
Vorinostat and Bortezomib in Treating Patients With Progressive, Recurrent Glioblastoma Multiforme
Study Purpose
This phase II trial is studying how well giving vorinostat together with bortezomib works in treating patients with progressive, recurrent glioblastoma multiforme. Vorinostat and bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vorinostat together with bortezomib may kill more tumor cells.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
Inclusion Criteria:
- - Histologically confirmed glioblastoma multiforme.
- - Gliosarcoma or other grade 4 astrocytoma variant (e.g., giant cell glioblastoma) allowed.
- - Recurrent disease.
- - Must have evidence of tumor progression by MRI or CT scan after radiotherapy or after the most recent antitumor therapy.
- - Bidimensionally measurable or evaluable disease by MRI or CT scan.
- - Patients receiving corticosteroids must be on a fixed dose for at least 1 week prior to baseline scan.
- - ECOG performance status 0-2.
- - WBC ≥ 3,000/mm³ - ANC ≥ 1,500/mm³ - Platelet count ≥ 100,000/mm³ - Hemoglobin ≥ 9 g/dL.
- - Total bilirubin ≤ 1.5 times upper limit of normal (ULN) - AST ≤ 3 times ULN.
- - Creatinine normal.
- - Not pregnant or nursing.
- - Negative pregnancy test.
- - Fertile patients must use effective contraception during and for 6 months after the last dose of vorinostat.
- - Willing to provide mandatory correlative laboratory tissue samples.
- - Able to take oral medications.
- - No uncontrolled infection.
- - No known hypersensitivity to any of the components of vorinostat or bortezomib.
- - No myocardial infarction or unstable angina within the past 6 months.
- - No congestive heart failure requiring use of ongoing maintenance therapy or history of life-threatening ventricular arrhythmias.
- - No concurrent uncontrolled illness including, but not limited to, any of the following: - Ongoing or active infection.
- - Psychiatric illness or social situation that would limit compliance with study requirements.
- - No other active malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix.
- - No comorbid systemic illness or other severe concurrent disease that, in the judgment of the investigator, would preclude study entry or significantly interfere with proper assessment of safety and toxicity of the prescribed study regimens.
- - Not immunocompromised.
- - Patients known to be HIV positive are eligible provided there is no clinical evidence of an immunocompromised state.
- - No peripheral neuropathy ≥ grade 2.
- - No peripheral neuropathy with pain ≥ grade 1.
- - No congenital long QT syndrome.
- - No prolonged OTC interval (> 450 msec) - No other concurrent anticancer therapy (other than hormonal therapy) - At least 8 weeks since prior radiotherapy.
- - More than 6 weeks since prior stereotactic radiosurgery or interstitial brachytherapy, unless there is a separate lesion on MRI that is not part of the prior treatment field.
- - More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) - No more than 1 prior chemotherapy regimen* for progressive/recurrent disease (stratum 1) - Patients in stratum 2 may have received any number of prior chemotherapy regimens* for progressive/recurrent disease.
- - More than 2 weeks since prior small molecule cell cycle inhibitors.
- - More than 7 days since prior valproic acid.
- - More than 7 days since prior category I drugs that are generally accepted to have a risk of causing Torsades de Pointes including: - Quinidine, procainamide, disopyramide.
- - Amiodarone, sotalol, ibutilide, dofetilide.
- - Erythromycin, clarithromycin.
- - Chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide.
- - Cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin,lidoflazine.
- - More than 4 weeks since prior bevacizumab.
- - No prior treatment with vorinostat or bortezomib.
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT00641706 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 2 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
National Cancer Institute (NCI) |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Evanthia Galanis |
Principal Investigator Affiliation | North Central Cancer Treatment Group |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
NIH |
Overall Status | Completed |
Countries | United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Tumor |
PRIMARY OBJECTIVES:
- I. To determine the clinical efficacy of vorinostat (SAHA) and bortezomib, in terms of progression-free survival (PFS) at 6 months, in patients with progressive, recurrent glioblastoma multiforme.
