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Dasatinib or Placebo, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase II, Phase IBiomarker/Laboratory analysis, TreatmentActive18 and overNCI, OtherCDR0000637854
NCCTG-N0877, N0877, NCT00869401

Trial Description

Summary

RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also make tumor cells more sensitive to radiation therapy. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This randomized phase I/II trial is studying the best dose of dasatinib and to see how well it works compared with a placebo when given together with radiation therapy and temozolomide in treating patients with newly diagnosed glioblastoma multiforme.

Further Study Information

OBJECTIVES:

  • To establish a maximum-tolerated dose of dasatinib combined with radiation and temozolomide in patients with newly diagnosed glioblastoma multiforme. (Phase I) (Phase I study closed to patient accrual on April 29, 2011 and has been completed)
  • To determine the efficacy of dasatinib in combination with radiotherapy and concomitant adjuvant temozolomide, and compare it with the standard of care approach, consisting of radiotherapy and temozolomide, followed by adjuvant temozolomide in these patients. (Phase II) (Phase II study opened to patient accrualon August 5, 2011)
  • To determine the relationship between tumor biomarkers and clinical outcome of patients treated with the dasatinib/radiotherapy/temozolomide combination. (Phase II)
  • To evaluate potential mechanisms of therapy resistance in recurrent tumor samples obtained at the time of surgery for recurrent disease.
  • To assess the impact of the addition of dasatinib to radiotherapy and temozolomide on the quality of life (QOL) of these patients, as assessed by FACT-Br, EORTC QLQ-C15-PAL, and EORTC QLQ-BN20. (Phase II)
  • To compare the results of the two most commonly used QOL tools, FACT-Br and EORTC QLQ C15-PAL plus BN20 and validate the use of EORTC QLQ-C15-PAL plus BN20 in these patients.(Phase II)

OUTLINE: This is a multicenter, phase I dose-escalation study of dasatinib (Phase I study closed to patient accrual on April 29, 2011 and has been completed) followed by a randomized phase II study (Phase II study opened to patient accrual on August 5, 2011).

  • Phase I:
  • Course 1: Patients receive oral dasatinib once daily and oral temozolomide once daily on days 1-42. Patients undergo external-beam radiotherapy (EBRT), including intensity-modulated radiotherapy, 5 days a week for 6 weeks.
  • Courses 2-7: Beginning 28-42 days after course 1, patients receive oral dasatinib once daily on days 1-28 and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
  • Phase II: Patients are stratified according to age (> 70 years vs ≤ 70 years). Patients are randomized to 1 of 2 treatment arms.
  • Arm I:
  • Course 1: Patients receive oral dasatinib once daily and oral temozolomide once daily on days 1-42. Patients undergo EBRT 5 days a week for 6 weeks.
  • Courses 2-7: Beginning 28-42 days after course 1, patients receive oral dasatinib once daily on days 1-28 and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II:
  • Course 1: Patients receive oral placebo once daily on days 1-42 and temozolomide as in arm I. Patients also undergo EBRT as in arm I.
  • Courses 2-7: Beginning 28-42 days after course 1, patients receive oral placebo once daily on days 1-28 and temozolomide as in arm I. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Tissue samples are collected for correlative studies.

Quality of life is assessed periodically using the FACT-Br, EORTC QLQ-C15-PAL v.1, and EORTC BN-20 questionnaires.

After completion of study therapy, patients are followed up every 6 months for 5 years.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed glioblastoma multiforme (GBM)
  • Grade 4 astrocytoma
  • No grade 4 oligoastrocytoma or GBM with oligodendroglial features
  • Newly diagnosed disease
  • Measurable or evaluable disease by gadolinium MRI or contrast CT scan
  • Patients who have had a gross total resection are eligible on the basis of evaluable disease
  • No pleural or pericardial effusion of any grade
  • No prior surgery for CNS neoplasms other than surgery related to the current GBM diagnosis
  • If Gliadel wafers are placed at time of primary resection this would be considered prior therapy and patient would be ineligible

