Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

Azacitidine With or Without Entinostat in Treating Patients With Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia

Basic Trial Information

Objectives

Primary

1. Compare the overall response rate (complete, partial, and hematologic improvement-major by International Working Group [IWG] criteria) in patients with treatment-induced or non-treatment-induced myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (dysplastic), or acute myeloid leukemia with multilineage dysplasia treated with azacitidine with vs without entinostat.
2. Compare the major response rate (complete and partial responses by IWG criteria) in patients treated with these regimens.

Secondary

1. Evaluate the toxicity of azacitidine and entinostatin these patients.
2. Identify changes in gene promoter methylation and gene expression that may be associated with response to azacitidine and entinostat.
3. Identify other molecular mechanisms (such as DNA damage) that may be associated with response to azacitidine and entinostat.

Entry Criteria

Disease Characteristics:

• Bone marrow aspirate and/or biopsy-confirmed diagnosis of 1 of the following:
  • Myelodysplastic syndromes (MDS)
    • Any International Prognostic Score (IPSS) eligible
      • Patients with low or intermediate-1 IPSS must have platelet count < 50,000/mm³ and/or absolute neutrophil count < 500/mm³
    • Blast count < 20%
  • Chronic myelomonocytic leukemia (dysplastic subtype)
    • WBC < 12,000/mm³ (measured twice within the past 4 weeks, 2 weeks apart)
  • Acute myeloid leukemia with multilineage dysplasia (AML-TLD)
    • Formerly diagnosed refractory anemia with excess blasts in transformation by FAB criteria allowed
    • AML-TLD by WHO criteria allowed in patients with no history of antecedent hematologic disorder
    • WBC ≤ 30,000/mm³ (measured twice within the past 4 weeks, 2 weeks apart)
      • WBC that has doubled over 4 weeks AND > 20,000/mm³ is not eligible
    • Evidence of ≥ 20% blasts on review of the bone marrow aspirate and/or biopsy

• SWOG patients must be enrolled in research study trial SWOG-9007

• Therapy-induced MDS, AML-TLD, or chronic myelomonocytic leukemia (dysplastic subtype) allowed

• No clinical evidence of CNS or pulmonary leukostasis or disseminated intravascular coagulation

• No clinical evidence of CNS leukemia

Prior/Concurrent Therapy:

• Recovered from prior therapy
• No prior azacitidine, decitabine or entinostat
• No prior induction chemotherapy for AML or stem cell transplantation
• No hematopoietic growth factors within 3 weeks prior to study entry
• No other concurrent investigational or commercial agents or therapies for the malignancy
• No concurrent valproic acid, epoetin alfa, or darbepoetin alfa
• No filgrastim (G-CSF) or pegfilgrastim during days 1-10 of each treatment course

Patient Characteristics:

• See Disease Characteristics
• ECOG performance status 0-2
• Life expectancy ≥ 6 months
• Creatinine < 2.0 mg/dL
• Bilirubin normal (unless due to intramedullary or extramedullary hemolysis, or Gilbert's syndrome)
• AST and ALT ≤ 2.5 times upper limit of normal
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No active infections
• No advanced malignant hepatic tumors
• No other serious or uncontrolled medical conditions
• No known hypersensitivity to azacitidine or mannitol

Expected Enrollment

A total of 196 patients will be accrued for this study.

Outcomes

The complete response rate, partial response rate, and trilineage response rate

Overall response rate (complete response and partial response)
Toxicity
Clinical mechanism of azacitidine with or without entinostat as measured by methylation-specific real time PCR (MSP) assay

Outline

This is a randomized, multicenter study. Patients are first stratified according to treatment-related disease (yes vs no), followed by a second stratification according to disease (myelodysplastic syndromes [MDS] high/intermediate-2 vs MDS low/intermediate-1 vs chronic myelomonocytic leukemia vs acute myeloid leukemia with multilineage dysplasia). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive azacitidine subcutaneously once daily on days 1-10.

• Arm II: Patients receive azacitidine as in arm I and oral entinostat on days 3 and 10.

