S0001 RT and Carmustine With or Without O6BG in Patients With New Glioblastoma Multiforme or Gliosarcoma
NCT ID: NCT00017147
Last Updated: 2013-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
183 participants
INTERVENTIONAL
2001-09-30
2012-11-30
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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O6-BG + BCNU + Radiation Therapy
O6-BG: 120 mg/m\^2 IV over 1 hour on day 1 of each cycle BCNU: 40 mg/m\^2 IV over 1 hour on day 1 of each cycle 6 hours after O6-BG dose. Radiation Therapy: 5 days/week using one fraction per day and a dose of 180 cGy per fraction. Initial target volume is dose of 5040 cGy in 28 fractions with boost target volume of 1080 cGy in 6 fractions.
carmustine
40 mg/m\^2 IV over 1 hour on day 1 of each cycle 6 hours after O6-BG dose for experimental arm with O6=BG.
200 mg/m\^2 IV over 1 hour on day 2 of each cycle for the active comparator arm.
radiation therapy
5 days/week using one fraction per day and a dose of 180 cGy per fraction. Initial target volume is dose of 5040 cGy in 28 fractions with boost target volume of 1080 cGy in 6 fractions.
O6-Benzylguanine
120 mg/m\^2 IV over 1 hour on day 1 of each cycle
BCNU + Radiation Therapy
BCNU: 40 mg/m\^2 IV over 1 hour on day 1 of each cycle. Radiation Therapy: 5 days/week using one fraction per day and a dose of 180 cGy per fraction. Initial target volume is dose of 5040 cGy in 28 fractions with boost target volume of 1080 cGy in 6 fractions.
carmustine
40 mg/m\^2 IV over 1 hour on day 1 of each cycle 6 hours after O6-BG dose for experimental arm with O6=BG.
200 mg/m\^2 IV over 1 hour on day 2 of each cycle for the active comparator arm.
radiation therapy
5 days/week using one fraction per day and a dose of 180 cGy per fraction. Initial target volume is dose of 5040 cGy in 28 fractions with boost target volume of 1080 cGy in 6 fractions.
Interventions
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carmustine
40 mg/m\^2 IV over 1 hour on day 1 of each cycle 6 hours after O6-BG dose for experimental arm with O6=BG.
200 mg/m\^2 IV over 1 hour on day 2 of each cycle for the active comparator arm.
radiation therapy
5 days/week using one fraction per day and a dose of 180 cGy per fraction. Initial target volume is dose of 5040 cGy in 28 fractions with boost target volume of 1080 cGy in 6 fractions.
O6-Benzylguanine
120 mg/m\^2 IV over 1 hour on day 1 of each cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed glioblastoma multiforme or gliosarcoma
* Biopsy or surgical resection within the past 28 days
* MRI\* with gadolinium performed before registration
* Patients who undergo a simple biopsy only require preoperative MRI\* with gadolinium
* No more than 2 noncontiguous tumor sites based on T2-weighted MRI (in 3 dimensions)\*
* No prior radiotherapy-delivered cephalad to the interspace between the seventh cervical and the first thoracic vertebral body NOTE: \*If an MRI is not medically feasible, patients may have a CT scan with contrast
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Zubrod 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count at least 3,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 8 g/dL
Hepatic:
* Bilirubin no greater than 2 times upper limit of normal (ULN)
* SGOT/SGPT no greater than 2 times ULN
* Alkaline phosphatase no greater than 2 times ULN
* PT/PTT no greater than 1.2 times ULN
Renal:
* Not specified
Cardiac:
* No severe cardiac disease, including any of the following:
* Uncontrolled arrhythmias or conduction defects
* Major problems with edema (e.g., residual swelling in the legs from deep vein thrombosis)
* Recent coronary artery disease
* Poorly controlled hypertension (i.e., diastolic blood pressure greater than 110 mm Hg and/or systolic blood pressure greater than 180 mm Hg)
Pulmonary:
* DLCO at least 70% of predicted
* No severe pulmonary disease
Other:
* HIV negative
* No severe Cushing's syndrome
* No known allergies to any of the study drugs
* No major psychiatric illness
* No poorly controlled diabetes complicated by steroid treatment
* No other medical illness that cannot be adequately controlled or that would preclude study participation
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy
* No other concurrent antitumor chemotherapy
Endocrine therapy:
* No concurrent hormonal therapy except postmenopausal estrogen replacement therapy
* Corticosteroids at stable or decreasing dose for tumor edema allowed
Radiotherapy:
* See Disease Characteristics
* No prior radiotherapy
* No other concurrent radiotherapy (including intensity-modulated radiotherapy) to the index lesion(s)
Surgery:
* See Disease Characteristics
* No concurrent antitumor surgery
Other:
* No other concurrent investigational drugs
* No other concurrent antineoplastic drugs or therapy
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
SWOG Cancer Research Network
NETWORK
Responsible Party
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Principal Investigators
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Deborah T. Blumenthal, MD
Role: STUDY_CHAIR
University of Utah
Alexander M. Spence, MD
Role: STUDY_CHAIR
University of Washington
Keith J. Stelzer, MD, PhD
Role: STUDY_CHAIR
Celilo Cancer Center at Mid-Columbia Medical Center
Locations
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Alaska Regional Hospital Cancer Center
Anchorage, Alaska, United States
