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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
S1117, SWOG-S1117, CDR0000723909, 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.

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 SekeresPrincipal Investigator

Trial Sites

U.S.A.
Arizona
  Scottsdale
 Mayo Clinic Scottsdale
 Mrinal M. Patnaik Ph: 507-538-7623
 Mrinal M. PatnaikPrincipal Investigator
  Tucson
 Arizona Cancer Center at University of Arizona Health Sciences Center
 Ravitharan Krishnadasan Ph: 520-626-9008
 Ravitharan KrishnadasanPrincipal Investigator
 Ravitharan Krishnadasan Ph: 520-626-9008
 Ravitharan KrishnadasanPrincipal Investigator
California
  Antioch
 Kaiser Permanente-Deer Valley Medical Center
 Tatjana Kolevska Ph: 626-564-3455
 Tatjana KolevskaPrincipal Investigator
  Duarte
 City of Hope Comprehensive Cancer Center
 Margaret R. O'Donnell Ph: 800-826-4673
  Email: becomingapatient@coh.org
 Margaret R. O'DonnellPrincipal Investigator
  Los Angeles
 USC/Norris Comprehensive Cancer Center and Hospital
 Casey L. O'Connell Ph: 323-865-0451
 Casey L. O'ConnellPrincipal Investigator
  Oakland
 Kaiser Permanente Medical Center - Oakland
 Tatjana Kolevska Ph: 626-564-3455
 Tatjana KolevskaPrincipal Investigator
  Richmond
 Kaiser Permanente Medical Center - Richmond
 Tatjana Kolevska Ph: 626-564-3455
 Tatjana KolevskaPrincipal Investigator
  Sacramento
 Kaiser Permanente Medical Center - Sacramento
 Tatjana Kolevska Ph: 626-564-3455
 Tatjana KolevskaPrincipal Investigator
 South Sacramento Kaiser-Permanente Medical Center
 Tatjana Kolevska Ph: 626-564-3455
 Tatjana KolevskaPrincipal Investigator
  San Francisco
 Kaiser Permanente Medical Center - San Francisco Geary Campus
 Tatjana Kolevska Ph: 626-564-3455
 Tatjana KolevskaPrincipal Investigator
  San Jose
 Kaiser Permanente Medical Center - Santa Teresa
 Tatjana Kolevska Ph: 626-564-3455
 Tatjana KolevskaPrincipal Investigator
  San Rafael
 Kaiser Foundation Hospital - San Rafael
 Tatjana Kolevska Ph: 626-564-3455
 Tatjana KolevskaPrincipal Investigator
  Santa Clara
 Kaiser Permanente Medical Center - Santa Clara Kiely Campus
 Tatjana Kolevska Ph: 626-564-3455
 Tatjana KolevskaPrincipal Investigator
  South San Francisco
 Kaiser Permanente Medical Center - South San Francisco
 Tatjana Kolevska Ph: 626-564-3455
 Tatjana KolevskaPrincipal Investigator
  Walnut Creek
 Kaiser Permanente Medical Center - Walnut Creek
 Tatjana Kolevska Ph: 626-564-3455
 Tatjana KolevskaPrincipal Investigator
Colorado
  Aurora
 Medical Center of Aurora - South Campus
 Eduardo R. Pajon Ph: 888-785-6789
 Eduardo R. PajonPrincipal Investigator
  Boulder
 Boulder Community Hospital
 Eduardo R. Pajon Ph: 888-785-6789
 Eduardo R. PajonPrincipal Investigator
  Colorado Springs
 Penrose Cancer Center at Penrose Hospital
 Eduardo R. Pajon Ph: 888-785-6789
 Eduardo R. PajonPrincipal Investigator
  Denver
 CCOP - Colorado Cancer Research Program
 Eduardo R. Pajon Ph: 888-785-6789
 Eduardo R. PajonPrincipal Investigator
 Porter Adventist Hospital
 Eduardo R. Pajon Ph: 888-785-6789
 Eduardo R. PajonPrincipal Investigator
 Presbyterian - St. Luke's Medical Center
 Eduardo R. Pajon Ph: 888-785-6789
 Eduardo R. PajonPrincipal Investigator
 Rose Medical Center
 Eduardo R. Pajon Ph: 888-785-6789
 Eduardo R. PajonPrincipal Investigator
 St. Anthony Central Hospital
 Eduardo R. Pajon Ph: 888-785-6789
 Eduardo R. PajonPrincipal Investigator
 St. Joseph Hospital
 Eduardo R. Pajon Ph: 888-785-6789
 Eduardo R. PajonPrincipal Investigator
  Englewood
