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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 CenterSeattle, Washington  98109
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
St. Joseph's Hospital and Medical CenterPhoenix, Arizona  85001-2071
Memorial Hospital Cancer CenterColorado Springs, Colorado  80909
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - ColumbusColumbus, Ohio  43206
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
CCOP - Western Regional, ArizonaPhoenix, Arizona  85006-2726
University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010
CCOP - Grand RapidsGrand Rapids, Michigan  49503
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
CCOP - Scott and White HospitalTemple, Texas  76508
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
CCOP - NorthwestTacoma, Washington  98405-0986
Wesley Medical CenterWichita, Kansas  67214
Great Falls ClinicGreat Falls, Montana  59405
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Northside Hospital Cancer CenterAtlanta, Georgia  30342-1611
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
Wilford Hall Medical CenterLackland Air Force Base, Texas  78236-5300
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Spectrum Health Cancer Care - Butterworth CampusGrand Rapids, Michigan  49503-2560
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Alaska Regional Hospital Cancer CenterAnchorage, Alaska  99508
Banner Good Samaritan Medical CenterPhoenix, Arizona  85006
Banner Thunderbird Medical CenterPhoenix, Arizona  85306
North Colorado Medical CenterGreeley, Colorado  80631
McKee Medical CenterLoveland, Colorado  80539
Saint Anthony's Hospital at Saint Anthony's Health CenterAlton, Illinois  62002
Good Samaritan Regional Health CenterMt. Vernon, Illinois  62864
Cancer Center of Kansas - ChanuteChanute, Kansas  66720
Cancer Center of Kansas - Dodge CityDodge City, Kansas  67801
Cancer Center of Kansas, P.A. - El DoradoEl Dorado, Kansas  67042
Veterans Affairs Medical Center - Kansas CityKansas City, Kansas  64128
Cancer Center of Kansas - KingmanKingman, Kansas  67068
Southwest Medical CenterLiberal, Kansas  67901
Cancer Center of Kansas - NewtonNewton, Kansas  67114
Cancer Center of Kansas, P.A. - ParsonsParsons, Kansas  67357
Pratt Cancer Center of KansasPratt, Kansas  67124
Cancer Center of Kansas - SalinaSalina, Kansas  67042
Cancer Center of Kansas - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, P.A.Wichita, Kansas  67208
Associates in Womens HealthWichita, Kansas  67203
Cancer Center of Kansas, P.A. - WichitaWichita, Kansas  67214
Cancer Center of Kansas - WinfieldWinfield, Kansas  67156
Battle Creek Health System Cancer Care CenterBattle Creek, Michigan  49017
Mecosta County General HospitalBig Rapids, Michigan  49307
Metropolitan HospitalGrand Rapids, Michigan  49506
Lacks Cancer Center at Saint Mary's Mercy Medical CenterGrand Rapids, Michigan  49503
Holland Community HospitalHolland, Michigan  49423
Hackley HospitalMuskegon, Michigan  49443
Northern Michigan HospitalPetoskey, Michigan  49770
William Beaumont Hospital - Royal Oak CampusRoyal Oak, Michigan  48073
Munson Medical CenterTraverse City, Michigan  49684
St. Francis Medical CenterCape Girardeau, Missouri  63701
Southeast Missouri Regional Cancer Center at Southeast Missouri HospitalGape Girardeau, Missouri  63701
David C. Pratt Cancer Center at St. John's MercySt. Louis, Missouri  63141
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
St. Vincent HealthcareBillings, Montana  59101
Deaconess Billings Clinic - DowntownBillings, Montana  59101
Deaconess Billings Clinic Cancer CenterBillings, Montana  59107
Internal Medicine Associates of BozemanBozeman, Montana  59715
Bozeman Deaconess HospitalBozeman, Montana  59715
St. James Community HospitalButte, Montana  59701
Sletten Regional Cancer InstituteGreat Falls, Montana  59405
St. Peter's HospitalHelena, Montana  59601
Kalispell Medical OncologyKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Eastern Montana Cancer CenterMiles City, Montana  59301
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Community Medical CenterMissoula, Montana  59801
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Adena Regional Medical CenterChillicothe, Ohio  54601
Doctors Hospital at Ohio HealthColumbus, Ohio  43228
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Grant Riverside Cancer ServicesColumbus, Ohio  43215
Mount Carmel West HospitalColumbus, Ohio  43222
Grady Memorial HospitalDelaware, Ohio  43015
