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

Basic Trial Information

Trial Description

Summary

This randomized phase II trial studies how well giving azacitidine works with or without lenalidomide or vorinostat in treating patients with higher-risk myelodysplastic syndromes or chronic myelomonocytic leukemia. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or stopping them from dividing. Lenalidomide may stop the growth of cancer cells by stopping blood flow to the cancer. Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether azacitidine is more effective with or without lenalidomide or vorinostat in treating myelodysplastic syndromes or chronic myelomonocytic leukemia.

Further Study Information

PRIMARY OBJECTIVES:

I. To test whether the response rate (complete remission, partial remission, or hematologic improvement) of patients with higher-risk myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML) who receive either the combination of lenalidomide and azacitidine or the combination of vorinostat and azacitidine is improved compared to patients who receive single-agent azacitidine.

II. To estimate relapse-free survival, overall survival and cytogenetic response rate of patients treated on each regimen.

III. To estimate the frequency and severity of toxicities of the three regimens in this patient population.

IV. To investigate in a preliminary manner the frequency of subgroups from pre-study cytogenetic studies and correlate these subgroups with clinical outcomes in this patient population.

V. To collect specimens for banking for use in future research studies.

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

ARM I: Patients receive azacitidine subcutaneously (SC) or intravenously (IV) on days 1-7 or days 1-5 and 8-9, and lenalidomide orally (PO) once daily (QD) on days 1-21.

ARM II: Patients receive azacitidine as in arm I.

ARM III: Patients receive azacitidine as in arm I and vorinostat PO twice daily (BID) on days 3-9.

In all arms, courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for up to 5 years.

Eligibility Criteria

Inclusion Criteria:

• Patients must have morphologically confirmed diagnosis of myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML) based on one of the following:

• French-American-British (FAB) classifications:

• Refractory anemia with excess blasts (RAEB - defined as having 5-20% myeloblasts in the bone marrow)

• CMML with 10-19% myeloblasts in the bone marrow and/or 5-19% blasts in the blood

• World Health Organization (WHO) Classifications:

• RAEB-1 (defined as having 5-9% myeloblasts in the bone marrow)

• RAEB-2 (defined as having 10-19% myeloblasts in the bone marrow and/or 5-19% blasts in the blood)

• CMML-1 (defined as having < 5% myeloblasts in the bone marrow and/or < 10% blasts in the blood)

• CMML-2 (defined as having 10-19% myeloblasts in the bone marrow and/or 5-19% blasts in the blood)

• International prognostic score (IPSS) of Intermediate 2 (1.5-2.0 points) or High (>= 2.5 points); a score of Intermediate 1 (0.5-1.0 points) is only allowable in the setting of >= 5% myeloblasts

• Patients with acute myeloid leukemia (AML) are not eligible

• Procedures to obtain specimens for establishing baseline disease must be done within 30 days prior to registration

• Patients must not have received lenalidomide, azacitidine, vorinostat, or decitabine as treatment previously; any hematopoietic growth factors must be stopped for at least 14 days prior to registration

• Patients may have received low-dose cytarabine for MDS treatment previously, but they must have discontinued its use for at least 28 days prior to registration

• Patients must not have received radiation therapy, chemotherapy, or cytotoxic therapy to treat conditions other than MDS within 12 months prior to registration

• Patients must not have undergone prior allogeneic stem cell or bone marrow transplantation at any time; patients that have undergone an autologous stem cell transplant are eligible

• Patients must not have used or be using histone deacetylase (HDAC) inhibitor agents for anticancer treatment

• Patients may not have received agents such as valproic acid for epilepsy within 30 days prior to registration

• Patients must have Zubrod performance status of 0-2

• Patients must not have any pre-existing neurotoxicity/neuropathy of >= grade 2 according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Version 4.0, or prior >= grade 3 allergic reaction/hypersensitivity or rash to thalidomide that has not resolved to < grade 2

