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Azacitidine With or Without Lenalidomide or Vorinostat in Patients With Higher-Risk Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITissue collection/Repository, TreatmentActive18 and overNCINCI-2012-00242
SWOG-S1117, CDR0000723909, S1117, U10CA032102, NCT01522976

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.

SECONDARY OBJECTIVES:

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

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

III. 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.

IV. 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 SekeresPrincipal Investigator

Trial Sites

U.S.A.
Alabama
  Birmingham
 UAB Comprehensive Cancer Center
 Harry Paul Erba Ph: 205-934-0309
  Mobile
 University of South Alabama Mitchell Cancer Institute
 David R Clarkson Ph: 251-665-8000
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
Arkansas
  Little Rock
 Veterans Affairs Medical Center - Little Rock
 Rangaswamy Govindarajan Ph: 501-686-8274
California
  Antioch
 Kaiser Permanente - Deer Valley
 Tatjana Kolevska Ph: 626-564-3455
  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
 Kaiser Permanente Medical Center - Santa Rosa
 Tatjana Kolevska Ph: 626-564-3455
  South San Francisco
 Kaiser Permanente Medical Center - South San Francisco
 Tatjana Kolevska Ph: 626-564-3455
  Stanford
 Stanford Cancer Center
 Bruno C de Medeiros Ph: 650-498-7061
  Email: ccto-office@stanford.edu
  Walnut Creek
 Kaiser Permanente Medical Center - Walnut Creek
 Tatjana Kolevska Ph: 626-564-3455
Colorado
  Aurora
 Medical Center of Aurora - South Campus
 Keren Sturtz Ph: 888-785-6789
 University of Colorado Cancer Center at UC Health Sciences Center
 Daniel A Pollyea Ph: 720-848-0650
  Boulder
 Boulder Community Hospital
 Keren Sturtz Ph: 888-785-6789
  Colorado Springs
 Penrose Cancer Center at Penrose Hospital
 Keren Sturtz Ph: 888-785-6789
  Denver
 CCOP - Colorado Cancer Research Program
 Keren Sturtz Ph: 888-785-6789
 Colorado Blood Cancer Institute
 Keren Sturtz Ph: 888-785-6789
 Porter Adventist Hospital
 Keren Sturtz Ph: 888-785-6789
 Presbyterian - St. Luke's Medical Center
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers - Denver Midtown
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers-Rose
 Keren Sturtz Ph: 888-785-6789
 Rose Medical Center
 Keren Sturtz Ph: 888-785-6789
 St. Joseph Hospital
 Keren Sturtz Ph: 888-785-6789
  Durango
 Mercy Medical Center
 Cynthia K. Cathcart Ph: 888-785-6789
  Englewood
 Comprehensive Cancer Care and Research Institute of Colorado LLC
 Keren Sturtz Ph: 888-785-6789
 Swedish Medical Center
 Keren Sturtz Ph: 888-785-6789
  Fort Collins
 Poudre Valley Hospital
 Regina J Brown Ph: 970-297-6150
  Golden
 Mountain Blue Cancer Care Center
 Keren Sturtz Ph: 888-785-6789
  Greeley
 North Colorado Medical Center
 Keren Sturtz Ph: 888-785-6789
  Greenwood Village
 Breast Cancer Care Consultants
 Keren Sturtz Ph: 888-785-6789
  Lakewood
 Rocky Mountain Cancer Centers-Lakewood
 Keren Sturtz Ph: 888-785-6789
 St. Anthony Central Hospital
 Keren Sturtz Ph: 888-785-6789
  Littleton
 Littleton Adventist Hospital
 Keren Sturtz Ph: 888-785-6789
  Lone Tree
 Rocky Mountain Cancer Centers - Lone Tree
 Keren Sturtz Ph: 888-785-6789
 Sky Ridge Medical Center
 Keren Sturtz Ph: 888-785-6789
  Longmont
 Hope Cancer Care Center at Longmont United Hospital
 Keren Sturtz Ph: 888-785-6789
  Loveland
 McKee Medical Center
 Keren Sturtz Ph: 888-785-6789
  Parker
 Parker Adventist Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers - Parker