- I. To determine the clinical efficacy of this regimen, in terms of overall survival, PFS at 12 months, time to progression, and objective response rate, in these patients.
- II. To identify molecular predictors of response in baseline tumor specimens from these patients.
- III. To determine molecular changes in response to this regimen in tumor specimens from patients undergoing surgery.
Arms
Experimental: Stratum 1 (not undergoing surgery)
Patients receive oral vorinostat (SAHA) once daily on days 1-14 and bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Experimental: Stratum 2 (undergoing surgery)
Patients receive oral SAHA once daily for 2 days prior to surgery and then on the day of surgery. Patients also receive bortezomib IV on the day of surgery. After receiving the 3rd dose of SAHA, patients undergo surgery to remove the tumor. Beginning at least 7 days after surgery, patients receive SAHA and bortezomib as in stratum 1.
Interventions
Drug: - vorinostat
Given orally
Procedure: - therapeutic conventional surgery
Patient undergoes surgery
Drug: - bortezomib
Given IV
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Address
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
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The Medical Center of Aurora
Aurora, Colorado, 80012
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Boulder Community Hospital
Boulder, Colorado, 80301
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Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907
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Porter Adventist Hospital
Denver, Colorado, 80210
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Exempla Saint Joseph Hospital
Denver, Colorado, 80218
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Address
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, 80218
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Rose Medical Center
Denver, Colorado, 80220
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Colorado Cancer Research Program CCOP
Denver, Colorado, 80224-2522
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Swedish Medical Center
Englewood, Colorado, 80113
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Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, 81502
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North Colorado Medical Center
Greeley, Colorado, 80631
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Saint Anthony Hospital
Lakewood, Colorado, 80228
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Sky Ridge Medical Center
Lone Tree, Colorado, 80124
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Longmont United Hospital
Longmont, Colorado, 80501
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McKee Medical Center
Loveland, Colorado, 80539
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Saint Mary Corwin Medical Center
Pueblo, Colorado, 81004
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North Suburban Medical Center
Thornton, Colorado, 80229
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Exempla Lutheran Medical Center
Wheat Ridge, Colorado, 80033
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Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
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Rush - Copley Medical Center
Aurora, Illinois, 60504
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Address
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61701
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Address
Saint Joseph Medical Center
Bloomington, Illinois, 61701
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Address
Graham Hospital Association
Canton, Illinois, 61520
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Address
Illinois CancerCare-Canton
Canton, Illinois, 61520
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Address
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
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Address
Memorial Hospital
Carthage, Illinois, 62321
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Address
Eureka Hospital
Eureka, Illinois, 61530
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Address
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
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Address
Galesburg Cottage Hospital
Galesburg, Illinois, 61401
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Address
Illinois CancerCare Galesburg
Galesburg, Illinois, 61401
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Address
Illinois CancerCare-Cottage
Galesburg, Illinois, 61401
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Address
Illinois CancerCare-Havana
Havana, Illinois, 62644
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Address
Mason District Hospital
Havana, Illinois, 62644
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Address
Hopedale Medical Complex - Hospital
Hopedale, Illinois, 61747
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Address
Joliet Oncology-Hematology Associates Limited
Joliet, Illinois, 60435
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Address
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443
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Address
Illinois CancerCare-Macomb
Macomb, Illinois, 61455
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Address
Mcdonough District Hospital
Macomb, Illinois, 61455
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Address
Garneau, Stewart C MD (UIA Investigator)
Moline, Illinois, 61265
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Address
Porubcin, Michael MD (UIA Investigator)
Moline, Illinois, 61265
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Address