• Patients must not have any serious medical condition, laboratory abnormality, or psychiatric illness that, in the view of the treating physician, would place the participant at an unacceptable risk if he or she were to participate in the study or would prevent that person from giving informed consent

• Patients must not have history of thromboembolic event or other condition requiring current use of anticoagulation with Coumadin (warfarin) or low molecular-weight heparin

• Patients must not have known or suspected hypersensitivity to mannitol

• Patients must receive a 12-lead electrocardiogram (EKG), chest x-ray, serum creatinine, complete metabolic panel including serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT), electrolytes, and bilirubin testing within 28 days prior to registration in order to establish baseline measurements; questions regarding patient safety in regards to results of these tests should be directed to the Study Coordinator

• Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days prior to registration; FCBP must agree to have a second pregnancy test within 24 hours prior to starting course 1 if randomized to receive lenalidomide

• A FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)

• Patients must commit to the following if they are randomized to receive lenalidomide; FCBP must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before starting lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP, even if they have had a successful vasectomy

• All patients must be counseled by a trained counselor every 28 days about pregnancy precautions and risks of fetal exposure

• Patients not randomized to receive lenalidomide will not be required to undergo serial pregnancy testing or lenalidomide counseling after registration

• No prior malignancy is allowed except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for three years

• Cytogenetics requirements:

• Southwestern Oncology Group (SWOG) (and other sites not affiliated with Cancer and Leukemia Group B [CALGB] or Eastern Cooperative Oncology Group [ECOG]): Pretreatment cytogenetics must be performed on all patients; collection of pretreatment specimens must be completed within 14 days prior to registration to SWOG-S1117

• CALGB: CALGB patients must enroll on CALGB 8461, the cytogenetics protocol

• ECOG: Pretreatment cytogenetics must be performed on all patients; collection of pretreatment specimens must be completed within 30 days prior to registration to S1117

• Banking requirements:

• SWOG and ECOG (and other sites not affiliated with CALGB): Patients must be offered participation in specimen banking

• CALGB: CALGB patients must be offered participation in CALGB 9665, the CALGB Leukemia Tissue bank protocol

• National Cancer Institute of Canada (NCIC) Clinical Trials Group (CTG): NCIC CTG patients must be offered participation in specimen submission and banking