 Swedish Medical Center
 Eduardo R. Pajon Ph: 888-785-6789
 Eduardo R. PajonPrincipal Investigator
  Fort Collins
 Front Range Cancer Specialists
 Diana C. Medgyesy Ph: 970-212-7600
 Diana C. MedgyesyPrincipal Investigator
 Poudre Valley Hospital
 Paolo Romero Ph: 970-495-8226
 Paolo RomeroPrincipal Investigator
  Greeley
 North Colorado Medical Center
 Eduardo R. Pajon Ph: 888-785-6789
 Eduardo R. PajonPrincipal Investigator
  Lone Tree
 Sky Ridge Medical Center
 Eduardo R. Pajon Ph: 888-785-6789
 Eduardo R. PajonPrincipal Investigator
  Longmont
 Hope Cancer Care Center at Longmont United Hospital
 Eduardo R. Pajon Ph: 888-785-6789
 Eduardo R. PajonPrincipal Investigator
  Loveland
 McKee Medical Center
 Eduardo R. Pajon Ph: 888-785-6789
 Eduardo R. PajonPrincipal Investigator
  Parker
 Parker Adventist Hospital
 Eduardo R. Pajon Ph: 888-785-6789
 Eduardo R. PajonPrincipal Investigator
  Pueblo
 St. Mary - Corwin Regional Medical Center
 Eduardo R. Pajon Ph: 888-785-6789
 Eduardo R. PajonPrincipal Investigator
  Wheat Ridge
 Exempla Lutheran Medical Center
 Eduardo R. Pajon Ph: 888-785-6789
 Eduardo R. PajonPrincipal Investigator
Connecticut
  Hartford
 Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
 Christopher M. Reynolds Ph: 734-712-3456
 Christopher M. ReynoldsPrincipal Investigator
  New Britain
 George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
 James S. Hoffman Ph: 860-224-5660
 James S. HoffmanPrincipal Investigator
Delaware
  Lewes
 Tunnell Cancer Center at Beebe Medical Center
 Stephen S. Grubbs Ph: 302-733-6227
 Stephen S. GrubbsPrincipal Investigator
  Newark
 Helen F. Graham Cancer Center at Christiana Hospital
 Stephen S. Grubbs Ph: 302-733-6227
 Stephen S. GrubbsPrincipal Investigator
Florida
  Jupiter
 Ella Milbank Foshay Cancer Center at Jupiter Medical Center
 Michael A. Schwartz Ph: 305-674-2625
  Email: info@msccop.com
 Michael A. SchwartzPrincipal Investigator
  Miami Beach
 CCOP - Mount Sinai Medical Center
 Michael A. Schwartz Ph: 305-674-2625
  Email: info@msccop.com
 Michael SchwartzPrincipal Investigator
  Orlando
 Florida Hospital Cancer Institute at Florida Hospital Orlando
 Lee M. Zehngebot Ph: 407-303-5623
 Lee M. ZehngebotPrincipal Investigator
Georgia
  Augusta
 Medical College of Georgia Cancer Center
 Anand P. Jillella Ph: 706-721-1663
  Email: cancer@georgiahealth.edu
 Anand P. JillellaPrincipal Investigator
Hawaii
  Honolulu
 Cancer Research Center of Hawaii
 Jeffrey L. Berenberg Ph: 808-586-2979
 Jeffrey L. BerenbergPrincipal Investigator
 Kaiser Permanente - Moanalua Medical Center and Clinic
 Tatjana Kolevska Ph: 626-564-3455
 Tatjana KolevskaPrincipal Investigator
 OnCare Hawaii, Incorporated - Kuakini
 Jeffrey L. Berenberg Ph: 808-586-2979
 Jeffrey L. BerenbergPrincipal Investigator
 OnCare Hawaii, Incorporated - Lusitana
 Jeffrey L. Berenberg Ph: 808-586-2979
 Jeffrey L. BerenbergPrincipal Investigator
Illinois
  Bloomington%
 Illinois CancerCare - Bloomington
 Nguyet A. Le-Lindqwister Ph: 800-793-2262
 Nguyet A. Le-LindqwisterPrincipal Investigator
  Canton
 Illinois CancerCare - Canton
 Nguyet A. Le-Lindqwister Ph: 800-793-2262
 Nguyet A. Le-LindqwisterPrincipal Investigator
  Carthage
 Illinois CancerCare - Carthage
 Nguyet A. Le-Lindqwister Ph: 800-793-2262
 Nguyet A. Le-LindqwisterPrincipal Investigator
  Chicago
 Robert H. Lurie Comprehensive Cancer Center at Northwestern University
 Olga Frankfurt Ph: 312-695-1301
  Email: cancer@northwestern.edu
 Olga FrankfurtPrincipal Investigator
 University of Chicago Cancer Research Center