Sharis, Christine M MD (UIA Investigator)
Moline, Illinois, 61265
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Address
Stoffel, Thomas J MD (UIA Investigator)
Moline, Illinois, 61265
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Address
Holy Family Medical Center
Monmouth, Illinois, 61462
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Address
Illinois CancerCare-Monmouth
Monmouth, Illinois, 61462
Status
Address
Bromenn Regional Medical Center
Normal, Illinois, 61761
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Address
Community Cancer Center Foundation
Normal, Illinois, 61761
Status
Address
Illinois CancerCare-Community Cancer Center
Normal, Illinois, 61761
Status
Address
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350
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Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, 61350
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Address
Pekin Cancer Treatment Center
Pekin, Illinois, 61554
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Address
Pekin Hospital
Pekin, Illinois, 61554
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Address
Illinois CancerCare-Pekin
Pekin, Illinois, 61603
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Address
Methodist Medical Center of Illinois
Peoria, Illinois, 61603
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Address
Proctor Hospital
Peoria, Illinois, 61614
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Address
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
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Address
Illinois Oncology Research Association CCOP
Peoria, Illinois, 61615
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Address
OSF Saint Francis Medical Center
Peoria, Illinois, 61637
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Address
Illinois CancerCare-Peru
Peru, Illinois, 61354
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Address
Illinois Valley Hospital
Peru, Illinois, 61354
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Address
Illinois CancerCare-Princeton
Princeton, Illinois, 61356
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Address
Perry Memorial Hospital
Princeton, Illinois, 61356
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Address
Illinois CancerCare-Spring Valley
Spring Valley, Illinois, 61362
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Address
Saint Margaret's Hospital
Spring Valley, Illinois, 61362
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Address
Carle Cancer Center
Urbana, Illinois, 61801
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Address
Carle Clinic-Urbana Main
Urbana, Illinois, 61801
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Address
Saint Francis Hospital and Health Centers
Beech Grove, Indiana, 46107
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Address
Elkhart General Hospital
Elkhart, Indiana, 46515
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Address
Community Howard Regional Health
Kokomo, Indiana, 46904
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Address
IU Health La Porte Hospital
La Porte, Indiana, 46350
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Address
Franciscan Saint Anthony Health-Michigan City
Michigan City, Indiana, 46360
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Address
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, 46545-1470
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Address
Reid Hospital and Health Care Services
Richmond, Indiana, 47374
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Address
Memorial Hospital of South Bend
South Bend, Indiana, 46601
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Address
South Bend Clinic
South Bend, Indiana, 46617
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Address
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46628
Status
Address
Constantinou, Costas L MD (UIA Investigator)
Bettendorf, Iowa, 52722
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Address
Cedar Rapids Oncology Association
Cedar Rapids, Iowa, 52403
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Address
Mercy Hospital
Cedar Rapids, Iowa, 52403
Status
Address
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403
Status
Address
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, 50325
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Address
Mercy Capitol
Des Moines, Iowa, 50307
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Address
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
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Address
Iowa Oncology Research Association CCOP
Des Moines, Iowa, 50309
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Address
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, 50309
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Address
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, 50314
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Address
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
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Address
Iowa Lutheran Hospital
Des Moines, Iowa, 50316
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Address
Siouxland Hematology Oncology Associates
Sioux City, Iowa, 51101
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Address
Mercy Medical Center-Sioux City
Sioux City, Iowa, 51104
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Address
Saint Luke's Regional Medical Center
Sioux City, Iowa, 51104
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Address
Hospital District Sixth of Harper County
Anthony, Kansas, 67003
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Address
Bixby Medical Center
Adrian, Michigan, 49221
