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Radiation Therapy and Carmustine With or Without O6-Benzylguanine in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Radiation Therapy and Carmustine With or Without O6-Benzylguanine in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Radiation Therapy and Carmustine With or Without O6-Benzylguanine in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma Clinical research trials and Radiation Therapy and Carmustine With or Without O6-Benzylguanine in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Radiation Therapy and Carmustine With or Without O6-Benzylguanine in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma. Radiation Therapy and Carmustine With or Without O6-Benzylguanine in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Radiation Therapy and Carmustine With or Without O6-Benzylguanine in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma clinical trial. Human subjects frequently get the finest healthcare available for their Radiation Therapy and Carmustine With or Without O6-Benzylguanine in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.

Home > "R" Clinical Trials Conditions > Radiation Therapy and Carmustine With or Without O6-Benzylguanine in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma

Radiation Therapy and Carmustine With or Without O6-Benzylguanine in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma



Radiation Therapy and Carmustine With or Without O6-Benzylguanine in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma

For Condition: adult glioblastoma multiforme
Status: Recruiting
Sponsor(s): Southwest Oncology Group , National Cancer Institute (NCI)
Synopsis: 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: Randomizedphase 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.
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed glioblastoma multiforme or gliosarcoma - Biopsy or surgical resection within the past 28 days - MRI with gadolinium performed prior to 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 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
DeborahBlumenthal,  ,  Huntsman Cancer Institute

CCOP - Grand Rapids *Recruiting*
Grand Rapids,  Michigan,  49503
United States
Recruiting Kathleen  Yost 616-391-1230

MBCCOP - University of New Mexico HSC *Recruiting*
Albuquerque,  New Mexico,  87131
United States
Recruiting Cheryl  Willman 505-272-5837

Madigan Army Medical Center *Recruiting*
Tacoma,  Washington,  98431-5000
United States
Recruiting Rajat  Bannerji 253-968-2504

Veterans Affairs Medical Center - Albuquerque *Recruiting*
Albuquerque,  New Mexico,  87108-5138
United States
Recruiting Douglas  Clark 505-243-4039

Veterans Affairs Medical Center - San Antonio (Murphy) *Recruiting*
San Antonio,  Texas,  78229
United States
Recruiting Geoffrey  Weiss 210-617-5120

CCOP - Dayton *Recruiting*
Dayton,  Ohio,  45429
United States
Recruiting Howard  Gross 937-395-8678

Huntsman Cancer Institute *Recruiting*
Salt Lake City,  Utah,  84112-5550
United States
Recruiting Wolfram  Samlowski 801-585-0255

Veterans Affairs Medical Center - Charleston *Recruiting*
Charleston,  South Carolina,  29401-5799
United States
Recruiting Andrew  Turrisi 843-792-273

Celilo Cancer Center *Recruiting*
Seattle,  Washington,  98195-6043
United States
Recruiting Keith  Stelzer 541-296-1111

Veterans Affairs Outpatient Clinic - Martinez *Recruiting*
Martinez,  California,  94553
United States
Recruiting David  Gandara 925-372-2064

Veterans Affairs Medical Center - Jackson *Recruiting*
Jackson,  Mississippi,  39216
United States
Recruiting James  Thigpen 601-362-4471

Veterans Affairs Medical Center - Tucson *Recruiting*
Tucson,  Arizona,  85723
United States
Recruiting Thomas  Miller 520-792-1450 ext. 16631

Veterans Affairs Medical Center - Little Rock (McClellan) *Recruiting*
Little Rock,  Arkansas,  72205
United States
Recruiting Bart  Barlogie 501-526-2873

MBCCOP - LSU Health Sciences Center *Recruiting*
New Orleans,  Louisiana,  70112
United States
Recruiting Jill  Gilbert 504-568-5136

Cardinal Bernardin Cancer Center at Loyola University Medical Center *Recruiting*
Maywood,  Illinois,  60153-5500
United States
Recruiting Patrick  Stiff 708-327-3148

University of Mississippi Medical Center *Recruiting*
Jackson,  Mississippi,  39216-4505
United States
Recruiting James  Thigpen 601-984-5590

CCOP - Atlanta Regional *Recruiting*
Atlanta,  Georgia,  30342-1701
United States
Recruiting Thomas  Seay 404-851-2340

Veterans Affairs Medical Center - Oklahoma City *Recruiting*
Oklahoma City,  Oklahoma,  73104
United States
Recruiting Howard  Ozer 405-270-0501