 Olatoyosi M. Odenike Ph: 773-834-7424
 Olatoyosi M. OdenikePrincipal Investigator
 University of Illinois Cancer Center
 John G. Quigley Ph: 312-355-3046
 John G. QuigleyPrincipal Investigator
  Decatur
 Decatur Memorial Hospital Cancer Care Institute
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
 James L. WadePrincipal Investigator
  Eureka
 Illinois CancerCare - Eureka
 Nguyet A. Le-Lindqwister Ph: 800-793-2262
 Nguyet A. Le-LindqwisterPrincipal Investigator
  Evanston
 CCOP - Evanston
 Lynne S. Kaminer Ph: 847-570-1381
 Lynne S. KaminerPrincipal Investigator
  Havana
 Illinois CancerCare - Havana
 Nguyet A. Le-Lindqwister Ph: 800-793-2262
 Nguyet A. Le-LindqwisterPrincipal Investigator
  Kewanee
 Illinois CancerCare - Kewanee Clinic
 Nguyet A. Le-Lindqwister Ph: 800-793-2262
 Nguyet A. Le-LindqwisterPrincipal Investigator
  Macomb
 Illinois CancerCare - Macomb
 Nguyet A. Le-Lindqwister Ph: 800-793-2262
 Nguyet A. Le-LindqwisterPrincipal Investigator
  Maywood
 Cardinal Bernardin Cancer Center at Loyola University Medical Center
 Danielle A. Shafer Ph: 708-226-4357
 Danielle A. ShaferPrincipal Investigator
  Moline
 Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
 Costas L. Constantinou Ph: 319-363-2690
 Costas L. ConstantinouPrincipal Investigator
  Monmouth
 Illinois CancerCare - Monmouth
 Nguyet A. Le-Lindqwister Ph: 800-793-2262
 Nguyet A. Le-LindqwisterPrincipal Investigator
  Normal
 Illinois CancerCare - Community Cancer Center
 Nguyet A. Le-Lindqwister Ph: 800-793-2262
 Nguyet A. Le-LindqwisterPrincipal Investigator
  Ottawa
 Illinois CancerCare - Ottawa
 Nguyet A. Le-Lindqwister Ph: 800-793-2262
 Nguyet A. Le-LindqwisterPrincipal Investigator
  Pekin
 Illinois CancerCare - Pekin
 Nguyet A. Le-Lindqwister Ph: 800-793-2262
 Nguyet A. Le-LindqwisterPrincipal Investigator
  Peoria
 CCOP - Illinois Oncology Research Association
 Nguyet A. Le-Lindqwister Ph: 800-793-2262
 Nguyet A. Le-LindqwisterPrincipal Investigator
 Illinois CancerCare - Peoria
 Nguyet A. Le-Lindqwister Ph: 800-793-2262
 Nguyet A. Le-LindqwisterPrincipal Investigator
  Peru
 Illinois CancerCare - Peru
 Nguyet A. Le-Lindqwister Ph: 800-793-2262
 Nguyet A. Le-LindqwisterPrincipal Investigator
  Princeton
 Illinois CancerCare - Princeton
 Nguyet A. Le-Lindqwister Ph: 800-793-2262
 Nguyet A. Le-LindqwisterPrincipal Investigator
  Rockford
 Swedish-American Regional Cancer Center
 Harvey E. Einhorn Ph: 815-489-4413
 Harvey Eric EinhornPrincipal Investigator
  Springfield
 Regional Cancer Center at Memorial Medical Center
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
 James L. WadePrincipal Investigator
Indiana
  Merrillville
 Premier Oncology Hematology Associates
 Bharat H. Barai Ph: 219-736-2800
 Bharat H. BaraiPrincipal Investigator
Iowa
  Ames
 McFarland Clinic, PC
 Joseph J. Merchant Ph: 515-239-2621
 Joseph J. MerchantPrincipal Investigator
  Iowa City
 Holden Comprehensive Cancer Center at University of Iowa
 Thomas H. Carter Ph: 800-237-1225
 Thomas H. CarterPrincipal Investigator
  Sioux City
 Siouxland Hematology-Oncology Associates, LLP
 Donald B. Wender Ph: 712-252-0088
 Donald B. WenderPrincipal Investigator
  Waterloo
 Covenant Cancer Treatment Center
 Mohammed T. Masri Ph: 319-272-2070
 Mohammed T. MasriPrincipal Investigator
Kansas
  Prairie Village
 Kansas City CCOP
 Rakesh Gaur Ph: 913-948-5588
  Email: amy.krushelniski@hcahealthcare.com
 Rakesh GaurPrincipal Investigator
  Topeka
 Cotton-O'Neil Cancer Center
 David E. Einspahr Ph: 785-270-4963
 David E. EinspahrPrincipal Investigator