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Address
Hickman Cancer Center
Adrian, Michigan, 49221
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Address
Bronson Battle Creek
Battle Creek, Michigan, 49017
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Address
Spectrum Health Big Rapids Hospital
Big Rapids, Michigan, 49307
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Address
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, 49503
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Address
Mercy Health Saint Mary's
Grand Rapids, Michigan, 49503
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Address
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503
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Address
Community Cancer Center of Monroe
Monroe, Michigan, 48162
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Address
Mercy Memorial Hospital
Monroe, Michigan, 48162
Status
Address
Mercy Health Partners-Hackley Campus
Muskegon, Michigan, 49442
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Address
Mercy Health Mercy Campus
Muskegon, Michigan, 49444
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Address
Lakeland Hospital
St. Joseph, Michigan, 49085
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Address
Munson Medical Center
Traverse City, Michigan, 49684
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Address
Metro Health Hospital
Wyoming, Michigan, 49519
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Address
Sanford Clinic North-Bemidgi
Bemidji, Minnesota, 56601
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Address
Fairview Ridges Hospital
Burnsville, Minnesota, 55337
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Address
Mercy Hospital
Coon Rapids, Minnesota, 55433
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Address
Essentia Health Duluth Clinic CCOP
Duluth, Minnesota, 55805
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Address
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, 55805
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Address
Miller-Dwan Hospital
Duluth, Minnesota, 55805
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Address
Fairview-Southdale Hospital
Edina, Minnesota, 55435
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Address
Lake Region Healthcare Corporation-Cancer Care
Fergus Falls, Minnesota, 56537
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Address
Unity Hospital
Fridley, Minnesota, 55432
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Address
Hutchinson Area Health Care
Hutchinson, Minnesota, 55350
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Address
Meeker County Memorial Hospital
Litchfield, Minnesota, 55355
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Address
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109
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Address
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109
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Address
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407
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Address
Virginia Piper Cancer Institute
Minneapolis, Minnesota, 55407
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Address
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
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Address
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422
Status
Address
Mayo Clinic
Rochester, Minnesota, 55905
Status
Address
Metro-Minnesota CCOP
Saint Louis Park, Minnesota, 55416
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Address
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416
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Address
Regions Hospital
Saint Paul, Minnesota, 55101
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Address
United Hospital
Saint Paul, Minnesota, 55102
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Address
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379
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Address
Ridgeview Medical Center
Waconia, Minnesota, 55387
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Address
Minnesota Oncology and Hematology PA-Woodbury
Woodbury, Minnesota, 55125
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Address
Montana Cancer Consortium CCOP
Billings, Montana, 59101
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Address
Northern Rockies Radiation Oncology Center
Billings, Montana, 59101
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Address
Saint Vincent Healthcare
Billings, Montana, 59101
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Address
Hematology-Oncology Centers of the Northern Rockies PC
Billings, Montana, 59102
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Address
Billings Clinic
Billings, Montana, 59107-7000
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Address
Bozeman Deaconess Cancer Center
Bozeman, Montana, 59715
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Address
Bozeman Deaconess Hospital
Bozeman, Montana, 59715
Status
Address
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, 59701
Status
Address
Berdeaux, Donald MD (UIA Investigator)
Great Falls, Montana, 59405
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Address
Great Falls Clinic
Great Falls, Montana, 59405
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Address
Northern Montana Hospital
Havre, Montana, 59501
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Address
Saint Peter's Community Hospital
Helena, Montana, 59601
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Address
Glacier Oncology PLLC
Kalispell, Montana, 59901
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Address