 Keren Sturtz Ph: 888-785-6789
  Pueblo
 St. Mary - Corwin Regional Medical Center
 Keren Sturtz Ph: 888-785-6789
  Wheat Ridge
 Exempla Lutheran Medical Center
 Keren Sturtz Ph: 888-785-6789
Connecticut
  Farmington
 Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
 Jeffrey S. Wasser Ph: 800-579-7822
  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
 Brian J Byrne 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
District of Columbia
  Washington
 Sibley Memorial Hospital
 Bruce R. Kressel Ph: 202-243-2373
 Veterans Affairs Medical Center - Washington, DC
 Dalia A Mobarek Ph: 877-328-2621
Florida
  Gainesville
 UF Health Cancer Center
 Jack W Hsu Ph: 352-273-8675
  Email: trials@cancer.ufl.edu
  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
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
 Straub Clinic and Hospital, Incorporated
 Jeffrey L. Berenberg Ph: 808-586-2979
Idaho
  Boise
 Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
 Christopher M Reynolds Ph: 734-712-3456
  Post Falls
 Kootenai Cancer Center - Post Falls
 Benjamin Thomas Marchello Ph: 800-648-6274
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: 847-570-2109
  Galesburg
 Galesburg Clinic, PC
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 Medical and Surgical Specialists, LLC
 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
 David M Spector Ph: 309-779-4200
  Monmouth
 Illinois CancerCare - Monmouth
 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
 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
  Urbana
 Carle Cancer Center at Carle Foundation Hospital
 Vamsi K Vasireddy Ph: 800-446-5532
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
  Kansas City
 Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
 Peter J. VanVeldhuizen Ph: 800-525-1483
  Prairie Village
 CCOP - Kansas City
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
  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
  Baton Rouge
 Ochsner Health Center - Bluebonnet
 Robert V. Emmons Ph: 888-562-4763
  New Orleans
 Ochsner Cancer Institute at Ochsner Clinic Foundation
 Robert V. Emmons Ph: 888-562-4763
  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
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
  Brighton
 Caritas St. Elizabeth's Medical Center
 Uma Narayanasami Ph: 617-789-2903
  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: 508-856-3216
  Email: cancer.research@umassmed.edu
Michigan
  Ann Arbor
 Saint Joseph Mercy Cancer Center
 Christopher M Reynolds Ph: 734-712-3456
  Battle Creek
 Battle Creek Health System Cancer Care Center
 Gilbert D Padula Ph: 616-685-5225
  Detroit
 Van Elslander Cancer Center at St. John Hospital and Medical Center
 Christopher M Reynolds Ph: 734-712-3456
 Wayne State University
 Jay Yang Ph: 313-576-9363
  Escanaba
 Green Bay Oncology, Limited - Escanaba
 Matthew L Ryan Ph: 800-432-6049
  Grand Rapids
 Butterworth Hospital at Spectrum Health
 Gilbert D Padula Ph: 616-685-5225
 CCOP - Grand Rapids
 Gilbert D Padula Ph: 616-685-5225
 Lacks Cancer Center at Saint Mary's Health Care
 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
  Muskegon
 Mercy General Health Partners
 Gilbert D Padula Ph: 616-685-5225
  Port Huron
 Mercy Regional Cancer Center at Mercy Hospital
 Christopher M Reynolds Ph: 734-712-3456
  Reed City
 Spectrum Health Reed City Hospital
 Gilbert D Padula Ph: 616-685-5225
  Traverse City
 Munson Medical Center
 Gilbert D Padula Ph: 616-685-5225
  Warren
 St. John Macomb Hospital
 Christopher M Reynolds Ph: 734-712-3456
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
  Duluth