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Absolute neutrophil count (ANC) ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin > 9.0 g/dL
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST ≤ 2.5 times ULN
  • Creatinine ≤ 1.5 times ULN
  • INR ≤ 1.5
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 12 weeks after completion of study treatment
  • No immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be HIV positive and currently receiving antiretroviral therapy
  • Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial
  • No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • No history of any of the following conditions:
  • Congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
  • Congenital long QT syndrome
  • Clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)
  • Prolonged QTc interval on pre-entry electrocardiogram (> 450 msec)
  • Hypokalemia or hypomagnesemia
  • Patients may not have any clinically significant cardiovascular disease including the following:
  • Myocardial infarction or ventricular tachyarrhythmia within 6 months
  • Ejection fraction less than institutional normal
  • Major conduction abnormality (unless a cardiac pacemaker is present)
  • New York Heart Association classification ≥ class II congestive heart failure
  • Patients with any cardiopulmonary symptoms of unknown cause (e.g., shortness of breath, chest pain, etc.) should be evaluated by a baseline echocardiogram with or without stress test as needed in addition to electrocardiogram (ECG) to rule out QTc prolongation
  • Patients with underlying cardiopulmonary dysfunction should be excluded from the study
  • No comorbid systemic illnesses or other severe concurrent disease that, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens including, but not limited to, any of the following:
  • History of bleeding diathesis
  • Concurrent chronic systemic anticoagulation therapy that can not be discontinued (i.e., antiplatelet agents or aspirin)
  • Concurrent t chronic nonsteroidal anti-inflammatory drugs (NSAIDs) that cannot be discontinued
  • No other active malignancy ≤ 5 years prior to registration
  • Exceptions: Non-melanotic skin cancer or carcinoma-in-situ of the cervix
  • If there is a history of prior malignancy, they must not be receiving other specific treatment (other than hormonal therapy) for their cancer
  • No severe allergy to sulfa medications and dapsone
  • Able to tolerate either intravenous or inhaled dapsone
  • Able to take oral medication
  • Willingness to abstain from eating grapefruit or drinking grapefruit juice for the duration of the study treatment

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • See Patient Characteristics
  • At least 5 days since prior and no concurrent St. John wort
  • No prior radiotherapy or chemotherapy for any CNS neoplasm (hormones, vitamins, and growth factors are not considered chemotherapy for the purposes of this study)
  • At least 7 days, but < 42 days, since prior stereotactic biopsy
  • At least 14 days, but < 42 days, since prior open craniotomy
  • Willing to forego other cytotoxic and non-cytotoxic drug therapy against the tumor while being treated with dasatinib and temozolomide
  • No other concurrent investigational agent considered as treatment for the primary neoplasm
  • Must not be currently taking any of the following medications:
  • Enzyme-inducing anticonvulsants (EIACs)
  • To be eligible, patient must be switched to non-EIAC medications ≥ 7 days prior to registration
  • Potent inhibitors of CYP3A4 that cannot be discontinued
  • Medications that may possibly prolong QT interval and produce a QTc that is ≥ 60 msec or a QTcF that is ≥ 450 msec
  • H2 blockers or proton pump inhibitors (PPIs), such as famotidine (Pepcid) and omeprazole (Prilosec) respectively, that cannot be discontinued or switched to locally acting agents, such as Maalox, Mylanta, or TUMS
  • No concurrent treatment immunosuppressive agent, except corticosteroids
  • No concurrent other anticancer agents
  • No concurrent prophylactic leukocyte growth factors (e.g., filgrastim [G-CSF] and sargramostim [GM-CSF])
  • No concurrent live vaccines
  • No concurrent therapeutic anticoagulation with warfarin
  • No concurrent ibuprofen or other nonsteroidal anti-inflammatory drugs (NSAIDs)