Treatment in both arms repeats every 28 days for at least 6 and up to 24 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 5 years.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Steven Gore, MD, Protocol chair		Ph: 410-955-8781 Email: gorest@jhmi.edu
Peter Greenberg, MD, Protocol co-chair		Ph: 650-725-8355; 800-756-9000 Email: peterg@stanford.edu

U.S.A.
Arizona
	Scottsdale
	Mayo Clinic Scottsdale
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
California
	Burbank
	Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
		Clinical Trials Office - Providence Saint Joseph Medical Center - Burbank	Ph:  818-847-3220
	Stanford
	Stanford Cancer Center
		Clinical Trials Office - Stanford Cancer Center	Ph:  650-498-7061
			Email: cctoffice@stanford.edu
Colorado
	Aurora
	Aurora Presbyterian Hospital
		Eduardo Pajon, MD	Ph:  303-399-8020ext2261
	Boulder
	Boulder Community Hospital
		Clinical Trials Office - Boulder Community Hospital	Ph:  303-938-5253
	Colorado Springs
	Penrose Cancer Center at Penrose Hospital
		Clinical Trials Office - Penrose Cancer Center	Ph:  719-776-5275
	Denver
	CCOP - Colorado Cancer Research Program
		Eduardo Pajon, MD	Ph:  303-399-8020ext2261
	Porter Adventist Hospital
		Eduardo Pajon, MD	Ph:  303-399-8020ext2261
	Presbyterian - St. Luke's Medical Center
		Clinical Trials Office - Presbyterian - St. Luke's Medical Center	Ph:  303-839-6000
	Rose Medical Center
		Eduardo Pajon, MD	Ph:  303-399-8020ext2261
	St. Anthony Central Hospital
		Eduardo Pajon, MD	Ph:  303-399-8020ext2261
	St. Joseph Hospital
		Eduardo Pajon, MD	Ph:  303-399-8020ext2261
	Englewood
	Swedish Medical Center
		Eduardo Pajon, MD	Ph:  303-399-8020ext2261
	Fort Collins
	Front Range Cancer Specialists
		Robert Marschke, Jr.	Ph:  970-212-7600
	Poudre Valley Hospital
		Clinical Trials Office - Poudre Valley Hospital	Ph:  970-495-8226
	Grand Junction
	St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
		Eduardo Pajon, MD	Ph:  303-399-8020ext2261
	Greeley
	North Colorado Medical Center
		Eduardo Pajon, MD	Ph:  303-399-8020ext2261
	Lone Tree
	Sky Ridge Medical Center
		Eduardo Pajon, MD	Ph:  303-399-8020ext2261
	Longmont
	Hope Cancer Care Center at Longmont United Hospital
		Eduardo Pajon, MD	Ph:  303-399-8020ext2261
	Loveland
	McKee Medical Center
		Eduardo Pajon, MD	Ph:  303-399-8020ext2261
	Pueblo
	St. Mary - Corwin Regional Medical Center
		Eduardo Pajon, MD	Ph:  303-399-8020ext2261
	Thornton
	North Suburban Medical Center
		Eduardo Pajon, MD	Ph:  303-399-8020ext2261
	Wheat Ridge
	Exempla Lutheran Medical Center
		Clinical Trials Office - Exempla Lutheran Medical Center	Ph:  303-403-3605
Connecticut
	Norwalk
	Norwalk Hospital
		Richard Frank, MD	Ph:  203-845-2132
Delaware
	Lewes
	Tunnell Cancer Center at Beebe Medical Center
		Clinical Trials Office - Tunnell Cancer Center	Ph:  302-645-3171
	Newark
	CCOP - Christiana Care Health Services
		Clinical Trial Office - CCOP - Christiana Care Health Services	Ph:  302-623-4450
Illinois
	Bloomington%
	Illinois CancerCare - Bloomington
		John Kugler, MD	Ph:  309-243-3605
	Canton
	Graham Hospital
		John Kugler, MD	Ph:  309-243-3605
	Illinois CancerCare - Canton
		John Kugler, MD	Ph:  309-243-3605
	Carthage
	Memorial Hospital
		John Kugler, MD	Ph:  309-243-3605
	Chicago
	Hematology and Oncology Associates