 CCOP - Duluth
 Daniel Nikcevich Ph: 888-203-7267
  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
 Veterans Affairs Medical Center - Minneapolis
 Sharon D Luikart Ph: 612-467-2800
 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
  Cape Girardeau
 Saint Francis Medical Center
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Columbia
 Ellis Fischel Cancer Center at University of Missouri - Columbia
 Carl E. Freter Ph: 573-882-7440
 Veterans Affairs Medical Center - Columbia (Truman Memorial)
 Shadi M Haddadin Ph: 888-823-5923
  Email: ctsucontact@westat.com
  Kansas City
 Saint Luke's Hospital
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
  Saint Louis
 David C. Pratt Cancer Center at St. John's Mercy
 Jay W Carlson Ph: 888-244-6061
  Email: sherrijr@iora.org
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: 505-272-6972
 University of New Mexico Cancer Center
 Elizabeth A. McGuire Ph: 505-272-6972
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
  Manhasset
 Don Monti Comprehensive Cancer Center at North Shore University Hospital
 Cristina M Ghiuzeli Ph: 516-562-3467
  Mineola
 Winthrop University Hospital
 Harry Staszewski Ph: 866-946-8476
  New Hyde Park
 Monter Cancer Center of the North Shore-LIJ Health System
 Cristina M Ghiuzeli Ph: 516-562-3467
  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
 Preston D. Steen Ph: 701-234-6161
  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
  Cincinnati
 University of Cincinnati
 John Charles Morris Ph: 513-558-4553
  Email: uchealthnews@uc.edu
  Cleveland
 Case Comprehensive Cancer Center
 Brenda W. Cooper Ph: 800-641-2422
 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
  Columbus
 CCOP - Columbus
 J. Philip Kuebler Ph: 800-446-5532
 Mount Carmel Health - West Hospital
 J. Philip Kuebler Ph: 800-446-5532
 Riverside Methodist Hospital Cancer Care
 J. Philip Kuebler Ph: 800-446-5532
 Zangmeister Center
 J. Philip Kuebler Ph: 800-446-5532
  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
  Marietta
 Strecker Cancer Center at Marietta Memorial Hospital
 J. Philip Kuebler Ph: 800-446-5532
  Mayfield Heights
 Hillcrest Cancer Center at Hillcrest Hospital
 Anjali S Advani Ph: 866-223-8100
  Newark
 Licking Memorial Cancer Care Program at Licking Memorial Hospital
 J. Philip Kuebler Ph: 800-446-5532
  Sandusky
 North Coast Cancer Care, Incorporated
 Anjali S Advani Ph: 866-223-8100
  Springfield
 Community Hospital of Springfield and Clark County
 J. Philip Kuebler Ph: 800-446-5532
  Strongsville
 Cleveland Clinic Foundation - Strongsville
 Anjali S Advani Ph: 866-223-8100
  Sylvania
 Flower Hospital Cancer Center
 Rex B Mowat Ph: 517-265-0116
  Toledo
 University of Toledo Medical Center
 Rex B Mowat Ph: 517-265-0116
  Westerville
 Mount Carmel St. Ann's Cancer Center
 J. Philip Kuebler Ph: 800-446-5532
  Wooster
 Cleveland Clinic - Wooster
 Anjali S Advani Ph: 866-223-8100
Oklahoma
  Norman
 Cancer Care Associates - Norman
 Vikki Ann Canfield Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
  Oklahoma City
 Cancer Care Associates - Mercy Campus
 Vikki Ann Canfield Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
 Oklahoma University Cancer Institute
 George B Selby Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
Oregon
  Gresham
 Legacy Mount Hood Medical Center
 Jacqueline Vuky Ph: 503-299-6500
  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
  Carlisle
 Carlisle Cancer Center
 David F Claxton Ph: 717-531-3779
  Email: CTO@hmc.psu.edu
  Danville
 Geisinger Cancer Institute at Geisinger Health
 Edward J Gorak Ph: 570-271-5251
