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| Sponsor: | Southwest Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00017147 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. O6-benzylguanine may help carmustine kill more tumor cells by making tumor cells more sensitive to the drug. It is not yet known whether radiation therapy and carmustine are more effective with or without O6-benzylguanine.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus carmustine with or without O6-benzylguanine in treating patients who have newly diagnosed glioblastoma multiforme or gliosarcoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: O6-benzylguanine Drug: carmustine Radiation: radiation therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | 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 |
| Study Start Date: | September 2001 |
OBJECTIVES:
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.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed glioblastoma multiforme or gliosarcoma
Biopsy or surgical resection within the past 28 days
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiac:
No severe cardiac disease, including any of the following:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Hide Study Locations| United States, Alaska | |
| Alaska Regional Hospital Cancer Center | |
| Anchorage, Alaska, United States, 99508 | |
| United States, Arizona | |
| Banner Good Samaritan Medical Center | |
| Phoenix, Arizona, United States, 85006 | |
| Banner Thunderbird Medical Center | |
| Phoenix, Arizona, United States, 85306 | |
| CCOP - Western Regional, Arizona | |
| Phoenix, Arizona, United States, 85006 | |
| St. Joseph's Hospital and Medical Center | |
| Phoenix, Arizona, United States, 85013 | |
| United States, California | |
| North Bay Cancer Center | |
| Fairfield, California, United States, 94533 | |
| United States, Colorado | |
| Exempla Lutheran Medical Center | |
| Wheat Ridge, Colorado, United States, 80033 | |
| McKee Medical Center | |
| Loveland, Colorado, United States, 80539 | |
| Memorial Hospital Cancer Center | |
| Colorado Springs, Colorado, United States, 80909 | |
| North Colorado Medical Center | |
| Greeley, Colorado, United States, 80631 | |
| St. Anthony Central Hospital | |
| Denver, Colorado, United States, 80204 | |
| St. Anthony North Hospital | |
| Westminster, Colorado, United States, 80030 | |
| University of Colorado Cancer Center at University of Colorado Health Sciences Center | |
| Denver, Colorado, United States, 80217-3364 | |
| United States, Florida | |
| West Florida Cancer Institute at West Florida Hospital - Pensacola | |
| Pensacola, Florida, United States, 32514 | |
| United States, Georgia | |
| CCOP - Atlanta Regional | |
| Atlanta, Georgia, United States, 30342 | |
| Northside Hospital Cancer Center | |
| Atlanta, Georgia, United States, 30342 | |
| Gwinnett Medical Center | |
| Lawrenceville, Georgia, United States, 30045 | |
| Kennestone Cancer Center at Wellstar Kennestone Hospital | |
| Marietta, Georgia, United States, 30060 | |
| Northeast Georgia Medical Center | |
| Gainesville, Georgia, United States, 30501 | |
| Charles B. Eberhart Cancer Center at DeKalb Medical Center | |
| Decatur, Georgia, United States, 30033 | |
| Piedmont Hospital | |
| Atlanta, Georgia, United States, 30309 | |
| Saint Joseph's Hospital of Atlanta | |
| Atlanta, Georgia, United States, 30342 | |
| Southern Regional Medical Center | |
| Riverdale, Georgia, United States, 30274 | |
| WellStar Cobb Hospital | |
| Austell, Georgia, United States, 30106 | |
| United States, Idaho | |
| Hematology Oncology Associates of Eastern Idaho | |
| Idaho Falls, Idaho, United States, 83404 | |
| United States, Illinois | |
| University of Illinois at Chicago Cancer Center | |
| Chicago, Illinois, United States, 60612 | |
| Good Samaritan Regional Health Center | |
| Mt. Vernon, Illinois, United States, 62864 | |
| Regional Cancer Center at Memorial Medical Center | |
| Springfield, Illinois, United States, 62781-0001 | |
| Saint Anthony's Hospital at Saint Anthony's Health Center | |
| Alton, Illinois, United States, 62002 | |
| Decatur Memorial Hospital Cancer Care Institute | |
| Decatur, Illinois, United States, 62526 | |
| Veterans Affairs Medical Center - Chicago Westside Hospital | |
| Chicago, Illinois, United States, 60612 | |
| United States, Indiana | |