		Clinical Trails Office - Hematology and Oncology Associates	Ph:  312-695-1301
	Robert H. Lurie Comprehensive Cancer Center at Northwestern University
		Clinical Trials Office - Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Ph:  312-695-1301
			Email: cancer@northwestern.edu
	University of Illinois Cancer Center
		Clinical Trial Office - University of Illinois Cancer Center	Ph:  312-355-3046
	Decatur
	Decatur Memorial Hospital Cancer Care Institute
		Clinical Trials Office - Decatur Memorial Hospital Cancer Care Institute	Ph:  217-876-4750
	Eureka
	Eureka Community Hospital
		John Kugler, MD	Ph:  309-243-3605
	Illinois CancerCare - Eureka
		John Kugler, MD	Ph:  309-243-3605
	Evanston
	Evanston Hospital
		Clinical Trials Office - Evanston Hospital	Ph:  847-570-1381
	Galesburg
	Galesburg Clinic, PC
		John Kugler, MD	Ph:  309-243-3605
	Illinois CancerCare - Galesburg
		John Kugler, MD	Ph:  309-243-3605
	Havana
	Mason District Hospital
		John Kugler, MD	Ph:  309-243-3605
	Hinsdale
	Hinsdale Hematology Oncology Associates
		Elyse Schneiderman, MD	Ph:  630-654-1790
	Joliet
	Midwest Center for Hematology/Oncology
		Olga Frankfurt	Ph:  815-740-1400
	Libertyville
	North Shore Oncology and Hematology Associates, Limited - Libertyville
		Olga Frankfurt	Ph:  847-367-6781
	Macomb
	Illinois CancerCare - Macomb
		John Kugler, MD	Ph:  309-243-3605
	McDonough District Hospital
		John Kugler, MD	Ph:  309-243-3605
	Maywood
	Cardinal Bernardin Cancer Center at Loyola University Medical Center
		Clinical Trials Office - Cardinal Bernardin Cancer Center	Ph:  708-226-4357
	Niles
	Cancer Care and Hematology Specialists of Chicagoland - Niles
		Olga Frankfurt	Ph:  847-827-9060
	Normal
	BroMenn Regional Medical Center
		John Kugler, MD	Ph:  309-243-3605
	Community Cancer Center
		John Kugler, MD	Ph:  309-243-3605
	Illinois CancerCare - Community Cancer Center
		John Kugler, MD	Ph:  309-243-3605
	Ottawa
	Community Hospital of Ottawa
		John Kugler, MD	Ph:  309-243-3605
	Oncology Hematology Associates of Central Illinois, PC - Ottawa
		John Kugler, MD	Ph:  309-243-3605
	Pekin
	Cancer Treatment Center at Pekin Hospital
		John Kugler, MD	Ph:  309-243-3605
	Illinois CancerCare - Pekin
		John Kugler, MD	Ph:  309-243-3605
	Peoria
	CCOP - Illinois Oncology Research Association
		John Kugler, MD	Ph:  309-243-3605
	Methodist Medical Center of Illinois
		Clinical Trials Office - Methodist Medical Center of Illinois	Ph:  309-243-3000
	Oncology Hematology Associates of Central Illinois, PC - Peoria
		John Kugler, MD	Ph:  309-243-3605
	Proctor Hospital
		John Kugler, MD	Ph:  309-243-3605
	Peru
	Illinois CancerCare - Peru
		John Kugler, MD	Ph:  309-243-3605
	Illinois Valley Community Hospital
		John Kugler, MD	Ph:  309-243-3605
	Princeton
	Perry Memorial Hospital
		John Kugler, MD	Ph:  309-243-3605
	Rockford
	Swedish-American Regional Cancer Center
		Clinical Trials Office - Swedish-American Regional Cancer Center	Ph:  815-489-4413
	Skokie
	Hematology Oncology Associates - Skokie
		Olga Frankfurt	Ph:  847-568-9930
	Spring Valley
	Illinois CancerCare - Spring Valley
		John Kugler, MD	Ph:  309-243-3605
	Springfield
	Regional Cancer Center at Memorial Medical Center
		Clinical Trials Office - Regional Cancer Center at Memorial Medical Center	Ph:  217-788-4233
Indiana
	Fort Wayne
