical Center | Troy, Ohio 45373-1300 |
Cleveland Clinic - Wooster | Wooster, Ohio 44691 |
Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia, Ohio 45385 |
Legacy Mount Hood Medical Center | Gresham, Oregon 97030 |
Providence Milwaukie Hospital | Milwaukie, Oregon 97222 |
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center | Portland, Oregon 97210 |
Providence Cancer Center at Providence Portland Medical Center | Portland, Oregon 97213-2967 |
Providence St. Vincent Medical Center | Portland, Oregon 97225 |
Legacy Meridian Park Hospital | Tualatin, Oregon 97062 |
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center | Kingsport, Tennessee 37662 |
Danville Regional Medical Center | Danville, Virginia 24541 |
Southwest Washington Medical Center Cancer Center | Vancouver, Washington 98668 |
St. Anthony Central Hospital | Denver, Colorado 80204-1335 |
St. Anthony North Hospital | Westminster, Colorado 80030 |
Exempla Lutheran Medical Center | Wheat Ridge, Colorado 80033 |
Baton Rouge General Regional Cancer Center | Baton Rouge, Louisiana 70821 |
Community Oncology Group - Independence | Independence, Ohio 44131 |
St. Francis Hospital | Federal Way, Washington 98003 |
St. Clare Hospital | Lakewood, Washington 98499-0998 |
Capital Medical Center | Olympia, Washington 98502 |
Allenmore Hospital | Tacoma, Washington 98411-0414 |
Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
St. Francis Hospital and Health Centers | Beech Grove, Indiana 46107 |
Institute of Oncology at Vilnius University | Portland, Oregon 97227 |
Salem Hospital Regional Cancer Center | Salem, Oregon 97309 |
West Florida Cancer Institute at West Florida Hospital - Pensacola | Pensacola, Florida 32514 |
Regional Cancer Center at Memorial Medical Center | Springfield, Illinois 62781-0001 |
Hematology Oncology Associates of Eastern Idaho | Idaho Falls, Idaho 83404 |
Good Samaritan Health Systems | Kearney, Nebraska 68847 |
Freeman Cancer Institute at Freeman Health System | Joplin, Missouri 64803-2644 |