• All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines

• As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

Trial Contact Information

Trial Lead Organizations/Sponsors

National Cancer Institute

Mikkael Sekeres

Principal Investigator

U.S.A.
Alabama
	Birmingham
	UAB Comprehensive Cancer Center
		Harry Paul Erba	Ph: 205-934-0309
Arizona
	Scottsdale
	Mayo Clinic Scottsdale
		Mrinal M Patnaik	Ph: 507-538-7623
	Tucson
	Arizona Cancer Center at University Medical Center North
		Ravitharan Krishnadasan	Ph: 520-626-9008
	Arizona Cancer Center at University of Arizona Health Sciences Center
		Ravitharan Krishnadasan	Ph: 520-626-9008
California
	Antioch
	Kaiser Permanente - Deer Valley
		Tatjana Kolevska	Ph: 626-564-3455
	Duarte
	City of Hope Comprehensive Cancer Center
		Margaret R. O'Donnell	Ph: 800-826-4673
			Email: becomingapatient@coh.org
	Los Angeles
	USC/Norris Comprehensive Cancer Center and Hospital
		Casey L O'Connell	Ph: 323-865-0451
	Oakland
	Kaiser Permanente-Oakland
		Tatjana Kolevska	Ph: 626-564-3455
	Richmond
	Kaiser Permanente Medical Center - Richmond
		Tatjana Kolevska	Ph: 626-564-3455
	Sacramento
	Kaiser Permanente Medical Center - Sacramento
		Tatjana Kolevska	Ph: 626-564-3455
	South Sacramento Kaiser-Permanente Medical Center
		Tatjana Kolevska	Ph: 626-564-3455
	San Francisco
	Kaiser Permanente Medical Center - San Francisco Geary Campus
		Tatjana Kolevska	Ph: 626-564-3455
	San Jose
	Kaiser Permanente Medical Center - Santa Teresa
		Tatjana Kolevska	Ph: 626-564-3455
	San Rafael
	Kaiser Foundation Hospital - San Rafael
		Tatjana Kolevska	Ph: 626-564-3455
	Santa Clara
	Kaiser Permanente Medical Center - Santa Clara Homestead Campus
		Tatjana Kolevska	Ph: 626-564-3455
	Santa Rosa
	Sutter Pacific Medical Foundation
		David H. Irwin	Ph: 510-204-3428
	South San Francisco
	Kaiser Permanente Medical Center - South San Francisco
		Tatjana Kolevska	Ph: 626-564-3455
	Walnut Creek
	Kaiser Permanente Medical Center - Walnut Creek
		Tatjana Kolevska	Ph: 626-564-3455
Colorado
	Aurora
	Medical Center of Aurora - South Campus
		Eduardo R. Pajon	Ph: 888-785-6789
	Boulder
	Boulder Community Hospital
		Eduardo R. Pajon	Ph: 888-785-6789
	Colorado Springs
	Penrose Cancer Center at Penrose Hospital
		Eduardo R. Pajon	Ph: 888-785-6789
	Denver
	CCOP - Colorado Cancer Research Program
		Eduardo R. Pajon	Ph: 888-785-6789
	Porter Adventist Hospital
		Eduardo R. Pajon	Ph: 888-785-6789
	Presbyterian - St. Luke's Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
	Rose Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
	St. Anthony Central Hospital
		Eduardo R. Pajon	Ph: 888-785-6789
	St. Joseph Hospital
		Eduardo R. Pajon	Ph: 888-785-6789
	Englewood
	Swedish Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
	Fort Collins
	Front Range Cancer Specialists
		Diana C. Medgyesy	Ph: 970-212-7600
	Poudre Valley Hospital
		Paolo Romero	Ph: 970-495-8226
	Greeley
	North Colorado Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
	Lone Tree
	Sky Ridge Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
	Longmont
	Hope Cancer Care Center at Longmont United Hospital
		Eduardo R. Pajon	Ph: 888-785-6789
	Loveland
	McKee Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
	Parker
	Parker Adventist Hospital
		Eduardo R. Pajon	Ph: 888-785-6789
	Pueblo
	St. Mary - Corwin Regional Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
	Wheat Ridge
	Exempla Lutheran Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