Kalispell Medical Oncology
Kalispell, Montana, 59901
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Address
Kalispell Regional Medical Center
Kalispell, Montana, 59901
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Address
Community Medical Hospital
Missoula, Montana, 59801
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Address
Montana Cancer Specialists
Missoula, Montana, 59802
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Address
Saint Patrick Hospital - Community Hospital
Missoula, Montana, 59802
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Address
Guardian Oncology and Center for Wellness
Missoula, Montana, 59804
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Address
Rutherford Hospital
Rutherfordton, North Carolina, 28139
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Address
Bismarck Cancer Center
Bismarck, North Dakota, 58501
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Address
Mid Dakota Clinic
Bismarck, North Dakota, 58501
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Address
Saint Alexius Medical Center
Bismarck, North Dakota, 58501
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Address
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501
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Address
Sanford Clinic North-Fargo
Fargo, North Dakota, 58122
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Address
Sanford Medical Center-Fargo
Fargo, North Dakota, 58122
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Address
Altru Cancer Center
Grand Forks, North Dakota, 58201
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Address
Mary Rutan Hospital
Bellefontaine, Ohio, 43311
Status
Address
Toledo Clinic Cancer Centers-Bowling Green
Bowling Green, Ohio, 43402
Status
Address
North Coast Cancer Care-Clyde
Clyde, Ohio, 43410
Status
Address
Riverside Methodist Hospital
Columbus, Ohio, 43214
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Address
Grant Medical Center
Columbus, Ohio, 43215
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Address
Mount Carmel Health Center West
Columbus, Ohio, 43222
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Address
Doctors Hospital
Columbus, Ohio, 43228
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Address
Grandview Hospital
Dayton, Ohio, 45405
Status
Address
Good Samaritan Hospital - Dayton
Dayton, Ohio, 45406
Status
Address
Miami Valley Hospital
Dayton, Ohio, 45409
Status
Address
Samaritan North Health Center
Dayton, Ohio, 45415
Status
Address
Dayton CCOP
Dayton, Ohio, 45420
Status
Address
Grady Memorial Hospital
Delaware, Ohio, 43015
Status
Address
Hematology Oncology Center Incorporated
Elyria, Ohio, 44035
Status
Address
Blanchard Valley Hospital
Findlay, Ohio, 45840
Status
Address
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066
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Address
Wayne Hospital
Greenville, Ohio, 45331
Status
Address
Kettering Medical Center
Kettering, Ohio, 45429
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Address
Fairfield Medical Center
Lancaster, Ohio, 43130
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Address
Lima Memorial Hospital
Lima, Ohio, 45804
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Address
Marietta Memorial Hospital
Marietta, Ohio, 45750
Status
Address
Saint Luke's Hospital
Maumee, Ohio, 43537
Status
Address
Toledo Clinic Cancer Centers-Maumee
Maumee, Ohio, 43537
Status
Address
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
Maumee, Ohio, 43537
Status
Address
Licking Memorial Hospital
Newark, Ohio, 43055
Status
Address
Saint Charles Hospital
Oregon, Ohio, 43616
Status
Address
Toledo Clinic Cancer Centers-Oregon
Oregon, Ohio, 43616
Status
Address
North Coast Cancer Care
Sandusky, Ohio, 44870
Status
Address
Flower Hospital
Sylvania, Ohio, 43560
Status
Address
Mercy Hospital of Tiffin
Tiffin, Ohio, 44883
Status
Address
The Toledo Hospital/Toledo Children's Hospital
Toledo, Ohio, 43606
Status
Address
Saint Vincent Mercy Medical Center
Toledo, Ohio, 43608
Status
Address
University of Toledo
Toledo, Ohio, 43614
Status
Address
Toledo Community Hospital Oncology Program CCOP
Toledo, Ohio, 43617
Status
Address
Mercy Saint Anne Hospital
Toledo, Ohio, 43623
Status
Address
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, 43623
Status
Address
Upper Valley Medical Center
Troy, Ohio, 45373
Status
Address
Fulton County Health Center
Wauseon, Ohio, 43567
Status
Address
Saint Ann's Hospital
Westerville, Ohio, 43081
Status
Address
Clinton Memorial Hospital
Wilmington, Ohio, 45177
Status
Address
Greene Memorial Hospital
Xenia, Ohio, 45385
Status
Address
Genesis HealthCare System
Zanesville, Ohio, 43701
Status
Address
Geisinger Medical Center
Danville, Pennsylvania, 17822-2001
Status
Address
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, 18201
Status
Address
Geisinger Medical Group
State College, Pennsylvania, 16801
Status
Address
Geisinger Wyoming Valley
Wilkes-Barre, Pennsylvania, 18711
Status
Address
AnMed Health Hospital
Anderson, South Carolina, 29621
Status
Address
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303
Status
Address
Upstate Carolina CCOP
Spartanburg, South Carolina, 29303
Status
Address
Rapid City Regional Hospital
Rapid City, South Dakota, 57701
Status
Address
Fredericksburg Oncology Inc
Fredericksburg, Virginia, 22401
Status
Address
Midelfort Clinic-Clairemont Campus
Eau Claire, Wisconsin, 54702
Status
Address
Mayo Clinic Health System Eau Claire Hospital - Luther Campus
Eau Claire, Wisconsin, 54703
Status
Address
Agnesian Cancer Center
Fond Du Lac, Wisconsin, 54935
Status
Address
Rocky Mountain Oncology
Casper, Wyoming, 82609
Status
Address
Welch Cancer Center
Sheridan, Wyoming, 82801