MBCCOP - Howard University Cancer Center *Recruiting*
Washington D.C.,  District of Columbia,  20060
United States
Recruiting Lucile  Adams-Campbell 202-806-7697

CCOP - Columbus *Recruiting*
Columbus,  Ohio,  43206
United States
Recruiting J.  Kuebler 614-488-2118

James P. Wilmot Cancer Center at University of Rochester Medical Center *Recruiting*
Rochester,  New York,  14642
United States
Recruiting Richard  Fisher 585-275-0842

MBCCOP - Gulf Coast *Recruiting*
Mobile,  Alabama,  36607
United States
Recruiting Paul  Schwarzenberger 251-544-1013

CCOP - Bay Area Tumor Institute *Recruiting*
Oakland,  California,  94609-3305
United States
Recruiting Joseph  Szumowski 510-465-8570

MBCCOP - University of Illinois at Chicago *Recruiting*
Chicago,  Illinois,  60612
United States
Recruiting Lawrence  Feldman 312-335-3614

Hollings Cancer Center at Medical University of South Carolina *Recruiting*
Charleston,  South Carolina,  29425
United States
Recruiting Carolyn  Reed 843-792-3362

CCOP - Beaumont *Recruiting*
Royal Oak,  Michigan,  48073-6769
United States
Recruiting David  Decker 248-551-7695

Josephine Ford Cancer Center at Henry Ford Hospital *Recruiting*
Detroit,  Michigan,  48202
United States
Recruiting Robert  Chapman 313-916-1850

Veterans Affairs Medical Center - Chicago (Westside Hospital) *Recruiting*
Chicago,  Illinois,  60612
United States
Recruiting Thomas  Lad 312-996-2046

Veterans Affairs Medical Center - Biloxi *Recruiting*
Biloxi,  Mississippi,  39531-2410
United States
Recruiting Robert  Veith 504-568-5151

Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles,  California,  90095-1781
United States
Recruiting John  Barstis 310-825-5268

CCOP - Virginia Mason Research Center *Recruiting*
Seattle,  Washington,  98101
United States
Recruiting Andrew  Jacobs 206-341-0446

St. Louis University Hospital Cancer Center *Recruiting*
St. Louis,  Missouri,  63110
United States
Recruiting Paul  Petruska 314-577-8854

CCOP - Columbia River Oncology Program *Recruiting*
Portland,  Oregon,  97225
United States
Recruiting Keith  Lanier 503-216-6260

Veterans Affairs Medical Center - Lexington *Recruiting*
Lexington,  Kentucky,  40502-2236
United States
Recruiting Michael  Doukas 859-281-4956

University of Michigan Comprehensive Cancer Center *Recruiting*
Ann Arbor,  Michigan,  48109-0912
United States
Recruiting Laurence  Baker 734-936-3983

CCOP - Western Regional, Arizona *Recruiting*
Phoenix,  Arizona,  85006-2726
United States
Recruiting David  King 602-258-4875

Veterans Affairs Medical Center - Temple *Recruiting*
Temple,  Texas,  76504
United States
Recruiting Phalguni  Mukhopadhyay 254-778-4811 ext. 4809

Veterans Affairs Medical Center - Wichita *Recruiting*
Wichita,  Kansas,  67218
United States
Recruiting Shaker  Dakhil 316-685-2221

University of Arkansas for Medical Sciences *Recruiting*
Little Rock,  Arkansas,  72205
United States
Recruiting Laura  Hutchins 501-686-8511

USC/Norris Comprehensive Cancer Center and Hospital *Recruiting*
Los Angeles,  California,  90033
United States
Recruiting Heinz-Josef  Lenz 323-865-3955

Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) *Recruiting*
Hines,  Illinois,  60141
United States
Recruiting Nirmala  Bhoopalam 708-202-2782

CCOP - Southeast Cancer Control Consortium *Recruiting*
Winston Salem,  North Carolina,  27104-4241
United States
Recruiting James  Atkins 336-777-3036

David Grant Medical Center *Recruiting*
Travis Air Force Base,  California,  94535
United States
Recruiting David  Gandara 707-423-7300

Cancer Institute at Oregon Health and Science University *Recruiting*
Portland,  Oregon,  97201-3098
United States
Recruiting Craig  Nichols 503-494-6346

CCOP - Cancer Research for the Ozarks *Recruiting*
Springfield,  Missouri,  65807
United States
Recruiting John  Goodwin 417-269-4520