Connecticut
	Hartford
	Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
		Christopher M Reynolds	Ph: 734-712-3456
	New Britain
	George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
		James S. Hoffman	Ph: 860-224-5660
Delaware
	Lewes
	Tunnell Cancer Center at Beebe Medical Center
		Stephen Scott Grubbs	Ph: 302-733-6227
	Newark
	Helen F. Graham Cancer Center at Christiana Hospital
		Stephen Scott Grubbs	Ph: 302-733-6227
Florida
	Jupiter
	Ella Milbank Foshay Cancer Center at Jupiter Medical Center
		Michael Schwartz	Ph: 305-674-2625
			Email: info@msccop.com
	Miami Beach
	CCOP - Mount Sinai Medical Center
		Michael Schwartz	Ph: 305-674-2625
			Email: info@msccop.com
	Orlando
	Florida Hospital Cancer Institute at Florida Hospital Orlando
		Lee M. Zehngebot	Ph: 407-303-5623
Georgia
	Augusta
	Medical College of Georgia Cancer Center
		Anand P. Jillella	Ph: 706-721-1663
			Email: cancer@georgiahealth.edu
Hawaii
	Honolulu
	Cancer Research Center of Hawaii
		Jeffrey L. Berenberg	Ph: 808-586-2979
	Kaiser Permanente - Moanalua Medical Center and Clinic
		Tatjana Kolevska	Ph: 626-564-3455
	OnCare Hawaii, Incorporated - Kuakini
		Jeffrey L. Berenberg	Ph: 808-586-2979
	OnCare Hawaii, Incorporated - Lusitana
		Jeffrey L. Berenberg	Ph: 808-586-2979
Illinois
	Bloomington
	Illinois CancerCare - Bloomington
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Canton
	Illinois CancerCare - Canton
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Carthage
	Illinois CancerCare - Carthage
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Chicago
	Robert H. Lurie Comprehensive Cancer Center at Northwestern University
		Olga Frankfurt	Ph: 312-695-1301
			Email: cancer@northwestern.edu
	University of Chicago Cancer Research Center
		Olatoyosi M. Odenike	Ph: 773-834-7424
	University of Illinois Cancer Center
		John G Quigley	Ph: 312-355-3046
	Decatur
	Decatur Memorial Hospital Cancer Care Institute
		James L. Wade	Ph: 217-876-4740
			Email: kcheek@dmhhs.org
	Eureka
	Illinois CancerCare - Eureka
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Evanston
	CCOP - Evanston
		Lynne S. Kaminer	Ph: 847-570-1381
	Galesburg
	Galesburg Clinic, PC
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Havana
	Illinois CancerCare - Havana
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Kewanee
	Illinois CancerCare - Kewanee Clinic
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Macomb
	Illinois CancerCare - Macomb
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Maywood
	Cardinal Bernardin Cancer Center at Loyola University Medical Center
		Danielle A Shafer	Ph: 708-226-4357
	Moline
	Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
		Costas L. Constantinou	Ph: 319-363-2690
	Monmouth
	Illinois CancerCare - Monmouth
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Normal
	Illinois CancerCare - Community Cancer Center
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Ottawa
	Illinois CancerCare - Ottawa
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Pekin
	Illinois CancerCare - Pekin
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Peoria
	CCOP - Illinois Oncology Research Association
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Illinois CancerCare - Peoria
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Peru
	Illinois CancerCare - Princeton
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Princeton
	Illinois CancerCare - Princeton