	Fort Wayne Medical Oncology and Hematology
		Sreenivasa Nattam, MD	Ph:  260-484-8830
Iowa
	Ames
	McFarland Clinic, PC
		Clinical Trials Office - McFarland Clinic, PC	Ph:  515-239-2621
	Iowa City
	Holden Comprehensive Cancer Center at University of Iowa
		Cancer Information Service	Ph:  800-237-1225
	Ottumwa
	McCreery Cancer Center at Ottumwa Regional
		Robert Behrens	Ph:  641-684-2946
	Sioux City
	Mercy Medical Center - Sioux City
		Donald Wender, MD, PhD	Ph:  712-252-0088
	Siouxland Hematology-Oncology Associates, LLP
		Donald Wender, MD, PhD	Ph:  712-252-0088
	St. Luke's Regional Medical Center
		Donald Wender, MD, PhD	Ph:  712-252-0088
Kansas
	Chanute
	Cancer Center of Kansas, PA - Chanute
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Dodge City
	Cancer Center of Kansas, PA - Dodge City
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	El Dorado
	Cancer Center of Kansas, PA - El Dorado
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Fort Scott
	Cancer Center of Kansas - Fort Scott
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Independence
	Cancer Center of Kansas-Independence
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Kingman
	Cancer Center of Kansas, PA - Kingman
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Lawrence
	Lawrence Memorial Hospital
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Liberal
	Cancer Center of Kansas, PA - Liberal
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Newton
	Cancer Center of Kansas, PA - Newton
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Overland Park
	Menorah Medical Center
		Rakesh Gaur, MD	Ph:  816-823-0555
	Saint Luke's Hospital - South
		Rakesh Gaur, MD	Ph:  816-823-0555
	Parsons
	Cancer Center of Kansas, PA - Parsons
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Pratt
	Cancer Center of Kansas, PA - Pratt
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Salina
	Cancer Center of Kansas, PA - Salina
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Wellington
	Cancer Center of Kansas, PA - Wellington
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Wichita
	Associates in Womens Health, PA - North Review
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Cancer Center of Kansas, PA - Wichita
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Cancer Center of Kansas, PA - Medical Arts Tower
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	CCOP - Wichita
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Via Christi Cancer Center at Via Christi Regional Medical Center
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Winfield
	Cancer Center of Kansas, PA - Winfield
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
Louisiana
	Alexandria
	Tulane Cancer Center Office of Clinical Research
		Clinical Trials Office - Tulane Cancer Center	Ph:  504-988-6121
Maryland
	Baltimore
	Greenebaum Cancer Center at University of Maryland Medical Center
		Clinical Trials Office - Greenebaum Cancer Center at University of Maryladn Medical Center	Ph:  800-888-8823
	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
		Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Center at John Hopkins	Ph:  410-955-8804
			Email: jhcccro@jhmi.edu
	Elkton MD
	Union Hospital of Cecil County
		Gregory Masters, MD	Ph:  302-366-1200
Massachusetts
	Boston