| St. Francis Hospital and Health Centers | |
| Beech Grove, Indiana, United States, 46107 | |
| United States, Iowa | |
| Genesis Medical Center - West Campus | |
| Davenport, Iowa, United States, 52804 | |
| Genesis Regional Cancer Center at Genesis Medical Center | |
| Davenport, Iowa, United States, 52803 | |
| United States, Kansas | |
| Associates in Womens Health | |
| Wichita, Kansas, United States, 67203 | |
| Cancer Center of Kansas - Salina | |
| Salina, Kansas, United States, 67042 | |
| Cancer Center of Kansas - Dodge City | |
| Dodge City, Kansas, United States, 67801 | |
| Cancer Center of Kansas - Kingman | |
| Kingman, Kansas, United States, 67068 | |
| Cancer Center of Kansas - Newton | |
| Newton, Kansas, United States, 67114 | |
| Cancer Center of Kansas - Chanute | |
| Chanute, Kansas, United States, 66720 | |
| Cancer Center of Kansas - Wellington | |
| Wellington, Kansas, United States, 67152 | |
| Cancer Center of Kansas - Winfield | |
| Winfield, Kansas, United States, 67156 | |
| Cancer Center of Kansas, P.A. - Wichita | |
| Wichita, Kansas, United States, 67214 | |
| Cancer Center of Kansas, P.A. - El Dorado | |
| El Dorado, Kansas, United States, 67042 | |
| Cancer Center of Kansas, P.A. - Parsons | |
| Parsons, Kansas, United States, 67357 | |
| Cancer Center of Kansas, P.A. | |
| Wichita, Kansas, United States, 67208 | |
| Southwest Medical Center | |
| Liberal, Kansas, United States, 67901 | |
| Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160 | |
| Pratt Cancer Center of Kansas | |
| Pratt, Kansas, United States, 67124 | |
| Salina Regional Health Center | |
| Salina, Kansas, United States, 67401 | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214 | |
| St. Francis Comprehensive Cancer Center | |
| Topeka, Kansas, United States, 66606 | |
| Stormont-Vail Cancer Center | |
| Topeka, Kansas, United States, 66604 | |
| Veterans Affairs Medical Center - Kansas City | |
| Kansas City, Kansas, United States, 64128 | |
| Via Christi Cancer Center at Via Christi Regional Medical Center | |
| Wichita, Kansas, United States, 67214 | |
| Wesley Medical Center | |
| Wichita, Kansas, United States, 67214 | |
| United States, Louisiana | |
| Baton Rouge General Regional Cancer Center | |
| Baton Rouge, Louisiana, United States, 70806 | |
| Mary Bird Perkins Cancer Center - Baton Rouge | |
| Baton Rouge, Louisiana, United States, 70809 | |
| MBCCOP - LSU Health Sciences Center | |
| New Orleans, Louisiana, United States, 70112 | |
| Medical Center of Louisiana - New Orleans | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Michigan | |
| Battle Creek Health System Cancer Care Center | |
| Battle Creek, Michigan, United States, 49017 | |
| CCOP - Grand Rapids | |
| Grand Rapids, Michigan, United States, 49503 | |
| Hackley Hospital | |
| Muskegon, Michigan, United States, 49443 | |
| Holland Community Hospital | |
| Holland, Michigan, United States, 49423 | |
| Lacks Cancer Center at Saint Mary's Mercy Medical Center | |
| Grand Rapids, Michigan, United States, 49503 | |
| Mecosta County General Hospital | |
| Big Rapids, Michigan, United States, 49307 | |
| William Beaumont Hospital - Royal Oak Campus | |
| Royal Oak, Michigan, United States, 48073 | |
| Munson Medical Center | |
| Traverse City, Michigan, United States, 49684 | |
| Northern Michigan Hospital | |
| Petoskey, Michigan, United States, 49770 | |
| Spectrum Health Cancer Care - Butterworth Campus | |
| Grand Rapids, Michigan, United States, 49503 | |
| Metropolitan Hospital | |
| Grand Rapids, Michigan, United States, 49506 | |
| United States, Mississippi | |
| University of Mississippi Medical Center | |
| Jackson, Mississippi, United States, 39216 | |
| United States, Missouri | |
| CCOP - Kansas City | |
| Kansas City, Missouri, United States, 64131 | |
| CCOP - St. Louis-Cape Girardeau | |
| St. Louis, Missouri, United States, 63141 | |
| David C. Pratt Cancer Center at St. John's Mercy | |
| St. Louis, Missouri, United States, 63141 | |
| Freeman Cancer Institute at Freeman Health System | |
| Joplin, Missouri, United States, 64804 | |
| Hulston Cancer Center at Cox Medical Center South | |
| Springfield, Missouri, United States, 65807 | |
| Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital | |
| Gape Girardeau, Missouri, United States, 63701 | |
| St. Francis Medical Center | |