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Rockford
	Swedish-American Regional Cancer Center
		Harvey Eric Einhorn	Ph: 815-489-4413
	Springfield
	Regional Cancer Center at Memorial Medical Center
		James L. Wade	Ph: 217-876-4740
			Email: kcheek@dmhhs.org
Indiana
	Merrillville
	Premier Oncology Hematology Associates
		Bharat H. Barai	Ph: 219-736-2800
Iowa
	Ames
	McFarland Clinic, PC
		Joseph James Merchant	Ph: 515-239-2621
	Iowa City
	Holden Comprehensive Cancer Center at University of Iowa
		Thomas H Carter	Ph: 800-237-1225
	Sioux City
	Siouxland Hematology-Oncology Associates, LLP
		Donald Bruce Wender	Ph: 712-252-0088
	Waterloo
	Covenant Cancer Treatment Center
		Mohammed T. Masri	Ph: 319-272-2070
Kansas
	Topeka
	Cotton-O'Neil Cancer Center
		David E Einspahr	Ph: 785-270-4963
Kentucky
	Lexington
	University of Kentucky Chandler Medical Center
		Dianna S Howard	Ph: 859-257-3379
Louisiana
	Shreveport
	Feist-Weiller Cancer Center at Louisiana State University Health Sciences
		Nebu V Koshy	Ph: 318-813-1412
Maine
	Bangor
	CancerCare of Maine at Eastern Maine Medical Center
		Thomas Henry Openshaw	Ph: 207-973-4274
Maryland
	Baltimore
	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
		Steven D. Gore	Ph: 410-955-8804
			Email: jhcccro@jhmi.edu
	Elkton MD
	Union Hospital of Cecil County
		Stephen Scott Grubbs	Ph: 302-733-6227
Massachusetts
	Boston
	Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
		David P Steensma	Ph: 866-790-4500
	Massachusetts General Hospital
		David P Steensma	Ph: 866-790-4500
	Springfield
	Baystate Medical Center
		Syed S Ali	Ph: 413-794-3565
			Email: tamara.wrenn@baystatehealth.org
	Worcester
	UMASS Memorial Cancer Center - University Campus
		Muthalagu Ramanathan	Ph: 508-856-2464
			Email: laura.lefko@umassmed.edu
Michigan
	Ann Arbor
	Saint Joseph Mercy Cancer Center
		Christopher M Reynolds	Ph: 734-712-3456
	Detroit
	Wayne State University
		Jay Yang	Ph: 313-576-9363
	Escanaba
	Green Bay Oncology, Limited - Escanaba
		Matthew L Ryan	Ph: 800-432-6049
	Grand Rapids
	CCOP - Grand Rapids
		Gilbert D Padula	Ph: 616-685-5225
	Iron Mountain
	Green Bay Oncology - Iron Mountain
		Matthew L Ryan	Ph: 800-432-6049
	Kalamazoo
	West Michigan Cancer Center
		Raymond Sterling Lord	Ph: 269-373-7458
	Traverse City
	Munson Medical Center
		Gilbert D Padula	Ph: 616-685-5225
Minnesota
	Bemidji
	MeritCare Bemidji
		Preston D. Steen	Ph: 701-234-6161
	Burnsville
	Fairview Ridges Hospital
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Coon Rapids
	Mercy and Unity Cancer Center at Mercy Hospital
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Edina
	Fairview Southdale Hospital
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Fridley
	Mercy and Unity Cancer Center at Unity Hospital
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Hutchinson
	Hutchinson Area Health Care
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Maplewood
	HealthEast Cancer Care at St. John's Hospital
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Minnesota Oncology - Maplewood
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Minneapolis
	Hennepin County Medical Center - Minneapolis
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Robbinsdale
	Humphrey Cancer Center at North Memorial Outpatient Center
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Rochester
	Mayo Clinic Cancer Center
		Mrinal M Patnaik	Ph: 507-538-7623
	Saint Cloud
	CentraCare Clinic - Women and Children