Kentucky
  Lexington
 Lucille P. Markey Cancer Center at University of Kentucky
 Dianna S. Howard Ph: 859-257-3379
 Dianna S. HowardPrincipal Investigator
Louisiana
  Shreveport
 Feist-Weiller Cancer Center at Louisiana State University Health Sciences
 Nebu V. Koshy Ph: 318-813-1412
 Nebu V. KoshyPrincipal Investigator
Maine
  Bangor
 CancerCare of Maine at Eastern Maine Medical Center
 Thomas H. Openshaw Ph: 207-973-4274
 Thomas H. OpenshawPrincipal Investigator
Maryland
  Baltimore
 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
 Steven D. Gore Ph: 410-955-8804
  Email: jhcccro@jhmi.edu
 Steven D. GorePrincipal Investigator
  Elkton MD
 Union Hospital of Cecil County
 Stephen S. Grubbs Ph: 302-733-6227
 Stephen S. GrubbsPrincipal Investigator
Massachusetts
  Boston
 Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
 David P. Steensma Ph: 866-790-4500
 David P. SteensmaPrincipal Investigator
 Massachusetts General Hospital
 David P. Steensma Ph: 866-790-4500
 David P. SteensmaPrincipal Investigator
  Springfield
 Baystate Regional Cancer Program at D'Amour Center for Cancer Care
 Syed S. Ali Ph: 413-794-3565
  Email: tamara.wrenn@baystatehealth.org
 Syed S. AliPrincipal Investigator
  Worcester
 UMASS Memorial Cancer Center - University Campus
 Muthalagu Ramanathan Ph: 508-856-2464
  Email: laura.lefko@umassmed.edu
 Muthalagu RamanathanPrincipal Investigator
Michigan
  Ann Arbor
 Saint Joseph Mercy Cancer Center
 Christopher M. Reynolds Ph: 734-712-3456
 Christopher M. ReynoldsPrincipal Investigator
  Detroit
 Barbara Ann Karmanos Cancer Institute
 Jay Yang Ph: 313-576-9363
 Jay YangPrincipal Investigator
  Escanaba
 Green Bay Oncology, Limited - Escanaba
 Matthew L. Ryan Ph: 800-432-6049
 Matthew L. RyanPrincipal Investigator
  Grand Rapids
 Grand Rapids Clinical Oncology Program
 Gilbert D. Padula Ph: 616-685-5225
 Gilbert D. PadulaPrincipal Investigator
  Iron Mountain
 Dickinson County Healthcare System
 Matthew L. Ryan Ph: 800-432-6049
 Matthew L. RyanPrincipal Investigator
  Kalamazoo
 West Michigan Cancer Center
 Raymond S. Lord Ph: 269-373-7458
 Raymond S. LordPrincipal Investigator
  Traverse City
 Munson Medical Center
 Gilbert D. Padula Ph: 616-685-5225
 Gilbert D. PadulaPrincipal Investigator
Minnesota
  Bemidji
 Sanford Clinic North-Bemidgi
 Preston D. Steen Ph: 701-234-6161
 Preston D. SteenPrincipal Investigator
  Burnsville
 Fairview Ridges Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Patrick J. FlynnPrincipal Investigator
  Coon Rapids
 Mercy and Unity Cancer Center at Mercy Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Patrick J. FlynnPrincipal Investigator
  Edina
 Fairview Southdale Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Patrick J. FlynnPrincipal Investigator
  Fridley
 Mercy and Unity Cancer Center at Unity Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Patrick J. FlynnPrincipal Investigator
  Hutchinson
 Hutchinson Area Health Care
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Patrick J. FlynnPrincipal Investigator
  Maplewood
 HealthEast Cancer Care at St. John's Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Patrick J. FlynnPrincipal Investigator
 Minnesota Oncology - Maplewood
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Patrick J. FlynnPrincipal Investigator
  Minneapolis
 Hennepin County Medical Center - Minneapolis
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Patrick J. FlynnPrincipal Investigator
 Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Patrick J. FlynnPrincipal Investigator