| Cape Girardeau, Missouri, United States, 63701 | |
| St. John's Regional Health Center | |
| Springfield, Missouri, United States, 65804 | |
| United States, Montana | |
| Bozeman Deaconess Hospital | |
| Bozeman, Montana, United States, 59715 | |
| CCOP - Montana Cancer Consortium | |
| Billings, Montana, United States, 59101 | |
| Community Medical Center | |
| Missoula, Montana, United States, 59801 | |
| Deaconess Billings Clinic - Downtown | |
| Billings, Montana, United States, 59101 | |
| Deaconess Billings Clinic Cancer Center | |
| Billings, Montana, United States, 59107 | |
| Eastern Montana Cancer Center | |
| Miles City, Montana, United States, 59301 | |
| Glacier Oncology, PLLC | |
| Kalispell, Montana, United States, 59901 | |
| Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | |
| Missoula, Montana, United States, 59802 | |
| Hematology-Oncology Centers of the Northern Rockies - Billings | |
| Billings, Montana, United States, 59101 | |
| Internal Medicine Associates of Bozeman | |
| Bozeman, Montana, United States, 59715 | |
| Kalispell Medical Oncology | |
| Kalispell, Montana, United States, 59901 | |
| Great Falls Clinic | |
| Great Falls, Montana, United States, 59405 | |
| Montana Cancer Specialists at Montana Cancer Center | |
| Missoula, Montana, United States, 59802 | |
| Northern Rockies Radiation Oncology Center | |
| Billings, Montana, United States, 59101 | |
| Sletten Regional Cancer Institute | |
| Great Falls, Montana, United States, 59405 | |
| St. James Community Hospital | |
| Butte, Montana, United States, 59701 | |
| St. Peter's Hospital | |
| Helena, Montana, United States, 59601 | |
| St. Vincent Healthcare | |
| Billings, Montana, United States, 59101 | |
| United States, Nebraska | |
| Good Samaritan Health Systems | |
| Kearney, Nebraska, United States, 68847 | |
| United States, New York | |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| United States, North Carolina | |
| Presbyterian Cancer Center at Presbyterian Hospital | |
| Charlotte, North Carolina, United States, 28233 | |
| Wayne Memorial Hospital, Incorporated | |
| Goldsboro, North Carolina, United States, 27534 | |
| United States, Ohio | |
| Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital | |
| Westerville, Ohio, United States, 43081 | |
| Adena Regional Medical Center | |
| Chillicothe, Ohio, United States, 54601 | |
| CCOP - Columbus | |
| Columbus, Ohio, United States, 43215 | |
| CCOP - Dayton | |
| Dayton, Ohio, United States, 45429 | |
| Charles F. Kettering Memorial Hospital | |
| Kettering, Ohio, United States, 45429 | |
| Cleveland Clinic - Wooster | |
| Wooster, Ohio, United States, 44691 | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| Community Hospital of Springfield and Clark County | |
| Springfield, Ohio, United States, 45505 | |
| Community Oncology Group - Independence | |
| Independence, Ohio, United States, 44131 | |
| David L. Rike Cancer Center at Miami Valley Hospital | |
| Dayton, Ohio, United States, 45409 | |
| Doctors Hospital at Ohio Health | |
| Columbus, Ohio, United States, 43228 | |
| Fairfield Medical Center | |
| Lancaster, Ohio, United States, 43130 | |
| Genesis - Good Samaritan Hospital | |
| Zanesville, Ohio, United States, 43701 | |
| Good Samaritan Hospital | |
| Dayton, Ohio, United States, 45406 | |
| Grady Memorial Hospital | |
| Delaware, Ohio, United States, 43015 | |
| Grandview Hospital | |
| Dayton, Ohio, United States, 45405 | |
| Grant Riverside Cancer Services | |
| Columbus, Ohio, United States, 43215 | |
| Mercy Medical Center Oncology Unit | |
| Springfield, Ohio, United States, 45504 | |
| Middletown Regional Hospital | |
| Middletown, Ohio, United States, 45044 | |
| Licking Memorial Cancer Care Program at Licking Memorial Hospital | |
| Newark, Ohio, United States, 43055 | |
| Mount Carmel West Hospital | |
| Columbus, Ohio, United States, 43222 | |
| Riverside Methodist Hospital Cancer Care | |
| Columbus, Ohio, United States, 43214 | |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | |
| Xenia, Ohio, United States, 45385 | |
| Samaritan North Cancer Care Center | |
| Dayton, Ohio, United States, 45415 | |
| Strecker Cancer Center at Marietta Memorial Hospital | |
| Marietta, Ohio, United States, 45750 | |
| UVMC Cancer Care Center at Upper Valley Medical Center | |
| Troy, Ohio, United States, 45373 | |