	Boston University Cancer Research Center
		Clinical Trials Office - Boston University Cancer Research Center	Ph:  617-638-8265
Michigan
	Ann Arbor
	University of Michigan Comprehensive Cancer Center
		Clinical Trials Office - University of Michigan Comprehensive Cancer Center	Ph:  800-865-1125
	Kalamazoo
	Borgess Medical Center
		Raymond Lord, MD	Ph:  269-373-7458
	Bronson Methodist Hospital
		Raymond Lord, MD	Ph:  269-373-7458
	West Michigan Cancer Center
		Clinical Trials Office - West Michigan Cancer Center	Ph:  269-373-7458
Minnesota
	Burnsville
	Fairview Ridges Hospital
		Patrick Flynn, MD	Ph:  612-863-8585
	Coon Rapids
	Mercy and Unity Cancer Center at Mercy Hospital
		Patrick Flynn, MD	Ph:  612-863-8585
	Edina
	Fairview Southdale Hospital
		Clinical Trials Office - Fairview Southdale Hospital	Ph:  612-625-3650
	Fergus Falls
	Fergus Falls Medical Group, PA
		Preston Steen, MD	Ph:  701-234-2397
	Fridley
	Mercy and Unity Cancer Center at Unity Hospital
		Patrick Flynn, MD	Ph:  612-863-8585
	Hutchinson
	Hutchinson Area Health Care
		Patrick Flynn, MD	Ph:  612-863-8585
	Maplewood
	HealthEast Cancer Care at St. John's Hospital
		Patrick Flynn, MD	Ph:  612-863-8585
	Minnesota Oncology Hematology, PA - Maplewood
		Patrick Flynn, MD	Ph:  612-863-8585
	Minneapolis
	Hennepin County Medical Center - Minneapolis
		Clinical Trials Office - Hennepin County Medical Center - Minneapolis	Ph:  612-873-5911
	Masonic Cancer Center at University of Minnesota
		Clinical Trials Office - Masonic Cancer Center at University of Minnesota	Ph:  612-624-2620
	Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
		Clinical Trials Office - Virginia Piper Cancer Institute	Ph:  612-863-5654
	Robbinsdale
	Humphrey Cancer Center at North Memorial Outpatient Center
		Clinical Trials Office - Humphrey Cancer Center at North Memorial Outpatient Center	Ph:  763-520-1893
	Rochester
	Mayo Clinic Cancer Center
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
	Saint Louis Park
	CCOP - Metro-Minnesota
		Patrick Flynn, MD	Ph:  612-863-8585
	Park Nicollet Cancer Center
		Patrick Flynn, MD	Ph:  612-863-8585
	Saint Paul
	United Hospital
		Patrick Flynn, MD	Ph:  612-863-8585
	Shakopee
	St. Francis Cancer Center at St. Francis Medical Center
		Patrick Flynn, MD	Ph:  612-863-8585
	St. Paul
	Regions Hospital Cancer Care Center
		Clinical Trials Office - Regions Hospital Cancer Care Center	Ph:  651-254-1517
	Stillwater
	Lakeview Hospital
		Patrick Flynn, MD	Ph:  612-863-8585
	Waconia
	Ridgeview Medical Center
		Patrick Flynn, MD	Ph:  612-863-8585
	Willmar
	Willmar Cancer Center at Rice Memorial Hospital
		Patrick Flynn, MD	Ph:  612-863-8585
	Woodbury
	Minnesota Oncology Hematology, PA - Woodbury
		Patrick Flynn, MD	Ph:  612-863-8585
Mississippi
	Jackson
	University of Mississippi Cancer Clinic
		Stephanie Elkins	Ph:  601-984-5590
Missouri
	Columbia
	Ellis Fischel Cancer Center at University of Missouri - Columbia
		Clinical Trial Office - Ellis Fischel Cancer Center	Ph:  573-882-7440
	Kansas City
	CCOP - Kansas City
		Rakesh Gaur, MD	Ph:  816-823-0555
	Heartland Hematology Oncology Associates, Incorporated
		Rakesh Gaur, MD	Ph:  816-823-0555
	North Kansas City Hospital
		Rakesh Gaur, MD	Ph:  816-823-0555
	Research Medical Center
		Rakesh Gaur, MD	Ph:  816-823-0555
	Saint Luke's Cancer Institute at Saint Luke's Hospital