		Donald J Jurgens	Ph: 877-229-4907
			Email: coborncancercenter@centracare.com
	Saint Louis Park
	CCOP - Metro-Minnesota
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Park Nicollet Cancer Center
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Saint Paul
	Regions Hospital Cancer Care Center
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	United Hospital
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Shakopee
	St. Francis Cancer Center at St. Francis Medical Center
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Stillwater
	Lakeview Hospital
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Waconia
	Ridgeview Medical Center
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Willmar
	Willmar Cancer Center at Rice Memorial Hospital
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
	Woodbury
	Minnesota Oncology - Woodbury
		Patrick J. Flynn	Ph: 952-993-1517
			Email: MMCCOP@parknicollet.com
Mississippi
	Jackson
	University of Mississippi Cancer Clinic
		Stephanie L Elkins	Ph: 601-815-6700
Missouri
	Columbia
	Ellis Fischel Cancer Center at University of Missouri - Columbia
		Carl E. Freter	Ph: 573-882-7440
	Kansas City
	Saint Luke's Hospital
		Rakesh Gaur	Ph: 913-948-5588
			Email: amy.krushelniski@hcahealthcare.com
	Saint Louis
	David C. Pratt Cancer Center at St. John's Mercy
		Bethany G. Sleckman	Ph: 913-948-5588
Montana
	Billings
	Billings Clinic Cancer Center - 801 N 29th Street
		Benjamin Thomas Marchello	Ph: 800-648-6274
	Bozeman
	Bozeman Deaconess Cancer Center
		Benjamin Thomas Marchello	Ph: 800-648-6274
New Jersey
	Camden
	Cancer Institute of New Jersey at Cooper University Hospital - Camden
		Stephen Scott Grubbs	Ph: 302-733-6227
New Mexico
	Albuquerque
	Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital
		Elizabeth A. McGuire	Ph: 505-727-8000
	University of New Mexico Cancer Center
		Elizabeth A. McGuire	Ph: 505-727-8000
New York
	Bronx
	Jack D. Weiler Hospital at Montefiore Medical Center - East Campus
		Amit Verma	Ph: 718-904-2730
			Email: aecc@aecom.yu.edu
	Montefiore Medical Center
		Amit Verma	Ph: 718-904-2730
			Email: aecc@aecom.yu.edu
	Buffalo
	Roswell Park Cancer Institute
		Eunice S Wang	Ph: 877-275-7724
	Lake Success
	Monter Cancer Center of the North Shore-LIJ Health System
		Cristina M Ghiuzeli	Ph: 516-562-3467
	Manhasset
	Don Monti Comprehensive Cancer Center at North Shore University Hospital
		Cristina M Ghiuzeli	Ph: 516-562-3467
	New York
	New York Weill Cornell Cancer Center at Cornell University
		Gail J Roboz	Ph: 212-746-1848
	Rochester
	James P. Wilmot Cancer Center at University of Rochester Medical Center
		Jonathan W Friedberg	Ph: 585-275-5830
North Carolina
	Asheboro
	Randolph Hospital
		Peter Rubin	Ph: 336-832-0821
	Goldsboro
	Wayne Memorial Hospital, Incorporated
		James N. Atkins	Ph: 919-580-0000
	Greensboro
	Moses Cone Regional Cancer Center at Wesley Long Community Hospital
		Peter Rubin	Ph: 336-832-0821
	Hendersonville
	Comprehensive Cancer Center at Pardee Hospital
		James E. Radford	Ph: 828-696-4716
	Kinston
	Kinston Medical Specialists
		Peter R. Watson	Ph: 252-559-2200
	Pinehurst
	FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
		Charles S Kuzma	Ph: 910-715-2200
	Reidsville
	Annie Penn Cancer Center
		Peter Rubin	Ph: 336-832-0821
	Statesville
	Iredell Memorial Hospital
		Ruby A. Grimm	Ph: 704-873-5661
North Dakota
	Bismarck
	Medcenter One Hospital Cancer Care Center