Trial Contact Information

Trial Lead Organizations/Sponsors

North Central Cancer Treatment Group

National Cancer Institute

Nadia N. LaackStudy Chair

Trial Sites

U.S.A.
Connecticut
  Hartford
 Helen and Harry Gray Cancer Center at Hartford Hospital
 Alexandra F Flowers Ph: 860-545-5363
Georgia
  Columbus
 John B. Amos Cancer Center
 Andrew W. Pippas Ph: 706-660-6404
Illinois
  Bloomington
 St. Joseph Medical Center
 John W. Kugler Ph: 800-793-2262
  Bloomington%
 Illinois CancerCare - Bloomington
 John W. Kugler Ph: 800-793-2262
  Canton
 Illinois CancerCare - Canton
 John W. Kugler Ph: 800-793-2262
  Carthage
 Illinois CancerCare - Carthage
 John W. Kugler Ph: 800-793-2262
  Chicago
 Creticos Cancer Center at Advocate Illinois Masonic Medical Center
 Deepti A. Singh Ph: 773-296-5360
 Resurrection Medical Center
 Christopher G. Rose Ph: 773-792-5116
  Eureka
 Eureka Community Hospital
 John W. Kugler Ph: 800-793-2262
 Illinois CancerCare - Eureka
 John W. Kugler Ph: 800-793-2262
  Havana
 Illinois CancerCare - Havana
 John W. Kugler Ph: 800-793-2262
  Kewanee
 Illinois CancerCare - Kewanee Clinic
 John W. Kugler Ph: 800-793-2262
  Macomb
 Illinois CancerCare - Macomb
 John W. Kugler Ph: 800-793-2262
  Monmouth
 Illinois CancerCare - Monmouth
 John W. Kugler Ph: 800-793-2262
 OSF Holy Family Medical Center
 John W. Kugler Ph: 800-793-2262
  Normal
 BroMenn Regional Medical Center
 John W. Kugler Ph: 800-793-2262
 Community Cancer Center
 John W. Kugler Ph: 800-793-2262
 Illinois CancerCare - Community Cancer Center
 John W. Kugler Ph: 800-793-2262
  Ottawa
 Community Hospital of Ottawa
 John W. Kugler Ph: 800-793-2262
 Illinois CancerCare - Ottawa
 John W. Kugler Ph: 800-793-2262
  Pekin
 Cancer Treatment Center at Pekin Hospital
 John W. Kugler Ph: 800-793-2262
 Illinois CancerCare - Pekin
 John W. Kugler Ph: 800-793-2262
  Peoria
 CCOP - Illinois Oncology Research Association
 John W. Kugler Ph: 800-793-2262
 Illinois CancerCare - Peoria
 John W. Kugler Ph: 800-793-2262
 Methodist Medical Center of Illinois
 John W. Kugler Ph: 800-793-2262
 OSF Saint Francis Medical Center Radiation Oncology Service at the Central Illinois Comprehensive CC
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 OSF St. Francis Medical Center
 John W. Kugler Ph: 800-793-2262
 Proctor Hospital
 John W. Kugler Ph: 800-793-2262
  Peru
 Illinois CancerCare - Princeton
 John W. Kugler Ph: 800-793-2262
 Illinois Valley Community Hospital
 John W. Kugler Ph: 800-793-2262
  Princeton
 Illinois CancerCare - Princeton
 John W. Kugler Ph: 800-793-2262
  Spring Valley
 Illinois CancerCare - Spring Valley
 John W. Kugler Ph: 800-793-2262
 Valley Cancer Center
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Urbana
 Carle Cancer Center at Carle Foundation Hospital
 Kalika P. Sarma Ph: 800-446-5532
Indiana
  Elkhart
 Elkhart Clinic, LLC
 Robin Zon Ph: 574-234-5123
 Elkhart General Hospital
 Robin Zon Ph: 574-234-5123
 Michiana Hematology-Oncology, PC - Elkhart
 Robin Zon Ph: 574-234-5123
  Indianapolis
 St. Francis Hospital Cancer Care Services
 Howard M. Gross Ph: 765-983-3000
  Kokomo
 Community Cancer Care at Howard Regional Health System
 Robin Zon Ph: 574-234-5123
  La Porte
 Center for Cancer Therapy at LaPorte Hospital and Health Services
 Robin Zon Ph: 574-234-5123
  Mishawaka
 Michiana Hematology-Oncology, PC - Mishawaka
 Robin Zon Ph: 574-234-5123
 Saint Joseph's Medical Center
 Robin Zon Ph: 574-234-5123
  Plymouth
 Michiana Hematology Oncology PC - Plymouth
 Robin Zon Ph: 574-234-5123
  Richmond
 Reid Hospital & Health Care Services
 Howard M. Gross Ph: 317-783-8918
  South Bend
 CCOP - Northern Indiana CR Consortium