  Doylestown
 Doylestown Hospital Cancer Center
 Mitchell Alden Ph: 215-345-2378
  Email: lheacock@dh.org
  Hazleton
 Geisinger Hazleton Cancer Center
 Edward J Gorak Ph: 570-271-5251
  Hershey
 Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
 David F Claxton Ph: 717-531-3779
  Email: CTO@hmc.psu.edu
  Pittsburgh
 UPMC Cancer Centers
 Annie P Im Ph: 412-647-8073
  Sayre
 Guthrie Cancer Center at Guthrie Clinic Sayre
 Edward T. O'Brien Ph: 800-836-0388
  West Reading
 McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
 Terrence P. Cescon Ph: 610-988-9323
  Wilkes-Barre
 Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
 Edward J Gorak Ph: 570-271-5251
South Carolina
  Charleston
 Roper St. Francis Cancer Center at Roper Hospital
 James Michael Orcutt Ph: 843-720-8386
  Email: elizabeth.strojny@roperstfrancis.com
  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
  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
  Nashville
 Vanderbilt-Ingram Cancer Center
 Sanjay R Mohan Ph: 800-811-8480
Texas
  Amarillo
 Harrington Cancer Center
 Stewart Allen Sharp Ph: 806-359-4673
  Email: ryokubaitis@harringtoncc.org
  Dallas
 Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
 Prapti Patel Ph: 214-648-7097
Utah
  Salt Lake City
 Huntsman Cancer Institute at University of Utah
 Paul J. Shami Ph: 801-581-4477
  Email: clinical.trials@hci.utah.edu
Virginia
  Martinsville
 Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
 Sreedhar Katragadda Ph: 276-666-7827
Washington
  Vancouver
 Southwest Washington Medical Center Cancer Center
 Alison K Conlin Ph: 503-215-6412
West Virginia
  Morgantown
 Mary Babb Randolph Cancer Center at West Virginia University Hospitals
 Soumit K Basu Ph: 304-293-2745
  Email: sfilburn@hsc.wvu.edu
Wisconsin
  Chippewa Falls
 Marshfield Clinic - Chippewa Center
 Ali W. Bseiso Ph: 715-389-4457
  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
 Bay Area Cancer Care Center at Bay Area Medical Center
 Matthew L Ryan Ph: 800-432-6049
 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
 Timothy R Wassenaar Ph: 262-928-7878
  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
 Timothy R Wassenaar Ph: 262-928-7878
  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
British Columbia
  Vancouver
 Vancouver Coastal Health
 Sujaatha Narayanan
  Email: research@vch.ca
Manitoba
  Winnipeg
 CancerCare Manitoba
 Rajat Kumar Ph: 866-561-1026
  Email: CIO_Web@cancercare.mb.ca
New Brunswick
  Moncton
 Moncton Hospital
 Sheldon H. Rubin Ph: 506-857-5267
  Saint John
 Saint John Regional Hospital
 Terrance Comeau Ph: 506-648-6890
Nova Scotia
  Halifax
 Nova Scotia Cancer Centre
 Andrea K Kew Ph: 902-473-6000
Ontario
  Hamilton
 Margaret and Charles Juravinski Cancer Centre
 Brian F Leber Ph: 905-387-9495
  Toronto
 Odette Cancer Centre at Sunnybrook
 Rena J Buckstein Ph: 416-480-5000
 Princess Margaret Hospital
 Karen W. L. Yee Ph: 416-946-4501
  Email: clinical.trials@uhn.on.ca
Quebec
  Greenfield Park
 Hopital Charles Lemoyne
 Celine Devaux Ph: 450-466-5065
  Montreal
 McGill Cancer Centre at McGill University
 John M Storring Ph: 514-398-1444
  Email: penny.chipman@mcgill.ca
Saskatchewan
  Regina
 Allan Blair Cancer Centre at Pasqua Hospital
 Vamsee K Torri Ph: 306-766-2213
  Saskatoon
 Saskatoon Cancer Centre at the University of Saskatchewan
 Waleed S Ismail Ph: 306-655-2914

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01522976
ClinicalTrials.gov processed this data on March 19, 2014

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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