  Robbinsdale
 Humphrey Cancer Center at North Memorial Outpatient Center
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Patrick J. FlynnPrincipal Investigator
  Rochester
 Mayo Clinic Cancer Center
 Mrinal M. Patnaik Ph: 507-538-7623
 Mrinal M. PatnaikPrincipal Investigator
  Saint Cloud
 CentraCare Clinic - River Campus
 Donald J. Jurgens Ph: 877-229-4907
  Email: coborncancercenter@centracare.com
 Donald J. JurgensPrincipal Investigator
  Saint Louis Park
 CCOP - Metro-Minnesota
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Patrick J. FlynnPrincipal Investigator
 Park Nicollet Cancer Center
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Patrick J. FlynnPrincipal Investigator
  Saint Paul
 Regions Hospital Cancer Care Center
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Patrick J. FlynnPrincipal Investigator
 United Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Patrick J. FlynnPrincipal Investigator
  Shakopee
 St. Francis Cancer Center at St. Francis Medical Center
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Patrick J. FlynnPrincipal Investigator
  Stillwater
 Lakeview Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Patrick J. FlynnPrincipal Investigator
  Waconia
 Ridgeview Medical Center
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Patrick J. FlynnPrincipal Investigator
  Willmar
 Willmar Cancer Center at Rice Memorial Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Patrick J. FlynnPrincipal Investigator
  Woodbury
 Minnesota Oncology - Woodbury
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Patrick J. FlynnPrincipal Investigator
Mississippi
  Jackson
 University of Mississippi Cancer Clinic
 Stephanie L. Elkins Ph: 601-815-6700
 Stephanie L. ElkinsPrincipal Investigator
Missouri
  Columbia
 Ellis Fischel Cancer Center at University of Missouri - Columbia
 Carl E. Freter Ph: 573-882-7440
 Carl E. FreterPrincipal Investigator
  Kansas City
 Saint Luke's Cancer Institute at Saint Luke's Hospital
 Rakesh Gaur Ph: 913-948-5588
  Email: amy.krushelniski@hcahealthcare.com
 Rakesh GaurPrincipal Investigator
  Saint Louis
 David C. Pratt Cancer Center at St. John's Mercy
 Bethany G. Sleckman Ph: 913-948-5588
 Bethany G. SleckmanPrincipal Investigator
Montana
  Billings
 Billings Clinic Cancer Center
 Benjamin T. Marchello Ph: 800-648-6274
 Benjamin T. MarchelloPrincipal Investigator
  Bozeman
 Bozeman Deaconess Cancer Center
 Benjamin T. Marchello Ph: 800-648-6274
 Benjamin T. MarchelloPrincipal Investigator
New Jersey
  Camden
 Cancer Institute of New Jersey at Cooper University Hospital - Camden
 Stephen S. Grubbs Ph: 302-733-6227
 Stephen S. GrubbsPrincipal Investigator
New Mexico
  Albuquerque
 Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital
 Elizabeth A. McGuire Ph: 505-727-8000
 Elizabeth A. McGuirePrincipal Investigator
 University of New Mexico Cancer Center
 Elizabeth A. McGuire Ph: 505-727-8000
 Elizabeth A. McGuirePrincipal Investigator
New York
  Bronx
 Albert Einstein Cancer Center at Albert Einstein College of Medicine
 Amit K. Verma Ph: 718-904-2730
  Email: aecc@aecom.yu.edu
 Amit K. VermaPrincipal Investigator
 Amit K. Verma Ph: 718-904-2730
  Email: aecc@aecom.yu.edu
 Amit K. VermaPrincipal Investigator
  Buffalo
 Roswell Park Cancer Institute
 Eunice S. Wang Ph: 877-275-7724
 Eunice WangPrincipal Investigator
  Lake Success
 Monter Cancer Center of the North Shore-LIJ Health System
 Cristina M. Ghiuzeli Ph: 516-562-3467
 Cristina M. GhiuzeliPrincipal Investigator
  Manhasset
