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

Basic Trial Information

Trial Description

Summary

RATIONALE: Drugs used in chemotherapy, such as clofarabine, daunorubicin hydrochloride, cytarabine, and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which chemotherapy regimen is more effective in treating acute myeloid leukemia.

PURPOSE: This randomized phase III trial is studying clofarabine to see how well it works compared with daunorubicin hydrochloride and cytarabine when followed by decitabine or observation in treating older patients with newly diagnosed acute myeloid leukemia.

Further Study Information

OBJECTIVES:

Primary

• To compare the overall survival of older patients with newly diagnosed acute myeloid leukemia (AML) treated with clofarabine as induction therapy and consolidation therapy vs standard daunorubicin hydrochloride and cytarabine.

Secondary

• To evaluate complete remission (CR) rates, duration of remission, and toxicity/treatment-related mortality of patients treated with these regimens.

• To evaluate the feasibility of consolidation therapy with reduced-intensity conditioning and allogeneic hematopoietic stem cell transplantation from HLA-identical donors, in terms of the incidence of successful engraftment, acute and chronic graft-vs-host disease, and transplant-related mortality in select patients age 60-69 years who achieve a response to induction therapy.

• To determine the impact of reduced-intensity conditioning and allogeneic stem cell transplantation on overall survival of select patients.

• To compare the duration of remission and disease-free survival of patients in CR following completion of consolidation therapy who are subsequently randomized to receive decitabine as maintenance therapy vs observation.

• To perform expression and methylation profiling in patients treated with decitabine as maintenance therapy and to correlate their integrated epigenetic signatures with response to decitabine.

• To examine the epigenetic profiles of remission marrow in patients randomized to receive decitabine as maintenance therapy vs observation to determine whether epigenetic signatures of apparently morphologically normal bone marrow is predictive of relapse or response to decitabine.

• To explore the possible association of response to clofarabine with nucleoside transporters hENT1, hCNT3, and ABC-transporter P-glycoprotein.

• To assess the intensity of expression of CXCR4 on diagnostic leukemia cells and to correlate this parameter with other established prognostic factors.

• To assess the entire spectrum of somatic mutations and affected pathways at diagnosis of AML and elucidate the association between gene mutation and outcome.

Tertiary

• To compare health-related quality of life (QOL) (physical, functional, leukemia-specific well-being) and fatigue in patients treated with clofarabine vs standard induction therapy.

• To measure the change in health-related QOL that occurs over time.

• To comprehensively assess patient function at the time of study enrollment.

• To determine if components of a comprehensive geriatric assessment or QOL scale predict ability to complete treatment for AML.

• To describe the impact of transplantation on QOL in patients with AML over 60 years of age.

OUTLINE: This is a multicenter study. Patients are stratified according to age (60-69 years vs ≥ 70 years), , disease type (secondary vs de novo), therapy-related AML (yes vs no), and antecedent hematologic disorder (yes vs no).

• Induction therapy: Patients are randomized to 1 of 2 treatment arms.

• Arm I (standard therapy): Patients receive daunorubicin hydrochloride IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients with residual disease or those who do not achieve an aplastic bone marrow on day 12-14 (i.e., < 5% blasts and < 20% cellularity or markedly/moderately hypocellular) may receive a second course of induction therapy beginning no sooner than day 14.

• Arm II: Patients receive clofarabine IV over 1 hour on days 1-5. Patients with residual disease or those who do not achieve an aplastic bone marrow on day 12-14 (i.e., < 5% blasts and < 20% cellularity or markedly/moderately hypocellular) may receive a second course of induction therapy beginning no sooner than day 21 and no later than day 56.

Patients who achieve a complete remission (CR) or CR incomplete (CRi) after induction therapy proceed to consolidation therapy. Patients who are 60-69 years of age who achieve a "morphologic leukemia-free state" after induction therapy and who have an HLA-identical donor proceed to allogeneic stem cell transplantation. Patients undergoing second induction who do not achieve CR by day 56 of the start of re-induction are taken off protocol.

• Consolidation therapy: Beginning within 60 days after documentation of CR or CRi, patients receive consolidation therapy in the same arm they were randomized to for induction therapy.

• Arm I (standard therapy): Patients receive cytarabine IV over 1 hour once or twice daily on days 1-6. Treatment repeats every 4-6 weeks for 2 courses.

• Arm II: Patients receive clofarabine IV over 1 hour on days 1-5. Treatment repeats every 4-6 weeks for 2 courses.

Patients who remain in CR after completion of consolidation therapy proceed to maintenance therapy.

• Maintenance therapy: Beginning within 60 days after completion of consolidation therapy, patients receive maintenance therapy and are randomized to 1 of 2 arms.

• Arm I: Patients undergo observation monthly for 12 months.

• Arm II: Patients receive decitabine IV over 1 hour on days 1-3. Treatment repeats every 4 weeks for 12 months the absence of unacceptable toxicity.