Veterans Affairs Medical Center - Salt Lake City *Recruiting*
Salt Lake City,  Utah,  84148
United States
Recruiting Wolfram  Samlowski 801-582-1565

Veterans Affairs Medical Center - Albany *Recruiting*
Albany,  New York,  12208
United States
Recruiting James  Holland 518-462-3311 ext. 2328

Charles M. Barrett Cancer Center at University Hospital *Recruiting*
Cincinnati,  Ohio,  45267-0501
United States
Recruiting Abdul-Rahman  Jazieh 513-584-3830

Louisiana State University Health Sciences Center - Shreveport *Recruiting*
Shreveport,  Louisiana,  71130-3932
United States
Recruiting Glenn  Mills 318-675-7639

Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center *Recruiting*
Orange,  California,  92868
United States
Recruiting Randall  Holcombe 714-456-5153

CCOP - St. Louis-Cape Girardeau *Recruiting*
St. Louis,  Missouri,  63141
United States
Recruiting Patrick  Henry 314-569-6573

CCOP - Kansas City *Recruiting*
Kansas City,  Missouri,  64131
United States
Recruiting Jorge  Paradelo 816-823-0555

CCOP - Scott and White Hospital *Recruiting*
Temple,  Texas,  76508
United States
Recruiting Lucas  Wong 254-724-7048

University of Texas - MD Anderson Cancer Center *Recruiting*
Houston,  Texas,  77030-4095
United States
Recruiting Scott  Lippman 713-745-3672

Veterans Affairs Medical Center - Shreveport *Recruiting*
Shreveport,  Louisiana,  71130
United States
Recruiting Glenn  Mills 318-221-8411

Veterans Affairs Medical Center - Portland *Recruiting*
Portland,  Oregon,  97207
United States
Recruiting Craig  Nichols 503-220-8262

Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) *Recruiting*
Phoenix,  Arizona,  85012
United States
Recruiting Thomas  Kummet 602-277-5551

CCOP - Santa Rosa Memorial Hospital *Recruiting*
Santa Rosa,  California,  95403
United States
Recruiting Ian  Anderson 707-521-3859

Danville Radiation Therapy Center *Recruiting*
Memphis,  Tennessee,  38104
United States
Recruiting Mohammad  Jahanzeb 901-523-8990

City of Hope Comprehensive Cancer Center *Recruiting*
Duarte,  California,  91010-0269
United States
Recruiting Kim  Margolin 626-359-8111

Markey Cancer Center at University of Kentucky Chandler Medical Center *Recruiting*
Lexington,  Kentucky,  40536-0084
United States
Recruiting Michael  Doukas 859-257-4500

CCOP - Upstate Carolina *Recruiting*
Spartanburg,  South Carolina,  29303
United States
Recruiting James  Bearden 864-560-7050

Barbara Ann Karmanos Cancer Institute *Recruiting*
Detroit,  Michigan,  48201-1379
United States
Recruiting Lawrence  Flaherty 313-745-9155

Oklahoma University Medical Center at University of Oklahoma Health Sciences Center *Recruiting*
Oklahoma City,  Oklahoma,  73104
United States
Recruiting Howard  Ozer 405-271-4022

Brooke Army Medical Center *Recruiting*
Fort Sam Houston,  Texas,  78234-6200
United States
Recruiting Mitchell  Garrison 210-916-0504

University of Texas Health Science Center at San Antonio *Recruiting*
San Antonio,  Texas,  78229-3900
United States
Recruiting Geoffrey  Weiss 210-617-5120

CCOP - Northwest *Recruiting*
Tacoma,  Washington,  98405-0986
United States
Recruiting Lauren  Colman 253-403-1461

Veterans Affairs Medical Center - Kansas City *Recruiting*
Kansas City,  Missouri,  64128
United States
Recruiting Sarah  Taylor 816-861-4700 ext. 491

Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland,  Ohio,  44195-9001
United States
Recruiting George  Budd 216-444-6480

University of Texas Medical Branch *Recruiting*
Galveston,  Texas,  77555-0565
United States
Recruiting Robert  Whitehead 409-772-1164

CCOP - Central Illinois *Recruiting*
Decatur,  Illinois,  62526
United States
Recruiting James  Wade 217-876-6617

Harrington Cancer Center *Recruiting*
Amarillo,  Texas,  79106
United States
Recruiting James  Clarkson 806-359-4673

CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor,  Michigan,  48106
United States
Recruiting Philip  Stella 734-712-2000