 Don Monti Comprehensive Cancer Center at North Shore University Hospital
 Cristina M. Ghiuzeli Ph: 516-562-3467
 Cristina M. GhiuzeliPrincipal Investigator
  New York
 New York Weill Cornell Cancer Center at Cornell University
 Gail J. Roboz Ph: 212-746-1848
 Gail J. RobozPrincipal Investigator
  Rochester
 James P. Wilmot Cancer Center at University of Rochester Medical Center
 Jonathan W. Friedberg Ph: 585-275-5830
 Jonathan W. FriedbergPrincipal Investigator
North Carolina
  Asheboro
 Randolph Hospital
 Peter Rubin Ph: 336-832-0821
 Peter RubinPrincipal Investigator
  Goldsboro
 Wayne Memorial Hospital, Incorporated
 James N. Atkins Ph: 919-580-0000
 James N. AtkinsPrincipal Investigator
  Greensboro
 Moses Cone Health System-Regional Cancer Center
 Peter Rubin Ph: 336-832-0821
 Peter RubinPrincipal Investigator
  Hendersonville
 Pardee Memorial Hospital
 James E. Radford Ph: 828-696-4716
 James E. RadfordPrincipal Investigator
  Kinston
 Kinston Medical Specialists
 Peter R. Watson Ph: 252-559-2200
 Peter R. WatsonPrincipal Investigator
  Pinehurst
 FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
 Charles S. Kuzma Ph: 910-715-2200
 Charles S. KuzmaPrincipal Investigator
  Reidsville
 Annie Penn Memorial Hospital
 Peter Rubin Ph: 336-832-0821
 Peter RubinPrincipal Investigator
  Statesville
 Iredell Memorial Hospital
 Ruby A. Grimm Ph: 704-873-5661
 Ruby A. GrimmPrincipal Investigator
North Dakota
  Bismarck
 Sanford Bismarck Medical Center
 Edward J. Wos Ph: 701-323-5760
  Email: tfischer@mohs.org
 Edward J. WosPrincipal Investigator
  Fargo
 Roger Maris Cancer Center at MeritCare Hospital
 Preston D. Steen Ph: 701-234-6161
 Preston D. SteenPrincipal Investigator
 Sanford Clinic North-Fargo
 Preston D. Steen Ph: 701-234-6161
 Preston D. SteenPrincipal Investigator
 Sanford Medical Center-Fargo
 Preston D. Steen Ph: 701-234-6161
 Preston D. SteenPrincipal Investigator
Ohio
  Beachwood
 Cleveland Clinic Beachwood Family Health and Surgery Center
 Anjali S. Advani Ph: 866-223-8100
 Anjali S. AdvaniPrincipal Investigator
  Cleveland
 Case Comprehensive Cancer Center
 Brenda W. Cooper Ph: 800-641-2422
 Brenda W. CooperPrincipal Investigator
 Cleveland Clinic Cancer Center/Fairview Hospital
 Anjali S. Advani Ph: 866-223-8100
 Anjali S. AdvaniPrincipal Investigator
 Cleveland Clinic Taussig Cancer Center
 Anjali S. Advani Ph: 866-223-8100
 Anjali S. AdvaniPrincipal Investigator
  Independence
 Cleveland Clinic Cancer Center
 Anjali S. Advani Ph: 866-223-8100
 Anjali S. AdvaniPrincipal Investigator
  Mayfield Heights
 Hillcrest Cancer Center at Hillcrest Hospital
 Anjali S. Advani Ph: 866-223-8100
 Anjali S. AdvaniPrincipal Investigator
  Parma
 Parma Community General Hospital
 Anjali S. Advani Ph: 866-223-8100
 Anjali S. AdvaniPrincipal Investigator
  Sandusky
 North Coast Cancer Care, Incorporated
 Anjali S. Advani Ph: 866-223-8100
 Anjali S. AdvaniPrincipal Investigator
  Strongsville
 Cleveland Clinic Cancer Center-Strongsville
 Anjali S. Advani Ph: 866-223-8100
 Anjali S. AdvaniPrincipal Investigator
  Toledo
 University of Toledo Medical Center
 Rex B. Mowat Ph: 517-265-0116
 Rex B. MowatPrincipal Investigator
  Wooster
 Cleveland Clinic - Wooster
 Anjali S. Advani Ph: 866-223-8100
 Anjali S. AdvaniPrincipal Investigator
Oklahoma
  Norman
 Cancer Care Associates-Norman
 Vikki A. Canfield Ph: 888-823-5923
  Email: ctsucontact@westat.com
 Vikki A. CanfieldPrincipal Investigator
  Oklahoma City
 Cancer Care Associates-Mercy
 Vikki A. Canfield Ph: 888-823-5923
  Email: ctsucontact@westat.com