 Robin Zon Ph: 574-234-5123
 Memorial Hospital of South Bend
 Robin Zon Ph: 574-234-5123
 Michiana Hematology-Oncology, PC - South Bend
 Robin Zon Ph: 574-234-5123
  Westville
 Michiana Hematology Oncology-PC Westville
 Robin Zon Ph: 574-234-5123
Iowa
  Cedar Rapids
 Cedar Rapids Oncology Associates
 Deborah W Wilbur Ph: 319-363-2690
 Deborah W Wilbur Ph: 319-363-2690
 Mercy Regional Cancer Center at Mercy Medical Center
 Deborah W Wilbur Ph: 319-363-2690
  Clive
 Medical Oncology and Hematology Associates-West Des Moines
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 Mercy Cancer Center - West Lakes
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
  Des Moines
 CCOP - Iowa Oncology Research Association
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 John Stoddard Cancer Center at Iowa Lutheran Hospital
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 John Stoddard Cancer Center at Iowa Methodist Medical Center
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 Medical Oncology and Hematology Associates at John Stoddard Cancer Center
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 Medical Oncology and Hematology Associates at Mercy Cancer Center
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 Mercy Cancer Center at Mercy Medical Center - Des Moines
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
  Sioux City
 Mercy Medical Center - Sioux City
 Donald Bruce Wender Ph: 712-252-0088
 Siouxland Hematology-Oncology Associates, LLP
 Donald Bruce Wender Ph: 712-252-0088
 St. Luke's Regional Medical Center
 Donald Bruce Wender Ph: 712-252-0088
  West Des Moines
 Methodist West Hospital
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
Kansas
  Chanute
 Cancer Center of Kansas, PA - Chanute
 Shaker R. Dakhil Ph: 316-262-4467
  Dodge City
 Cancer Center of Kansas, PA - Dodge City
 Shaker R. Dakhil Ph: 316-262-4467
  El Dorado
 Cancer Center of Kansas, PA - El Dorado
 Shaker R. Dakhil Ph: 316-262-4467
  Fort Scott
 Cancer Center of Kansas - Fort Scott
 Shaker R. Dakhil Ph: 316-262-4467
  Independence
 Cancer Center of Kansas-Independence
 Shaker R. Dakhil Ph: 316-262-4467
  Kingman
 Cancer Center of Kansas, PA - Kingman
 Shaker R. Dakhil Ph: 316-262-4467
  Lawrence
 Lawrence Memorial Hospital
 Shaker R. Dakhil Ph: 316-262-4467
  Liberal
 Cancer Center of Kansas, PA - Liberal
 Shaker R. Dakhil Ph: 316-262-4467
  Newton
 Cancer Center of Kansas, PA - Newton
 Shaker R. Dakhil Ph: 316-262-4467
  Parsons
 Cancer Center of Kansas, PA - Parsons
 Shaker R. Dakhil Ph: 316-262-4467
  Pratt
 Cancer Center of Kansas, PA - Pratt
 Shaker R. Dakhil Ph: 316-262-4467
  Salina
 Cancer Center of Kansas, PA - Salina
 Shaker R. Dakhil Ph: 316-262-4467
  Wellington
 Cancer Center of Kansas, PA - Wellington
 Shaker R. Dakhil Ph: 316-262-4467
  Wichita
 Associates in Women's Health, PA - North Hillside
 Shaker R. Dakhil Ph: 316-262-4467
 Cancer Center of Kansas, PA - Medical Arts Tower
 Shaker R. Dakhil Ph: 316-262-4467
 Cancer Center of Kansas, PA - Wichita
 Shaker R. Dakhil Ph: 316-262-4467
 CCOP - Wichita
 Shaker R. Dakhil Ph: 316-262-4467
 Via Christi Cancer Center at Via Christi Regional Medical Center
 Shaker R. Dakhil Ph: 316-262-4467
 Wesley Medical Center
 Shaker R. Dakhil Ph: 316-262-4467
  Winfield
 Cancer Center of Kansas, PA - Winfield
 Shaker R. Dakhil Ph: 316-262-4467
Michigan
  Adrian
 Hickman Cancer Center at Bixby Medical Center
 Rex B Mowat Ph: 517-265-0116
 Rex B Mowat Ph: 517-265-0116
  Monroe
 Community Cancer Center of Monroe
 Rex B Mowat Ph: 517-265-0116
 Mercy Memorial Hospital - Monroe
 Rex B Mowat Ph: 517-265-0116
  Saint Joseph
 Lakeside Cancer Specialists, PLLC