		Edward J. Wos	Ph: 701-323-5760
			Email: tfischer@mohs.org
	Mid Dakota Clinic, PC
		Edward J. Wos	Ph: 701-323-5760
			Email: tfischer@mohs.org
	Fargo
	Roger Maris Cancer Center at MeritCare Hospital
		Preston D. Steen	Ph: 701-234-6161
		Preston D. Steen	Ph: 701-234-6161
	Sanford Clinic North-Fargo
		Preston D. Steen	Ph: 701-234-6161
Ohio
	Beachwood
	Cleveland Clinic Taussig Cancer Center
		Anjali S Advani	Ph: 866-223-8100
	Cleveland
	Cleveland Clinic Cancer Center at Fairview Hospital
		Anjali S Advani	Ph: 866-223-8100
	Cleveland Clinic Taussig Cancer Center
		Anjali S Advani	Ph: 866-223-8100
	Dayton
	David L. Rike Cancer Center at Miami Valley Hospital
		Howard M. Gross	Ph: 765-983-3000
	Independence
	Cleveland Clinic Taussig Cancer Center
		Anjali S Advani	Ph: 866-223-8100
	Mayfield Heights
	Hillcrest Cancer Center at Hillcrest Hospital
		Anjali S Advani	Ph: 866-223-8100
	Parma
	Parma Community General Hospital
		Anjali S Advani	Ph: 866-223-8100
	Sandusky
	North Coast Cancer Care, Incorporated
		Anjali S Advani	Ph: 866-223-8100
	Strongsville
	Cleveland Clinic Foundation - Strongsville
		Anjali S Advani	Ph: 866-223-8100
	Toledo
	University of Toledo Medical Center
		Rex B Mowat	Ph: 517-265-0116
	Wooster
	Cleveland Clinic - Wooster
		Anjali S Advani	Ph: 866-223-8100
Oklahoma
	Norman
	Cancer Care Associates - Norman
		Vikki Ann Canfield	Ph: 888-823-5923
			Email: ctsucontact@westat.com
	Oklahoma City
	Cancer Care Associates - Mercy Campus
		Vikki Ann Canfield	Ph: 888-823-5923
			Email: ctsucontact@westat.com
	Oklahoma University Cancer Institute
		George B Selby	Ph: 405-271-4272
			Email: julie-traylor@ouhsc.edu
Oregon
	Milwaukie
	Providence Milwaukie Hospital
		Alison K Conlin	Ph: 503-215-6412
	Newberg
	Providence Newberg Medical Center
		Alison K Conlin	Ph: 503-215-6412
	Oregon City
	Willamette Falls Hospital
		Alison K Conlin	Ph: 503-215-6412
	Portland
	Legacy Good Samaritan Hospital & Comprehensive Cancer Center
		Jacqueline Vuky	Ph: 503-299-6500
	Providence Cancer Center at Providence Portland Medical Center
		Alison K Conlin	Ph: 503-215-6412
	Providence St. Vincent Medical Center
		Alison K Conlin	Ph: 503-215-6412
Pennsylvania
	Allentown
	Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
		Eliot Lawrence Friedman	Ph: 610-402-2273
	Doylestown
	Doylestown Hospital Cancer Center
		Mitchell Alden	Ph: 215-345-2378
			Email: lheacock@dh.org
	Pittsburgh
	UPMC Cancer Centers
		Robert Redner	Ph: 412-647-8073
	West Reading
	McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
		Terrence P. Cescon	Ph: 610-988-9323
South Carolina
	Greenville
	Bon Secours St. Francis Health System
		James Dewitt Bearden	Ph: 800-486-5941
	Cancer Centers of the Carolinas - Faris Road
		Jeffrey Kent Giguere	Ph: 864-241-6251
	Cancer Centers of the Carolinas - Grove Commons
		Jeffrey Kent Giguere	Ph: 864-241-6251
	CCOP - Greenville
		Jeffrey Kent Giguere	Ph: 864-241-6251
	Greenville Memorial Hospital
		Jeffrey Kent Giguere	Ph: 864-241-6251
	Greer
	Cancer Centers of the Carolinas - Greer Medical Oncology
		Jeffrey Kent Giguere	Ph: 864-241-6251
	Seneca
	Cancer Centers of the Carolinas - Seneca
		Jeffrey Kent Giguere	Ph: 864-241-6251
	Spartanburg
	Cancer Centers of the Carolinas - Spartanburg
		Jeffrey Kent Giguere	Ph: 864-241-6251
	CCOP - Upstate Carolina
		James Dewitt Bearden	Ph: 800-486-5941
	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
		James Dewitt Bearden	Ph: 800-486-5941
South Dakota
	Rapid City