 Vikki A. CanfieldPrincipal Investigator
 Oklahoma University Cancer Institute
 George B. Selby Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
 George B. SelbyPrincipal Investigator
Oregon
  Milwaukie
 Providence Milwaukie Hospital
 Alison K. Conlin Ph: 503-215-6412
 Alison K. ConlinPrincipal Investigator
  Newberg
 Providence Newberg Medical Center
 Alison K. Conlin Ph: 503-215-6412
 Alison K. ConlinPrincipal Investigator
  Oregon City
 Providence Willamette Falls Medical Center
 Alison K. Conlin Ph: 503-215-6412
 Alison K. ConlinPrincipal Investigator
  Portland
 Legacy Good Samaritan Hospital & Comprehensive Cancer Center
 Jacqueline Vuky Ph: 503-299-6500
 Jacqueline VukyPrincipal Investigator
 Providence Cancer Center at Providence Portland Medical Center
 Alison K. Conlin Ph: 503-215-6412
 Alison K. ConlinPrincipal Investigator
 Providence St. Vincent Medical Center
 Alison K. Conlin Ph: 503-215-6412
 Alison K. ConlinPrincipal Investigator
Pennsylvania
  Allentown
 Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
 Eliot L. Friedman Ph: 610-402-2273
 Eliot L. FriedmanPrincipal Investigator
  Doylestown
 Doylestown Hospital Cancer Center
 Mitchell B. Alden Ph: 215-345-2378
  Email: lheacock@dh.org
 Mitchell B. AldenPrincipal Investigator
  West Reading
 McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
 Terrence P. Cescon Ph: 610-988-9323
 Terrence P. CesconPrincipal Investigator
South Carolina
  Greenville
 Batson Cancer Care Center at St. Francis Hospital
 James D. Bearden Ph: 800-486-5941
 James D. BeardenPrincipal Investigator
 Cancer Centers of the Carolinas - Faris
 Jeffrey K. Giguere Ph: 864-241-6251
 Jeffrey K. GiguerePrincipal Investigator
 Cancer Centers of the Carolinas - Grove Commons
 Jeffrey K. Giguere Ph: 864-241-6251
 Jeffrey K. GiguerePrincipal Investigator
 CCOP - Greenville
 Jeffrey K. Giguere Ph: 864-241-6251
 Jeffrey K. GiguerePrincipal Investigator
 Greenville Hospital Cancer Center
 Jeffrey K. Giguere Ph: 864-241-6251
 Jeffrey K. GiguerePrincipal Investigator
  Greer
 Cancer Centers of the Carolinas-Greer Medical Oncology
 Jeffrey K. Giguere Ph: 864-241-6251
 Jeffrey K. GiguerePrincipal Investigator
  Seneca
 Cancer Centers of the Carolinas - Seneca
 Jeffrey K. Giguere Ph: 864-241-6251
 Jeffrey K. GiguerePrincipal Investigator
  Spartanburg
 Cancer Centers of the Carolinas - Spartanburg
 Jeffrey K. Giguere Ph: 864-241-6251
 Jeffrey K. GiguerePrincipal Investigator
 CCOP - Upstate Carolina
 James D. Bearden Ph: 800-486-5941
 James D. BeardenPrincipal Investigator
 Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
 James D. Bearden Ph: 800-486-5941
 James D. BeardenPrincipal Investigator
South Dakota
  Rapid City
 Rapid City Regional Hospital
 Mark T. Schroeder Ph: 605-716-3982
  Email: research@rcrh.org
 Mark T. SchroederPrincipal Investigator
  Sioux Falls
 Sanford Cancer Center at Sanford USD Medical Center
 Miroslaw A. Mazurczak Ph: 605-328-1367
 Miroslaw A. MazurczakPrincipal Investigator
 Sanford USD Medical Center - Sioux Falls
 Miroslaw A. Mazurczak Ph: 605-328-1367
 Miroslaw A. MazurczakPrincipal Investigator
Tennessee
  Knoxville
 Thompson Cancer Survival Center
 Samuel S. McCachren Ph: 865-541-1812
 Samuel S. McCachrenPrincipal Investigator
Texas
  Amarillo
 Harrington Cancer Center
 Stewart A. Sharp Ph: 806-359-4673
  Email: ryokubaitis@harringtoncc.org
 Stewart A. SharpPrincipal Investigator
Utah
  Salt Lake City
 Huntsman Cancer Institute at University of Utah
 Paul J. Shami Ph: 801-581-4477
  Email: clinical.trials@hci.utah.edu