| Veterans Affairs Medical Center - Dayton | |
| Dayton, Ohio, United States, 45428 | |
| United States, Oregon | |
| CCOP - Columbia River Oncology Program | |
| Portland, Oregon, United States, 97225 | |
| Institute of Oncology at Vilnius University | |
| Portland, Oregon, United States, 97227 | |
| Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center | |
| Portland, Oregon, United States, 97210 | |
| Legacy Meridian Park Hospital | |
| Tualatin, Oregon, United States, 97062 | |
| Legacy Mount Hood Medical Center | |
| Glesham, Oregon, United States, 97030 | |
| Providence Cancer Center at Providence Portland Medical Center | |
| Portland, Oregon, United States, 97213 | |
| Providence Milwaukie Hospital | |
| Milwaukie, Oregon, United States, 97222 | |
| Providence St. Vincent Medical Center | |
| Portland, Oregon, United States, 97225 | |
| Salem Hospital Regional Cancer Center | |
| Salem, Oregon, United States, 97309 | |
| United States, Tennessee | |
| Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center | |
| Kingsport, Tennessee, United States, 37660 | |
| United States, Texas | |
| Brooke Army Medical Center | |
| Fort Sam Houston, Texas, United States, 78234 | |
| CCOP - Scott and White Hospital | |
| Temple, Texas, United States, 76508 | |
| Wilford Hall Medical Center | |
| Lackland AFB, Texas, United States, 78236 | |
| United States, Utah | |
| Huntsman Cancer Institute at University of Utah | |
| Salt Lake City, Utah, United States, 84112 | |
| United States, Virginia | |
| Danville Regional Medical Center | |
| Danville, Virginia, United States, 24541 | |
| United States, Washington | |
| Allenmore Hospital | |
| Tacoma, Washington, United States, 98405 | |
| Cancer Care Northwest - Spokane South | |
| Spokane, Washington, United States, 99202 | |
| Capital Medical Center | |
| Olympia, Washington, United States, 98507 | |
| CCOP - Northwest | |
| Tacoma, Washington, United States, 98405 | |
| North Puget Oncology at United General Hospital | |
| Sedro-Wooley, Washington, United States, 98284 | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98104 | |
| Group Health Central Hospital | |
| Seattle, Washington, United States, 98104 | |
| Harborview Medical Center | |
| Seattle, Washington, United States, 98104 | |
| Central Washington Hospital | |
| Wenatchee, Washington, United States, 98801 | |
| Olympic Hematology and Oncology | |
| Bremerton, Washington, United States, 98310 | |
| Skagit Valley Hospital Cancer Care Center | |
| Mt. Vernon, Washington, United States, 98273 | |
| Southwest Washington Medical Center Cancer Center | |
| Vancouver, Washington, United States, 98668 | |
| St. Clare Hospital | |
| Tacoma, Washington, United States, 98499 | |
| St. Francis Hospital | |
| Federal Way, Washington, United States, 98003 | |
| St. Joseph Hospital Community Cancer Center | |
| Bellingham, Washington, United States, 98225 | |
| Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | |
| Seattle, Washington, United States, 98114 | |
| University Cancer Center at University of Washington Medical Center | |
| Seattle, Washington, United States, 98195 | |
| Wenatchee Valley Clinic | |
| Wenatchee, Washington, United States, 98801 | |
| United States, Wyoming | |
| Welch Cancer Center | |
| Sheridan, Wyoming, United States, 82801 | |
| Investigator: | Deborah T. Blumenthal, MD | University of Utah |
| Investigator: | Alexander M. Spence, MD | University of Washington |
| Investigator: | Keith J. Stelzer, MD, PhD | Celilo Cancer Center at Mid-Columbia Medical Center |
More Information
| Study ID Numbers: | CDR0000068656, SWOG-S0001 |
| Study First Received: | June 6, 2001 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00017147 History of Changes |
| Health Authority: | United States: Federal Government |
|
adult glioblastoma adult giant cell glioblastoma adult gliosarcoma |
|
Glioblastoma Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Astrocytoma Antineoplastic Agents Carmustine Nervous System Diseases Neoplasms, Nerve Tissue Enzyme Inhibitors Central Nervous System Neoplasms Pharmacologic Actions Neuroectodermal Tumors |
Neoplasms Neoplasms by Site Therapeutic Uses Neoplasms, Germ Cell and Embryonal O(6)-benzylguanine Antineoplastic Agents, Alkylating Glioma Gliosarcoma Neoplasms, Neuroepithelial Alkylating Agents Nervous System Neoplasms Neoplasms, Glandular and Epithelial |