 Robin Zon Ph: 574-234-5123
  St. Joseph
 Lakeland Regional Cancer Care Center - St. Joseph
 Robin Zon Ph: 574-234-5123
Minnesota
  Bemidji
 MeritCare Bemidji
 Preston D. Steen Ph: 701-234-6161
  Burnsville
 Fairview Ridges Hospital
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Coon Rapids
 Mercy and Unity Cancer Center at Mercy Hospital
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Duluth
 CCOP - Duluth
 Bret E Friday Ph: 888-203-7267
 Essentia Health - Duluth Clinic
 Bret E Friday Ph: 888-203-7267
 Miller - Dwan Medical Center
 Bret E Friday Ph: 888-203-7267
  Edina
 Fairview Southdale Hospital
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Fridley
 Mercy and Unity Cancer Center at Unity Hospital
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Hutchinson
 Hutchinson Area Health Care
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Maplewood
 HealthEast Cancer Care at St. John's Hospital
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Minnesota Oncology - Maplewood
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Minneapolis
 Hennepin County Medical Center - Minneapolis
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Robbinsdale
 Humphrey Cancer Center at North Memorial Outpatient Center
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Rochester
 Mayo Clinic Cancer Center
 Nadia N Laack Ph: 507-538-7623
 North Central Cancer Treatment Group
 Nadia N Laack Ph: 507-284-3559
  Email: laack.nadia@mayo.edu
  Saint Cloud
 CentraCare Clinic - Women and Children
 Donald J Jurgens Ph: 877-229-4907
  Email: coborncancercenter@centracare.com
 Coborn Cancer Center
 Donald J Jurgens Ph: 877-229-4907
  Email: coborncancercenter@centracare.com
  Saint Louis Park
 CCOP - Metro-Minnesota
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Park Nicollet Cancer Center
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Saint Paul
 Regions Hospital Cancer Care Center
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 United Hospital
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Shakopee
 St. Francis Cancer Center at St. Francis Medical Center
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Stillwater
 Lakeview Hospital
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Waconia
 Ridgeview Medical Center
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Willmar
 Willmar Cancer Center at Rice Memorial Hospital
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Woodbury
 Minnesota Oncology - Woodbury
 Daniel M Anderson Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
Missouri
  Saint Louis
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 David D Tran Ph: 800-600-3606
  Email: info@siteman.wustl.edu
Montana
  Billings
 Billings Clinic Cancer Center - 801 N 29th Street
 Benjamin Thomas Marchello Ph: 800-648-6274
 CCOP - Montana Cancer Consortium
 Benjamin Thomas Marchello Ph: 800-648-6274
 Hematology-Oncology Centers of the Northern Rockies - Billings
 Benjamin Thomas Marchello Ph: 800-648-6274
 St. Vincent Healthcare Cancer Care Services
 Benjamin Thomas Marchello Ph: 800-648-6274
  Bozeman
 Bozeman Deaconess Cancer Center
 Benjamin Thomas Marchello Ph: 800-648-6274
  Butte
 St. James Healthcare Cancer Care
 Benjamin Thomas Marchello Ph: 800-648-6274
  Great Falls
 Benefis Sletten Cancer Institute
 Benjamin Thomas Marchello Ph: 800-648-6274
  Helena
 St. Peter's Hospital
 Benjamin Thomas Marchello Ph: 800-648-6274
  Kalispell
 Kalispell Regional Medical Center
 Benjamin Thomas Marchello Ph: 800-648-6274
  Missoula
 Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
 Benjamin Thomas Marchello Ph: 800-648-6274
 Montana Cancer Specialists at Montana Cancer Center