University of Tennessee Cancer Institute *Recruiting*
Memphis,  Tennessee,  38103
United States
Recruiting Mohammad  Jahanzeb 901-722-0532

Providence Cancer Institute at Providence Hospital *Recruiting*
Southfield,  Michigan,  48075
United States
Recruiting Anibal  Drelichman 313-552-0620

Veterans Affairs Medical Center - Dayton *Recruiting*
Dayton,  Ohio,  45428-1002
United States
Recruiting Howard  Gross 937-268-6511

CCOP - Montana Cancer Consortium *Recruiting*
Billings,  Montana,  59101
United States
Recruiting Patrick  Cobb 406-259-2245

Genesis Regional Cancer Center at Genesis Medical Center *Recruiting*
Davenport,  Iowa,  52804
United States
Recruiting George  Kovach 563-421-1908

CCOP - Wichita *Recruiting*
Wichita,  Kansas,  67214-3882
United States
Recruiting Shaker  Dakhil 316-268-5784

Veterans Affairs Medical Center - Seattle *Recruiting*
Seattle,  Washington,  98108
United States
Recruiting William  Schubach 206-764-2265

Kansas Cancer Institute at the University of Kansas Medical Center *Recruiting*
Kansas City,  Kansas,  66160-7353
United States
Recruiting Sarah  Taylor 913-588-6029

CCOP - Greenville *Recruiting*
Greenville,  South Carolina,  29615
United States
Recruiting Jeffrey  Giguere 864-241-6251

Herbert Irving Comprehensive Cancer Center at Columbia University *Recruiting*
New York City,  New York,  10032
United States
Recruiting Daniel  Petrylak 212-305-1731

Tulane University School of Medicine *Recruiting*
New Orleans,  Louisiana,  70112
United States
Recruiting Alan  Miller 504-587-7566

Cancer Research Center at Boston Medical Center *Recruiting*
Boston,  Massachusetts,  02118
United States
Recruiting Douglas  Faller 617-638-8000

Veterans Affairs Medical Center - Detroit *Recruiting*
Detroit,  Michigan,  48201-1932
United States
Recruiting Lawrence  Flaherty 313-576-1000

Veterans Affairs Medical Center - Amarillo *Recruiting*
Amarillo,  Texas,  79106
United States
Recruiting William  Robinson 806-355-9703

Arizona Cancer Center at University of Arizona Health Sciences Center *Recruiting*
Tucson,  Arizona,  85724
United States
Recruiting Thomas  Miller 520-626-2667

Veterans Affairs Medical Center - Cincinnati *Recruiting*
Cincinnati,  Ohio,  45220-2288
United States
Recruiting Abdul-Rahman  Jazieh 513-861-3100 ext. 6537

MBCCOP - Hawaii *Recruiting*
Honolulu,  Hawaii,  96813
United States
Recruiting Brian  Issell 808-586-3013

University of Colorado Cancer Center at University of Colorado Health Sciences Center *Recruiting*
Aurora,  Colorado,  80010
United States
Recruiting Anthony  Elias 720-848-1622

Veterans Affairs Medical Center - New Orleans *Recruiting*
New Orleans,  Louisiana,  70112
United States
Recruiting Alan  Miller 504-589-5250

Veterans Affairs Medical Center - Houston *Recruiting*
Houston,  Texas,  77030
United States
Recruiting Gauri  Varadhachary 713-791-1414 ext. 5340

Veterans Affairs Medical Center - Ann Arbor *Recruiting*
Ann Arbor,  Michigan,  48105
United States
Recruiting Laurence  Baker 734-769-7100

University of California Davis Cancer Center *Recruiting*
Sacramento,  California,  95817
United States
Recruiting David  Gandara 916-734-3772

MBCCOP - Massey Cancer Center *Recruiting*
Richmond,  Virginia,  23298-0037
United States
Recruiting John  Roberts 804-828-0450


Additional Information:
Study ID Numbers:
  CDR0000068656;  SWOG-S0001
Study Start Date: 
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00017147

Other Adult Glioblastoma Multiforme Studies:
1. Arsenic Trioxide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Malignant Glioma

2. Gefitinib Plus Temozolomide in Treating Patients With Malignant Primary Glioma

3. Talampanel and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

4. Combination Chemotherapy in Treating Patients With Recurrent Glioblastoma Multiforme

5. Carmustine Plus O6-benzylguanine in Treating Patients With Recurrent or Progressive Glioma

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Radiation Therapy and Carmustine With or Without O6-Benzylguanine in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma

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