Fairfield Medical CenterLancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial HospitalMarietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial HospitalNewark, Ohio  43055
Community Hospital of Springfield and Clark CountySpringfield, Ohio  45505
Mercy Medical Center Oncology UnitSpringfield, Ohio  45504
Mount Carmel Cancer Services at Mount Carmel St. Ann's HospitalWesterville, Ohio  43081
Genesis - Good Samaritan HospitalZanesville, Ohio  43701
St. Joseph Hospital Community Cancer CenterBellingham, Washington  98225
Olympic Hematology and OncologyBremerton, Washington  98310
Skagit Valley Hospital Cancer Care CenterMt. Vernon, Washington  98273
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Harborview Medical CenterSeattle, Washington  98104
Group Health Central HospitalSeattle, Washington  98104
North Puget Oncology at United General HospitalSedro-Wooley, Washington  98284
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Central Washington HospitalWenatchee, Washington  98801
Wenatchee Valley ClinicWenatchee, Washington  98801
Welch Cancer CenterSheridan, Wyoming  82801
University of Illinois at Chicago Cancer CenterChicago, Illinois  60612
Huntsman Cancer Institute at University of UtahSalt Lake City, Utah  84112
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
Veterans Affairs Medical Center - Chicago Westside HospitalChicago, Illinois  60612
North Bay Cancer CenterFairfield, California  94533
Saint Joseph's Hospital of AtlantaAtlanta, Georgia  30342-1701
Piedmont HospitalAtlanta, Georgia  30309
WellStar Cobb HospitalAustell, Georgia  30106
Charles B. Eberhart Cancer Center at DeKalb Medical CenterDecatur, Georgia  30033
Gwinnett Medical CenterLawrenceville, Georgia  30045
Kennestone Cancer Center at Wellstar Kennestone HospitalMarietta, Georgia  30060
Southern Regional Medical CenterRiverdale, Georgia  30274-2600
Genesis Medical Center - West CampusDavenport, Iowa  52804
Genesis Regional Cancer Center at Genesis Medical CenterDavenport, Iowa  52803
Salina Regional Health CenterSalina, Kansas  67401
Stormont-Vail Cancer CenterTopeka, Kansas  66604
St. Francis Comprehensive Cancer CenterTopeka, Kansas  66606
Mary Bird Perkins Cancer Center - Baton RougeBaton Rouge, Louisiana  70809
Medical Center of Louisiana - New OrleansNew Orleans, Louisiana  70112
Samaritan North Cancer Care CenterDayton, Ohio  45415
Grandview HospitalDayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Good Samaritan HospitalDayton, Ohio  45406
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Middletown Regional HospitalMiddletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Cleveland Clinic - WoosterWooster, Ohio  44691
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Legacy Mount Hood Medical CenterGresham, Oregon  97030
Providence Milwaukie HospitalMilwaukie, Oregon  97222
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer CenterPortland, Oregon  97210
Providence Cancer Center at Providence Portland Medical CenterPortland, Oregon  97213-2967
Providence St. Vincent Medical CenterPortland, Oregon  97225
Legacy Meridian Park HospitalTualatin, Oregon  97062
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical CenterKingsport, Tennessee  37662
Danville Regional Medical CenterDanville, Virginia  24541
Southwest Washington Medical Center Cancer CenterVancouver, Washington  98668
St. Anthony Central HospitalDenver, Colorado  80204-1335
St. Anthony North HospitalWestminster, Colorado  80030
Exempla Lutheran Medical CenterWheat Ridge, Colorado  80033
Baton Rouge General Regional Cancer CenterBaton Rouge, Louisiana  70821
Community Oncology Group - IndependenceIndependence, Ohio  44131
St. Francis HospitalFederal Way, Washington  98003
St. Clare HospitalLakewood, Washington  98499-0998
Capital Medical CenterOlympia, Washington  98502
Allenmore HospitalTacoma, Washington  98411-0414
Northeast Georgia Medical CenterGainesville, Georgia  30501
St. Francis Hospital and Health CentersBeech Grove, Indiana  46107
Institute of Oncology at Vilnius UniversityPortland, Oregon  97227
Salem Hospital Regional Cancer CenterSalem, Oregon  97309
West Florida Cancer Institute at West Florida Hospital - PensacolaPensacola, Florida  32514
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
Hematology Oncology Associates of Eastern IdahoIdaho Falls, Idaho  83404
Good Samaritan Health SystemsKearney, Nebraska  68847
Freeman Cancer Institute at Freeman Health SystemJoplin, Missouri  64803-2644