		Rakesh Gaur, MD	Ph:  816-823-0555
	St. Joseph Medical Center
		Rakesh Gaur, MD	Ph:  816-823-0555
	Truman Medical Center - Hospital Hill
		Rakesh Gaur, MD	Ph:  816-823-0555
	Lee's Summit
	Saint Luke's East - Lee's Summit
		Rakesh Gaur, MD	Ph:  816-823-0555
	Liberty
	Liberty Hospital
		Rakesh Gaur, MD	Ph:  816-823-0555
	Saint Joseph
	Heartland Regional Medical Center
		Rakesh Gaur, MD	Ph:  816-823-0555
	Saint Joseph Oncology, Incorporated
		Rakesh Gaur, MD	Ph:  816-823-0555
	Saint Louis
	Saint Louis University Cancer Center
		Clinical Trials Office - Saint Louis University Cancer Center	Ph:  314-977-4440
	Springfield
	CCOP - Cancer Research for the Ozarks
		Robert Carolla	Ph:  417-269-4520
	Hulston Cancer Center at Cox Medical Center South
		Robert Carolla	Ph:  417-269-5257
Montana
	Billings
	Billings Clinic - Downtown
		Clinical Trials Office - Billings Clinic - Downtown	Ph:  800-996-2663
			Email: research@billingsclinic.org
	CCOP - Montana Cancer Consortium
		Benjamin Marchello, MD	Ph:  406-238-6290
	Hematology-Oncology Centers of the Northern Rockies - Billings
		Benjamin Marchello, MD	Ph:  406-238-6290
	St. Vincent Healthcare Cancer Care Services
		Benjamin Marchello, MD	Ph:  406-238-6290
	Bozeman
	Bozeman Deaconess Cancer Center
		Benjamin Marchello, MD	Ph:  406-238-6290
	Great Falls
	Big Sky Oncology
		Clinical Trial Office - Big Sky Oncology	Ph:  406-731-8217
	Great Falls Clinic - Main Facility
		Benjamin Marchello, MD	Ph:  406-238-6290
	Sletten Cancer Institute at Benefis Healthcare
		Grant Harrer, MD, FACP, CCTI	Ph:  406-731-8100
	Helena
	St. Peter's Hospital
		Benjamin Marchello, MD	Ph:  406-238-6290
	Kalispell
	Glacier Oncology, PLLC
		Benjamin Marchello, MD	Ph:  406-238-6290
	Kalispell Regional Medical Center
		Benjamin Marchello, MD	Ph:  406-238-6290
	Missoula
	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
		Clinical Trials Office - Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Ph:  406-329-7029
	Montana Cancer Specialists at Montana Cancer Center
		Clinical Trials Office - Montana Cancer Specialists at Montana Cancer Center	Ph:  406-238-6962
New Jersey
	Morristown
	Carol G. Simon Cancer Center at Morristown Memorial Hospital
		Neil Morganstein	Ph:  973-971-6100 800-247-9580
	Summit
	Overlook Hospital
		Neil Morganstein	Ph:  908-522-2000
	Voorhees
	Cancer Institute of New Jersey at Cooper - Voorhees
		Clinical Trials Office - Cancer Institute of New Jersey at Cooper University Hospital - Voorhees	Ph:  856-325-6757
New Mexico
	Albuquerque
	Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital
		Edward Libby	Ph:  505-291-2462
	University of New Mexico Cancer Center
		Clinical Trials Office - University of New Mexico Cancer Center	Ph:  505-272-6972
	Las Cruces
	University of New Mexico Cancer Center - South
		Edward Libby	Ph:  505-521-1554
New York
	Bronx
	Albert Einstein Cancer Center at Albert Einstein College of Medicine
		Clinical Trials Office - Albert Einstein Cancer Center at Albert Einstein College of Medicine	Ph:  718-904-2730
			Email: aecc@aecom.yu.edu
	Buffalo
	Roswell Park Cancer Institute
		Clinical Trials Office - Roswell Park Cancer Institute	Ph:  877-275-7724
	East Syracuse
	CCOP - Hematology-Oncology Associates of Central New York
		Jeffrey Kirshner, MD	Ph:  315-472-7504
	Middletown
