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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Malignant Neoplasms of Eye, Brain and Other Parts of Central Nervous System

Thank you

Trial Information

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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Survival

Outcome Time Frame:

assessed every 6 weeks for 42 weeks, then every 4 months for one year, followed by every 6 months for years 2 through 5

Safety Issue:

No

Principal Investigator

Deborah T. Blumenthal, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Utah

Authority:

United States: Federal Government

Study ID:

CDR0000068656

NCT ID:

NCT00017147

Start Date:

September 2001

Completion Date:

November 2012

Related Keywords:

  • Malignant Neoplasms of Eye, Brain and Other Parts of Central Nervous System
  • adult glioblastoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Neoplasms
  • Eye Neoplasms
  • Glioblastoma
  • Gliosarcoma

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