 Benjamin Thomas Marchello Ph: 800-648-6274
New Hampshire
  Concord
 New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
 Douglas Jay Weckstein Ph: 603-224-2556
  Hooksett
 New Hampshire Oncology - Hematology, PA - Hooksett
 Douglas Jay Weckstein Ph: 603-224-2556
  Laconia
 Lakes Region General Hospital
 Douglas Jay Weckstein Ph: 603-224-2556
New Mexico
  Albuquerque
 University of New Mexico Cancer Center
 Fa-Chyi Lee Ph: 505-727-8000
New York
  East Syracuse
 CCOP - Hematology-Oncology Associates of Central New York
 Jeffrey J. Kirshner Ph: 315-472-7504
North Carolina
  Asheville
 Mission Hospitals - Memorial Campus
 Christopher H Chay Ph: 828-213-4150
  Goldsboro
 Wayne Memorial Hospital, Incorporated
 James N. Atkins Ph: 919-580-0000
North Dakota
  Bismarck
 Medcenter One Hospital Cancer Care Center
 John T Reynolds Ph: 701-323-5760
  Email: tfischer@mohs.org
 Mid Dakota Clinic, PC
 John T Reynolds Ph: 701-323-5760
  Email: tfischer@mohs.org
 St. Alexius Medical Center Cancer Center
 John T Reynolds Ph: 701-323-5760
  Email: tfischer@mohs.org
  Fargo
 Sanford Clinic North-Fargo
 Preston D. Steen Ph: 701-234-6161
  Grand Forks
 Altru Cancer Center at Altru Hospital
 Grant R Seeger Ph: 701-780-6520
Ohio
  Bowling Green
 Wood County Oncology Center
 Rex B Mowat Ph: 517-265-0116
  Chillicothe
 Adena Regional Medical Center
 J. Philip Kuebler Ph: 614-566-3275
  Cincinnati
 University of Cincinnati
 Howard M. Gross Ph: 317-783-8918
  Columbus
 CCOP - Columbus
 J. Philip Kuebler Ph: 614-566-3275
 Doctors Hospital at Ohio Health
 J. Philip Kuebler Ph: 614-566-3275
 Grant Medical Center Cancer Care
 J. Philip Kuebler Ph: 614-566-3275
 Mount Carmel Health - West Hospital
 J. Philip Kuebler Ph: 614-566-3275
 Riverside Methodist Hospital Cancer Care
 J. Philip Kuebler Ph: 614-566-3275
  Dayton
 CCOP - Dayton
 Howard M. Gross Ph: 317-783-8918
 David L. Rike Cancer Center at Miami Valley Hospital
 Howard M. Gross Ph: 317-783-8918
 Good Samaritan Hospital
 Howard M. Gross Ph: 317-783-8918
 Grandview Hospital
 Howard M. Gross Ph: 317-783-8918
 Samaritan North Cancer Care Center
 Howard M. Gross Ph: 317-783-8918
  Delaware
 Grady Memorial Hospital
 J. Philip Kuebler Ph: 614-566-3275
  Elyria
 Hematology Oncology Center
 Rex B Mowat Ph: 517-265-0116
 Mercy Cancer Center - Elyria
 Rex B Mowat Ph: 517-265-0116
  Findlay
 Blanchard Valley Regional Cancer Center
 Howard M. Gross Ph: 317-783-8918
  Franklin
 Atrium Medical Center
 Howard M. Gross Ph: 317-783-8918
  Greenville
 Wayne Hospital
 Howard M. Gross Ph: 317-783-8918
  Kettering
 Charles F. Kettering Memorial Hospital
 Howard M. Gross Ph: 317-783-8918
  Lancaster
 Fairfield Medical Center
 J. Philip Kuebler Ph: 614-566-3275
  Lima
 Lima Memorial Hospital
 Rex B Mowat Ph: 517-265-0116
  Marietta
 Strecker Cancer Center at Marietta Memorial Hospital
 J. Philip Kuebler Ph: 614-566-3275
  Maumee
 Northwest Ohio Oncology Center
 Rex B Mowat Ph: 517-265-0116
 Rex B Mowat Ph: 517-265-0116
  Mount Vernon
 Knox Community Hospital
 J. Philip Kuebler Ph: 614-566-3275
  Newark
 Licking Memorial Cancer Care Program at Licking Memorial Hospital
 J. Philip Kuebler Ph: 614-566-3275
  Oregon
 St. Charles Mercy Hospital
 Rex B Mowat Ph: 517-265-0116
 Toledo Clinic - Oregon
 Rex B Mowat Ph: 517-265-0116
  Portsmouth
 Southern Ohio Medical Center Cancer Center
 J. Philip Kuebler Ph: 614-566-3275
  Springfield
 Community Hospital of Springfield and Clark County
 J. Philip Kuebler Ph: 614-566-3275
  Sylvania
 Flower Hospital Cancer Center
 Rex B Mowat Ph: 517-265-0116
  Tiffin
 Mercy Hospital of Tiffin
 Rex B Mowat Ph: 517-265-0116
  Toledo
 St. Anne Mercy Hospital