	Tucker Center for Cancer Care at Orange Regional Medical Center
		Clinical Trials Office - Tucker Center for Cancer Care at Orange Regional Medical Center	Ph:  845-342-7609
	New Hyde Park
	Long Island Jewish Medical Center
		Dilip Patel, MD	Ph:  718-470-8931
	New York
	NYU Cancer Institute at New York University Medical Center
		Bruce Raphael, MD	Ph:  212-731-5185
North Carolina
	Charlotte
	Blumenthal Cancer Center at Carolinas Medical Center
		Clinical Trials Office - Blumenthal Cancer Center at Carolinas Medical Center	Ph:  704-355-2884
	Goldsboro
	Wayne Memorial Hospital, Incorporated
		James Atkins, MD	Ph:  919-580-0000
	Greenville
	Leo W. Jenkins Cancer Center at ECU Medical School
		Clinical Trials Office - Leo W. Jenkins Cancer Center at ECU Medical School	Ph:  252-744-2391
	Kinston
	Kinston Medical Specialists
		Peter Watson, MD	Ph:  252-559-2200ext.201
North Dakota
	Fargo
	CCOP - MeritCare Hospital
		Preston Steen, MD	Ph:  701-234-2397
Ohio
	Akron
	McDowell Cancer Center at Akron General Medical Center
		Esther Rehmus, MD	Ph:  330-344-6505
	Summa Center for Cancer Care at Akron City Hospital
		Clinical Trials Office - Akron City Hospital	Ph:  330-375-6101
	Cincinnati
	Jewish Hospital Cancer Center
		E. Randolph Broun, MD	Ph:  513-686-5482
	Cleveland
	Case Comprehensive Cancer Center
		Clinical Trials Office - Case Comprehensive Cancer Center	Ph:  800-641-2422
	MetroHealth Cancer Care Center at MetroHealth Medical Center
		Bruce Averbook, MD, FACS	Ph:  216-778-4795
	Lima
	St. Rita's Medical Center
		Clinical Trials Office - St. Rita's Medical Center	Ph:  419-226-9617
Pennsylvania
	Allentown
	Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
		Eliot Friedman, MD	Ph:  610-402-0512
	Bryn Mawr
	Bryn Mawr Hospital
		Clinical Trials Office - Bryn Mawr Hospital	Ph:  610-645-2680
	Danville
	Geisinger Cancer Institute at Geisinger Health
		Clinical Trials Office - Geisinger Cancer Institute	Ph:  570-271-5251
	Hazleton
	Geisinger Hazleton Cancer Center
		Edward Gorak, II	Ph:  570-459-2901
	Hershey
	Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
		Clinical Trials Office - Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center	Ph:  717-531-3779
			Email: CTO@hmc.psu.edu
	Lewistown
	Lewistown Hospital
		David Claxton	Ph:  717-242-7143
	Paoli
	Cancer Center of Paoli Memorial Hospital
		Clinical Trials Office - Cancer Center of Paoli Memorial Hospital	Ph:  610-648-1637
	Philadelphia
	Fox Chase Cancer Center - Philadelphia
		Clinical Trials Office - Fox Chase Cancer Center - Philadelphia	Ph:  215-728-4790
	Scranton
	Hematology and Oncology Associates of Northeastern Pennsylvania
		Martin Hyzinski, MD	Ph:  570-558-3020
	State College
	Geisinger Medical Group - Scenery Park
		Edward Gorak, II	Ph:  814-231-4560
	Mount Nittany Medical Center
		David Claxton	Ph:  814-231-7000
	Wilkes-Barre
	Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
		Clinical Trials Office - Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center	Ph:  570-271-5251
	Wynnewood
	CCOP - Main Line Health
		Paul Gilman, MD	Ph:  610-645-2000
	Lankenau Cancer Center at Lankenau Hospital
		Paul Gilman, MD	Ph:  610-645-2000
	York
	York Cancer Center at Apple Hill Medical Center
		Amir Tabatabai, MD	Ph:  717-741-9229
South Carolina
	Anderson
	AnMed Cancer Center