 Paul J. ShamiPrincipal Investigator
Washington
  Vancouver
 PeaceHealth Southwest Medical Center
 Alison K. Conlin Ph: 503-215-6412
 Alison K. ConlinPrincipal Investigator
Wisconsin
  Eau Claire
 Marshfield Clinic Cancer Care at Regional Cancer Center
 Ali W. Bseiso Ph: 715-389-4457
 Ali W. BseisoPrincipal Investigator
  Green Bay
 Green Bay Oncology, Limited at St. Mary's Hospital
 Matthew L. Ryan Ph: 800-432-6049
 Matthew L. RyanPrincipal Investigator
 Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
 Matthew L. Ryan Ph: 800-432-6049
 Matthew L. RyanPrincipal Investigator
 St. Mary's Hospital Medical Center - Green Bay
 Matthew L. Ryan Ph: 800-432-6049
 Matthew L. RyanPrincipal Investigator
 St. Vincent Hospital Regional Cancer Center
 Matthew L. Ryan Ph: 800-432-6049
 Matthew L. RyanPrincipal Investigator
 Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
 Dhimant R. Patel Ph: 800-252-2990
 Dhimant R. PatelPrincipal Investigator
  Janesville
 Mercy Regional Cancer Center
 Emily G. Robinson Ph: 800-928-1103
 Emily G. RobinsonPrincipal Investigator
  La Crosse
 Gundersen Lutheran Center for Cancer and Blood
 Kurt Oettel Ph: 608-775-2385
  Email: cancerctr@gundluth.org
 Kurt OettelPrincipal Investigator
  Madison
 Dean Hematology & Oncology Clinic
 Amit Sanyal Ph: 608-410-2700
 Amit SanyalPrincipal Investigator
  Marinette
 Vince Lombardi Cancer Clinic - Marinette
 Dhimant R. Patel Ph: 800-252-2990
 Dhimant R. PatelPrincipal Investigator
  Marshfield
 Marshfield Clinic - Marshfield Center
 Ali W. Bseiso Ph: 715-389-4457
 Ali W. BseisoPrincipal Investigator
  Milwaukee
 Froedtert Hospital and Medical College of Wisconsin
 Ehab L. Atallah Ph: 414-805-4380
 Ehab L. AtallahPrincipal Investigator
  Oconomowoc
 Regional Cancer Center at Oconomowoc Memorial Hospital
 Michael A. Thompson Ph: 262-928-7632
 Michael A. ThompsonPrincipal Investigator
  Oconto Falls
 Green Bay Oncology, Limited - Oconto Falls
 Matthew L. Ryan Ph: 800-432-6049
 Matthew L. RyanPrincipal Investigator
  Rhinelander
 Ministry Medical Group at Saint Mary's Hospital
 Ali W. Bseiso Ph: 715-389-4457
 Ali W. BseisoPrincipal Investigator
  Rice Lake
 Marshfield Clinic - Indianhead Center
 Ali W. Bseiso Ph: 715-389-4457
 Ali W. BseisoPrincipal Investigator
  Stevens Point
 Marshfield Clinic Cancer Care at Saint Michael's Hospital
 Ali W. Bseiso Ph: 715-389-4457
 Ali W. BseisoPrincipal Investigator
 Saint Michael's Hospital Cancer Center
 Ali W. Bseiso Ph: 715-389-4457
 Ali W. BseisoPrincipal Investigator
  Sturgeon Bay
 Green Bay Oncology, Limited - Sturgeon Bay
 Matthew L. Ryan Ph: 800-432-6049
 Matthew L. RyanPrincipal Investigator
  Summit
 Aurora Medical Center in Summit
 Dhimant R. Patel Ph: 800-252-2990
 Dhimant R. PatelPrincipal Investigator
  Waukesha
 Waukesha Memorial Hospital Regional Cancer Center
 Michael A. Thompson Ph: 262-928-7632
 Michael A. ThompsonPrincipal Investigator
  Wauwatosa
 Aurora Cancer Care-Milwaukee West
 Rubina Qamar Ph: 888-709-2080
 Rubina QamarPrincipal Investigator
  Weston
 Marshfield Clinic - Weston Center
 Ali W. Bseiso Ph: 715-389-4457
 Ali W. BseisoPrincipal Investigator
  Wisconsin Rapids
 Marshfield Clinic - Wisconsin Rapids Center
 Ali W. Bseiso Ph: 715-389-4457
 Ali W. BseisoPrincipal Investigator
Canada
Ontario
  Toronto
 Odette Cancer Centre at Sunnybrook
 Rena J. Buckstein Ph: 416-480-5000
 Rena J. BucksteinPrincipal Investigator

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

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

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