 Rex B Mowat Ph: 517-265-0116
 St. Vincent Mercy Medical Center
 Rex B Mowat Ph: 517-265-0116
 Toledo Clinic, Incorporated - Main Clinic
 Rex B Mowat Ph: 517-265-0116
 Toledo Hospital
 Rex B Mowat Ph: 517-265-0116
 University of Toledo Medical Center
 Rex B Mowat Ph: 517-265-0116
  Troy
 UVMC Cancer Care Center at Upper Valley Medical Center
 Howard M. Gross Ph: 317-783-8918
  Wauseon
 Fulton County Health Center
 Rex B Mowat Ph: 517-265-0116
  West Chester
 University Pointe
 Howard M. Gross Ph: 317-783-8918
  Westerville
 Mount Carmel St. Ann's Cancer Center
 J. Philip Kuebler Ph: 614-566-3275
  Xenia
 Ruth G. McMillan Cancer Center at Greene Memorial Hospital
 Howard M. Gross Ph: 317-783-8918
  Zanesville
 Genesis - Good Samaritan Hospital
 J. Philip Kuebler Ph: 614-566-3275
Oklahoma
  Tulsa
 Natalie Warren Bryant Cancer Center at St. Francis Hospital
 Alan M Keller Ph: 918-499-2000
Pennsylvania
  Allentown
 Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
 Suresh G. Nair Ph: 610-402-2273
South Carolina
  Easley
 Cancer Centers of the Carolinas - Easley
 David L Grisell Ph: 864-241-6251
  Greenville
 Cancer Centers of the Carolinas - Andrews
 David L Grisell Ph: 864-241-6251
 Cancer Centers of the Carolinas - Faris Road
 David L Grisell Ph: 864-241-6251
 Cancer Centers of the Carolinas - Grove Commons
 David L Grisell Ph: 864-241-6251
 CCOP - Greenville
 David L Grisell Ph: 864-241-6251
 Greenville Memorial Hospital
 David L Grisell Ph: 864-241-6251
  Greer
 Cancer Centers of the Carolinas - Greer Medical Oncology
 David L Grisell Ph: 864-241-6251
 Cancer Centers of the Carolinas - Greer Radiation Oncology
 David L Grisell Ph: 864-241-6251
  Seneca
 Cancer Centers of the Carolinas - Seneca
 David L Grisell Ph: 864-241-6251
  Spartanburg
 Cancer Centers of the Carolinas - Spartanburg
 David L Grisell Ph: 864-241-6251
South Dakota
  Rapid City
 Rapid City Regional Hospital
 Mark T Schroeder Ph: 605-716-3982
  Email: research@rcrh.org
  Sioux Falls
 Avera Cancer Institute
 Addison R Tolentino Ph: 800-657-4377
  Email: Jan.Healy@avera.org
 Sanford Cancer Center at Sanford USD Medical Center
 Miroslaw A Mazurczak Ph: 605-328-1367
 Miroslaw A Mazurczak Ph: 605-328-1367
Virginia
  Fredericksburg
 Fredericksburg Oncology Inc
 Rex B Mowat Ph: 517-265-0116
Wisconsin
  Eau Claire
 Center for Cancer Treatment & Prevention at Sacred Heart Hospital
 Benjamin E. Lawler Ph: 715-389-4457
 Marshfield Clinic Cancer Care at Regional Cancer Center
 Benjamin E. Lawler Ph: 715-389-4457
  Fond Du Lac
 Central Wisconsin Cancer Program at Agnesian HealthCare
 Timothy P Korytko Ph: 800-494-2927
  La Crosse
 Gundersen Lutheran Center for Cancer and Blood
 Kurt Oettel Ph: 608-775-2385
  Email: cancerctr@gundluth.org
  Marshfield
 Marshfield Clinic - Marshfield Center
 Benjamin E. Lawler Ph: 715-389-4457
 Saint Joseph's Hospital
 Benjamin E. Lawler Ph: 715-389-4457
  Minocqua
 Marshfield Clinic - Lakeland Center
 Benjamin E. Lawler Ph: 715-389-4457
  Rhinelander
 Ministry Medical Group at Saint Mary's Hospital
 Benjamin E. Lawler Ph: 715-389-4457
  Rice Lake
 Marshfield Clinic - Indianhead Center
 Benjamin E. Lawler Ph: 715-389-4457
  Stevens Point
 Marshfield Clinic at Saint Michael's Hospital
 Benjamin E. Lawler Ph: 715-389-4457
 Saint Michael's Hospital Cancer Center
 Benjamin E. Lawler Ph: 715-389-4457
  Weston
 Marshfield Clinic - Weston Center
 Benjamin E. Lawler Ph: 715-389-4457

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00869401
Information obtained from ClinicalTrials.gov on February 21, 2013

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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