		Clinical Trials Office - AnMed Cancer Center	Ph:  864-512-1000
	Spartanburg
	CCOP - Upstate Carolina
		Clinical Trials Office - CCOP - Upstate Carolina	Ph:  800-486-5941
	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
		Clinical Trials Office - Gibbs Regional Cancer Center	Ph:  800-486-5941
South Dakota
	Sioux Falls
	Medical X-Ray Center, PC
		Miroslaw Mazurczak	Ph:  605-336-0515 800-473-0271
	Sanford Cancer Center at Sanford USD Medical Center
		Clinical Trials Office - Sanford Cancer Center	Ph:  605-328-1367
Tennessee
	Jackson
	West Tennessee Cancer Center at Jackson-Madison County General Hospital
		Clinical Trials Office - West Tennessee Cancer Center	Ph:  731-425-6865
	Knoxville
	U.T. Medical Center Cancer Institute
		Clinical Trials Office - U.T. Medical Center Cancer Institute	Ph:  865-544-9773
Virginia
	Danville
	Danville Regional Medical Center
		Clinical Trials Office - Danville Regional Medical Center	Ph:  434-799-3753
Wisconsin
	Chippewa Falls
	Marshfield Clinic - Chippewa Center
		Bilal Naqvi	Ph:  715-726-4200 800-334-4535
	Eau Claire
	Center for Cancer Treatment & Prevention at Sacred Heart Hospital
		Bilal Naqvi	Ph:  715-839-3956 800-839-3956
	Marshfield Clinic Cancer Care at Regional Cancer Center
		Bilal Naqvi	Ph:  715-387-5426
	La Crosse
	Gundersen Lutheran Center for Cancer and Blood
		Clinical Trials Office - Gundersen Lutheran Cancer Center	Ph:  608-775-2385
			Email: cancerctr@gundluth.org
	Madison
	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
		Clinical Trials Office - University of Wisconsin Paul P. Carbone Comprehensive Cancer Center	Ph:  608-262-5223
	Marshfield
	Marshfield Clinic - Marshfield Center
		Clinical Trials Office - Marshfield Clinic - Marshfield Center	Ph:  800-782-1581 ext. 94457
	Saint Joseph's Hospital
		Bilal Naqvi	Ph:  715-387-1713
	Milwaukee
	Medical Consultants, Limited
		Jonathan Treisman, MD	Ph:  414-385-3086
	Rice Lake
	Marshfield Clinic - Indianhead Center
		Bilal Naqvi	Ph:  715-236-8100
	Stevens Point
	Marshfield Clinic at Saint Michael's Hospital
		Bilal Naqvi	Ph:  715-295-1900 800-782-8581
	Saint Michael's Hospital Cancer Center
		Bilal Naqvi	Ph:  715-346-5000 800-472-9449
	Wausau
	Marshfield Clinic - Wausau Center
		Bilal Naqvi	Ph:  715-847-3000 800-847-0016
	Weston
	Diagnostic and Treatment Center
		Bilal Naqvi	Ph:  715-393-3900
	Marshfield Clinic - Weston Center
		Bilal Naqvi	Ph:  715-393-1000 888-782-8581
	Wisconsin Rapids
	Marshfield Clinic - Wisconsin Rapids Center
		Bilal Naqvi	Ph:  715-424-8600
Wyoming
	Casper
	Rocky Mountain Oncology
		Benjamin Marchello, MD	Ph:  406-238-6290
	Sheridan
	Welch Cancer Center at Sheridan Memorial Hospital
		Benjamin Marchello, MD	Ph:  406-238-6290

Related Information

PDQ® clinical trial SWOG-9007

Registry Information
Official Title		A Randomized Phase II Trial of Azacitidine with or without the Histone Deacetylase Inhibitor Entinostat for the Treatment of Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia (dysplastic type), and Acute Myeloid Leukemia with Multilineage Dysplasia
Trial Start Date		2006-08-18
Trial Completion Date		2008-02-03 (estimated)
Registered in ClinicalTrials.gov		NCT00313586
Date Submitted to PDQ		2006-01-10
Information Last Verified		2011-04-18
NCI Grant/Contract Number		CA21115

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