S0001 RT and Carmustine With or Without O6BG in Patients With New Glioblastoma Multiforme or Gliosarcoma
Malignant Neoplasms of Eye, Brain and Other Parts of Central Nervous System
About this trial
This is an interventional treatment trial for Malignant Neoplasms of Eye, Brain and Other Parts of Central Nervous System focused on measuring adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma
Eligibility Criteria
DISEASE CHARACTERISTICS: 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
Sites / Locations
- Alaska Regional Hospital Cancer Center
- Banner Good Samaritan Medical Center
- CCOP - Western Regional, Arizona
- St. Joseph's Hospital and Medical Center
- Banner Thunderbird Medical Center
- North Bay Cancer Center
- Memorial Hospital Cancer Center
- St. Anthony Central Hospital
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
- North Colorado Medical Center
- McKee Medical Center
- St. Anthony North Hospital
- Exempla Lutheran Medical Center
- West Florida Cancer Institute at West Florida Hospital - Pensacola
- Piedmont Hospital
- CCOP - Atlanta Regional
- Northside Hospital Cancer Center
- Saint Joseph's Hospital of Atlanta
- WellStar Cobb Hospital
- Charles B. Eberhart Cancer Center at DeKalb Medical Center
- Northeast Georgia Medical Center
- Gwinnett Medical Center
- Kennestone Cancer Center at Wellstar Kennestone Hospital
- Southern Regional Medical Center
- Hematology Oncology Associates of Eastern Idaho
- Saint Anthony's Hospital at Saint Anthony's Health Center
- University of Illinois at Chicago Cancer Center
- Veterans Affairs Medical Center - Chicago Westside Hospital
- Decatur Memorial Hospital Cancer Care Institute
- Good Samaritan Regional Health Center
- Regional Cancer Center at Memorial Medical Center
- St. Francis Hospital and Health Centers
- Genesis Regional Cancer Center at Genesis Medical Center
- Genesis Medical Center - West Campus
- Cancer Center of Kansas - Chanute
- Cancer Center of Kansas - Dodge City
- Cancer Center of Kansas, P.A. - El Dorado
- Veterans Affairs Medical Center - Kansas City
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
- Cancer Center of Kansas - Kingman
- Southwest Medical Center
- Cancer Center of Kansas - Newton
- Cancer Center of Kansas, P.A. - Parsons
- Pratt Cancer Center of Kansas
- Cancer Center of Kansas - Salina
- Salina Regional Health Center
- Stormont-Vail Cancer Center
- St. Francis Comprehensive Cancer Center
- Cancer Center of Kansas - Wellington
- Associates in Womens Health
- Cancer Center of Kansas, P.A.
- Cancer Center of Kansas, P.A. - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Wesley Medical Center
- Cancer Center of Kansas - Winfield
- Baton Rouge General Regional Cancer Center
- Mary Bird Perkins Cancer Center - Baton Rouge
- MBCCOP - LSU Health Sciences Center
- Medical Center of Louisiana - New Orleans
- Battle Creek Health System Cancer Care Center
- Mecosta County General Hospital
- CCOP - Grand Rapids
- Lacks Cancer Center at Saint Mary's Mercy Medical Center
- Spectrum Health Cancer Care - Butterworth Campus
- Metropolitan Hospital
- Holland Community Hospital
- Hackley Hospital
- Northern Michigan Hospital
- William Beaumont Hospital - Royal Oak Campus
- Munson Medical Center
- University of Mississippi Medical Center
- St. Francis Medical Center
- Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
- Freeman Cancer Institute at Freeman Health System
- CCOP - Kansas City
- St. John's Regional Health Center
- Hulston Cancer Center at Cox Medical Center South
- CCOP - St. Louis-Cape Girardeau
- David C. Pratt Cancer Center at St. John's Mercy
- CCOP - Montana Cancer Consortium
- Deaconess Billings Clinic - Downtown
- Hematology-Oncology Centers of the Northern Rockies - Billings
- Northern Rockies Radiation Oncology Center
- St. Vincent Healthcare
- Deaconess Billings Clinic Cancer Center
- Bozeman Deaconess Hospital
- Internal Medicine Associates of Bozeman
- St. James Community Hospital
- Great Falls Clinic
- Sletten Regional Cancer Institute
- St. Peter's Hospital
- Glacier Oncology, PLLC
- Kalispell Medical Oncology
- Eastern Montana Cancer Center
- Community Medical Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Montana Cancer Specialists at Montana Cancer Center
- Good Samaritan Health Systems
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- Presbyterian Cancer Center at Presbyterian Hospital
- Wayne Memorial Hospital, Incorporated
- Adena Regional Medical Center
- Cleveland Clinic Taussig Cancer Center
- Riverside Methodist Hospital Cancer Care
- CCOP - Columbus
- Grant Riverside Cancer Services
- Mount Carmel West Hospital
- Doctors Hospital at Ohio Health
- Grandview Hospital
- Good Samaritan Hospital
- David L. Rike Cancer Center at Miami Valley Hospital
- Samaritan North Cancer Care Center
- Veterans Affairs Medical Center - Dayton
- CCOP - Dayton
- Grady Memorial Hospital
- Community Oncology Group - Independence
- Charles F. Kettering Memorial Hospital
- Fairfield Medical Center
- Strecker Cancer Center at Marietta Memorial Hospital
- Middletown Regional Hospital
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
- Mercy Medical Center Oncology Unit
- Community Hospital of Springfield and Clark County
- UVMC Cancer Care Center at Upper Valley Medical Center
- Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
- Cleveland Clinic - Wooster
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Genesis - Good Samaritan Hospital
- Legacy Mount Hood Medical Center
- Providence Milwaukie Hospital
- Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
- Providence Cancer Center at Providence Portland Medical Center
- CCOP - Columbia River Oncology Program
- Providence St. Vincent Medical Center
- Institute of Oncology at Vilnius University
- Salem Hospital Regional Cancer Center
- Legacy Meridian Park Hospital
- Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
- Brooke Army Medical Center
- Wilford Hall Medical Center
- CCOP - Scott and White Hospital
- Huntsman Cancer Institute at University of Utah
- Danville Regional Medical Center
- St. Joseph Hospital Community Cancer Center
- Olympic Hematology and Oncology
- St. Francis Hospital
- Skagit Valley Hospital Cancer Care Center
- Capital Medical Center
- Fred Hutchinson Cancer Research Center
- Group Health Central Hospital
- Harborview Medical Center
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
- University Cancer Center at University of Washington Medical Center
- North Puget Oncology at United General Hospital
- Cancer Care Northwest - Spokane South
- Allenmore Hospital
- CCOP - Northwest
- St. Clare Hospital
- Southwest Washington Medical Center Cancer Center
- Central Washington Hospital
- Wenatchee Valley Clinic
- Welch Cancer Center
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
O6-BG + BCNU + Radiation Therapy
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.
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.