Banner Good Samaritan Medical Center
Phoenix, Arizona, United States
CCOP - Western Regional, Arizona
Phoenix, Arizona, United States
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
Banner Thunderbird Medical Center
Phoenix, Arizona, United States
North Bay Cancer Center
Fairfield, California, United States
Memorial Hospital Cancer Center
Colorado Springs, Colorado, United States
St. Anthony Central Hospital
Denver, Colorado, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, United States
North Colorado Medical Center
Greeley, Colorado, United States
McKee Medical Center
Loveland, Colorado, United States
St. Anthony North Hospital
Westminster, Colorado, United States
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, United States
West Florida Cancer Institute at West Florida Hospital - Pensacola
Pensacola, Florida, United States
Piedmont Hospital
Atlanta, Georgia, United States
CCOP - Atlanta Regional
Atlanta, Georgia, United States
Northside Hospital Cancer Center
Atlanta, Georgia, United States
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, United States
WellStar Cobb Hospital
Austell, Georgia, United States
Charles B. Eberhart Cancer Center at DeKalb Medical Center
Decatur, Georgia, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Gwinnett Medical Center
Lawrenceville, Georgia, United States
Kennestone Cancer Center at Wellstar Kennestone Hospital
Marietta, Georgia, United States
Southern Regional Medical Center
Riverdale, Georgia, United States
Hematology Oncology Associates of Eastern Idaho
Idaho Falls, Idaho, United States
Saint Anthony's Hospital at Saint Anthony's Health Center
Alton, Illinois, United States
University of Illinois at Chicago Cancer Center
Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago Westside Hospital
Chicago, Illinois, United States
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, United States
St. Francis Hospital and Health Centers
Beech Grove, Indiana, United States
Genesis Regional Cancer Center at Genesis Medical Center
Davenport, Iowa, United States
Genesis Medical Center - West Campus
Davenport, Iowa, United States
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States
Cancer Center of Kansas, P.A. - El Dorado
El Dorado, Kansas, United States
Veterans Affairs Medical Center - Kansas City
Kansas City, Kansas, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States
Cancer Center of Kansas - Kingman
Kingman, Kansas, United States
Southwest Medical Center
Liberal, Kansas, United States
Cancer Center of Kansas - Newton
Newton, Kansas, United States
Cancer Center of Kansas, P.A. - Parsons
Parsons, Kansas, United States
Pratt Cancer Center of Kansas
Pratt, Kansas, United States
Cancer Center of Kansas - Salina
Salina, Kansas, United States
Salina Regional Health Center
Salina, Kansas, United States
Stormont-Vail Cancer Center
Topeka, Kansas, United States
St. Francis Comprehensive Cancer Center
Topeka, Kansas, United States
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States
Associates in Womens Health
Wichita, Kansas, United States
Cancer Center of Kansas, P.A.
Wichita, Kansas, United States
Cancer Center of Kansas, P.A. - Wichita
Wichita, Kansas, United States
CCOP - Wichita
Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States
Wesley Medical Center
Wichita, Kansas, United States
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States
Baton Rouge General Regional Cancer Center
Baton Rouge, Louisiana, United States
Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge, Louisiana, United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States
Medical Center of Louisiana - New Orleans
New Orleans, Louisiana, United States
Battle Creek Health System Cancer Care Center
Battle Creek, Michigan, United States
Mecosta County General Hospital
Big Rapids, Michigan, United States
CCOP - Grand Rapids
Grand Rapids, Michigan, United States
Lacks Cancer Center at Saint Mary's Mercy Medical Center
Grand Rapids, Michigan, United States
Spectrum Health Cancer Care - Butterworth Campus
Grand Rapids, Michigan, United States
Metropolitan Hospital
Grand Rapids, Michigan, United States
Holland Community Hospital
Holland, Michigan, United States
Hackley Hospital
Muskegon, Michigan, United States
Northern Michigan Hospital
Petoskey, Michigan, United States
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
St. Francis Medical Center
Cape Girardeau, Missouri, United States
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
Gape Girardeau, Missouri, United States
Freeman Cancer Institute at Freeman Health System
Joplin, Missouri, United States
CCOP - Kansas City
Kansas City, Missouri, United States
St. John's Regional Health Center
Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, United States
David C. Pratt Cancer Center at St. John's Mercy
St Louis, Missouri, United States
CCOP - Montana Cancer Consortium
Billings, Montana, United States
Deaconess Billings Clinic - Downtown
Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States
Northern Rockies Radiation Oncology Center
Billings, Montana, United States
St. Vincent Healthcare
Billings, Montana, United States
Deaconess Billings Clinic Cancer Center
Billings, Montana, United States
Bozeman Deaconess Hospital
Bozeman, Montana, United States
Internal Medicine Associates of Bozeman
Bozeman, Montana, United States
St. James Community Hospital
Butte, Montana, United States
Great Falls Clinic
Great Falls, Montana, United States