	Rapid City Regional Hospital
		Mark T Schroeder	Ph: 605-716-3982
			Email: research@rcrh.org
	Sioux Falls
	Sanford Cancer Center at Sanford USD Medical Center
		Miroslaw A Mazurczak	Ph: 605-328-1367
		Miroslaw A Mazurczak	Ph: 605-328-1367
Tennessee
	Knoxville
	Thompson Cancer Survival Center
		Samuel Spence McCachren	Ph: 865-541-1812
Texas
	Amarillo
	Harrington Cancer Center
		Stewart Allen Sharp	Ph: 806-359-4673
			Email: ryokubaitis@harringtoncc.org
Utah
	Salt Lake City
	Huntsman Cancer Institute at University of Utah
		Paul J. Shami	Ph: 801-581-4477
			Email: clinical.trials@hci.utah.edu
Washington
	Vancouver
	Southwest Washington Medical Center Cancer Center
		Alison K Conlin	Ph: 503-215-6412
Wisconsin
	Eau Claire
	Center for Cancer Treatment & Prevention at Sacred Heart Hospital
		Ali W. Bseiso	Ph: 715-389-4457
	Marshfield Clinic Cancer Care at Regional Cancer Center
		Ali W. Bseiso	Ph: 715-389-4457
	Green Bay
	Green Bay Oncology, Limited at St. Mary's Hospital
		Matthew L Ryan	Ph: 800-432-6049
	Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
		Matthew L Ryan	Ph: 800-432-6049
	St. Mary's Hospital Medical Center - Green Bay
		Matthew L Ryan	Ph: 800-432-6049
	St. Vincent Hospital Regional Cancer Center
		Matthew L Ryan	Ph: 800-432-6049
	Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
		Dhimant R. Patel	Ph: 800-252-2990
	Janesville
	Mercy Regional Cancer Center
		Robert Delaune	Ph: 800-928-1103
	La Crosse
	Gundersen Lutheran Center for Cancer and Blood
		Kurt Oettel	Ph: 608-775-2385
			Email: cancerctr@gundluth.org
	Madison
	Dean Hematology & Oncology Clinic
		Amit Sanyal	Ph: 608-410-2700
	Marinette
	Vince Lombardi Cancer Clinic - Marinette
		Dhimant R. Patel	Ph: 800-252-2990
	Marshfield
	Marshfield Clinic - Marshfield Center
		Ali W. Bseiso	Ph: 715-389-4457
	Saint Joseph's Hospital
		Ali W. Bseiso	Ph: 715-389-4457
	Milwaukee
	Froedtert Hospital and Medical College of Wisconsin
		Ehab L Atallah	Ph: 414-805-4380
	Minocqua
	Marshfield Clinic - Lakeland Center
		Ali W. Bseiso	Ph: 715-389-4457
	Oconomowoc
	Regional Cancer Center at Oconomowoc Memorial Hospital
		Michael A Thompson	Ph: 262-928-7632
	Oconto Falls
	Green Bay Oncology, Limited - Oconto Falls
		Matthew L Ryan	Ph: 800-432-6049
	Rhinelander
	Ministry Medical Group at Saint Mary's Hospital
		Ali W. Bseiso	Ph: 715-389-4457
	Rice Lake
	Marshfield Clinic - Indianhead Center
		Ali W. Bseiso	Ph: 715-389-4457
	Stevens Point
	Marshfield Clinic at Saint Michael's Hospital
		Ali W. Bseiso	Ph: 715-389-4457
	Saint Michael's Hospital Cancer Center
		Ali W. Bseiso	Ph: 715-389-4457
	Sturgeon Bay
	Green Bay Oncology, Limited - Sturgeon Bay
		Matthew L Ryan	Ph: 800-432-6049
	Summit
	Aurora Medical Center
		Dhimant R. Patel	Ph: 800-252-2990
	Waukesha
	Waukesha Memorial Hospital Regional Cancer Center
		Michael A Thompson	Ph: 262-928-7632
	Wauwatosa
	Oncology Alliance, SC - Milwaukee - West
		Rubina Qamar	Ph: 888-709-2080
	Weston
	Marshfield Clinic - Weston Center
		Ali W. Bseiso	Ph: 715-389-4457
	Wisconsin Rapids
	Marshfield Clinic - Wisconsin Rapids Center
		Ali W. Bseiso	Ph: 715-389-4457
Canada
Alberta
	Calgary
	Tom Baker Cancer Centre - Calgary
		Mary L Savoie	Ph: 403-521-3433
Ontario
	Toronto
	Odette Cancer Centre at Sunnybrook
		Rena J Buckstein	Ph: 416-480-5000

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01522976
Information obtained from ClinicalTrials.gov on April 22, 2013

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