Sletten Regional Cancer Institute
Great Falls, Montana, United States
St. Peter's Hospital
Helena, Montana, United States
Glacier Oncology, PLLC
Kalispell, Montana, United States
Kalispell Medical Oncology
Kalispell, Montana, United States
Eastern Montana Cancer Center
Miles City, Montana, United States
Community Medical Center
Missoula, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States
Good Samaritan Health Systems
Kearney, Nebraska, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States
Adena Regional Medical Center
Chillicothe, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States
CCOP - Columbus
Columbus, Ohio, United States
Grant Riverside Cancer Services
Columbus, Ohio, United States
Mount Carmel West Hospital
Columbus, Ohio, United States
Doctors Hospital at Ohio Health
Columbus, Ohio, United States
Grandview Hospital
Dayton, Ohio, United States
Good Samaritan Hospital
Dayton, Ohio, United States
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States
Samaritan North Cancer Care Center
Dayton, Ohio, United States
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States
CCOP - Dayton
Dayton, Ohio, United States
Grady Memorial Hospital
Delaware, Ohio, United States
Community Oncology Group - Independence
Independence, Ohio, United States
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States
Fairfield Medical Center
Lancaster, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States
Middletown Regional Hospital
Middletown, Ohio, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, United States
Mercy Medical Center Oncology Unit
Springfield, Ohio, United States
Community Hospital of Springfield and Clark County
Springfield, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
Westerville, Ohio, United States
Cleveland Clinic - Wooster
Wooster, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States
Genesis - Good Samaritan Hospital
Zanesville, Ohio, United States
Legacy Mount Hood Medical Center
Glesham, Oregon, United States
Providence Milwaukie Hospital
Milwaukie, Oregon, United States
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
Portland, Oregon, United States
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States
CCOP - Columbia River Oncology Program
Portland, Oregon, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
Institute of Oncology at Vilnius University
Portland, Oregon, United States
Salem Hospital Regional Cancer Center
Salem, Oregon, United States
Legacy Meridian Park Hospital
Tualatin, Oregon, United States
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
Kingsport, Tennessee, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
Wilford Hall Medical Center
Lackland Air Force Base, Texas, United States
CCOP - Scott and White Hospital
Temple, Texas, United States
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States
Danville Regional Medical Center
Danville, Virginia, United States
St. Joseph Hospital Community Cancer Center
Bellingham, Washington, United States
Olympic Hematology and Oncology
Bremerton, Washington, United States
St. Francis Hospital
Federal Way, Washington, United States
Skagit Valley Hospital Cancer Care Center
Mount Vernon, Washington, United States
Capital Medical Center
Olympia, Washington, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Group Health Central Hospital
Seattle, Washington, United States
Harborview Medical Center
Seattle, Washington, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States
North Puget Oncology at United General Hospital
Sedro-Woolley, Washington, United States
Cancer Care Northwest - Spokane South
Spokane, Washington, United States
Allenmore Hospital
Tacoma, Washington, United States
CCOP - Northwest
Tacoma, Washington, United States
St. Clare Hospital
Tacoma, Washington, United States
Southwest Washington Medical Center Cancer Center
Vancouver, Washington, United States
Central Washington Hospital
Wenatchee, Washington, United States
Wenatchee Valley Clinic
Wenatchee, Washington, United States
Welch Cancer Center
Sheridan, Wyoming, United States
Countries
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References
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Blumenthal DT, Wade M, Rankin CJ, et al.: MGMT methylation in newly-diagnosed glioblastoma multiforme (GBM): from the S0001 phase III study of radiation therapy (RT) and O6-benzylguanine, (O6BG) plus BCNU versus RT and BCNU alone for newly diagnosed GBM. [Abstract] J Clin Oncol 24 (Suppl 18): A-1512, 2006.
Quezado M, Ronchetti R, Rapkiewicz A, Santi M, Blumenthal DT, Rushing EJ. Chromogenic in situ hybridization accurately identifies EGFR amplification in small cell glioblastoma multiforme, a common subtype of primary GBM. Clin Neuropathol. 2005 Jul-Aug;24(4):163-9.
Blumenthal DT, Rankin C, Stelzer KJ, Spence AM, Sloan AE, Moore DF Jr, Padula GD, Schulman SB, Wade ML, Rushing EJ. A Phase III study of radiation therapy (RT) and O(6)-benzylguanine + BCNU versus RT and BCNU alone and methylation status in newly diagnosed glioblastoma and gliosarcoma: Southwest Oncology Group (SWOG) study S0001. Int J Clin Oncol. 2015 Aug;20(4):650-8. doi: 10.1007/s10147-014-0769-0. Epub 2014 Nov 19.
Other Identifiers
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S0001
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000068656
Identifier Type: -
Identifier Source: org_study_id
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