• Allogeneic stem cell transplantation with reduced-intensity conditioning regimen: Patients begin reduced-intensity conditioning 30-90 days after the initiation of induction therapy.

• Conditioning regimen: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3, busulfan IV over 2 hours every 6 hours on days -4 and -3 (for a total of 8 doses), and anti-thymocyte globulin IV over 4-6 hours on days -4 to -2.

• Transplantation: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

Patients complete quality-of-life questionnaires periodically, including health-related quality of life, physical and functional well-being, and fatigue questionnaires.

Peripheral blood, bone marrow, and karyotype samples are collected periodically for cytogenetic analysis and other correlative laboratory studies.

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

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Newly diagnosed acute myeloid leukemia (AML)

• Considered candidates for intensive chemotherapy based on examination of peripheral blood or bone marrow aspirate specimens or touch preparations of the bone marrow biopsy obtained within the past 2 weeks

• Bone marrow aspirate is required for enrollment, however, if there is discordance between percentage of myeloblasts on the differential of the peripheral blood or aspirate, the peripheral blood criteria are sufficient for diagnosis

• Patients with secondary AML (defined as AML that has developed in a person with a history of antecedent blood count abnormalities, myelodysplastic syndromes [MDS], or a myeloproliferative disorder [excluding chronic myeloid leukemia], or a history of prior chemotherapy or radiotherapy for a disease other than AML) are eligible

• Patients with acute promyelocytic leukemia (APL) confirmed either by the presence of t(15;17)(q22;q21) or PML/RAR transcripts will be excluded

• No blastic transformation of chronic myelogenous leukemia

• No documented CNS involvement

• Concurrent registration on ECOG-E3903 (Ancillary Laboratory Protocol for the Collecting of Diagnostic Samples from Patients With Leukemia or Related Hematologic Disorders Being Considered for ECOG Treatment Clinical Trials) required (except for patients participating at CTSU institutions; these patients are exempt from this requirement)

• Cytogenetic analysis must be performed from diagnostic bone marrow (preferred) or if adequate number of circulating blasts (>10^9/L) from peripheral blood

• Diagnostic bone marrow and peripheral blood specimens must be submitted for immunophenotyping and selected molecular testing

• Peripheral blood stem cell donor meeting 1 of the following criteria:

• HLA-identical sibling (6/6)

• Low-resolution HLA typing (A,B,DR) allowed

• Matched unrelated donor (10/10)

• High-resolution class I and II typing (A,B,C,DRB1 and DQ) should be matched at all 10 loci

PATIENT CHARACTERISTICS:

• ECOG performance status (PS) 0-3 (ECOG PS 0-2 if ≥ 70 years of age)

• AST and ALT ≤ grade 1

• Total serum bilirubin ≤ 1.5 times upper limit of normal (ULN) (≤ grade 1)

• Serum creatinine ≤ 1 mg/dL (≤ grade 1)

• Cardiac ejection fraction ≥ 45% by MUGA or 2-D ECHO

• Fertile patients must use effective contraception

• No concurrent active malignancy requiring treatment (other than MDS)

• No active, uncontrolled infection

• No known HIV infection

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior chemotherapy for AML (except for hydroxyurea for increased blast count or leukapheresis for leukocytes)

• No prior treatment with azacitidine, decitabine, or low-dose cytarabine

Trial Contact Information

Trial Lead Organizations/Sponsors

Eastern Cooperative Oncology Group

James M. Foran

Principal Investigator

U.S.A.
Alabama
	Birmingham
	UAB Comprehensive Cancer Center
		Carla I. Falkson	Ph: 205-934-0309
Arizona
	Phoeniz
	Mayo Clinic Hospital
		James M Foran	Ph: 507-538-7623
	Scottsdale
	Mayo Clinic Scottsdale
		James M Foran	Ph: 507-538-7623
	Tucson
	Arizona Cancer Center at University Medical Center North
		Faiz Anwer	Ph: 520-626-9008
	Arizona Cancer Center at University of Arizona Health Sciences Center
		Faiz Anwer	Ph: 520-626-9008
Colorado
	Aurora
	Medical Center of Aurora - South Campus
		Eduardo R. Pajon	Ph: 888-785-6789
	Boulder
	Boulder Community Hospital
		Eduardo R. Pajon	Ph: 888-785-6789
	Colorado Springs
	Penrose Cancer Center at Penrose Hospital
		Eduardo R. Pajon	Ph: 888-785-6789
	Denver
	CCOP - Colorado Cancer Research Program
		Eduardo R. Pajon	Ph: 888-785-6789
	Porter Adventist Hospital
		Eduardo R. Pajon	Ph: 888-785-6789
	Presbyterian - St. Luke's Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
	Rose Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
	St. Anthony Central Hospital
		Eduardo R. Pajon	Ph: 888-785-6789
	St. Joseph Hospital
		Eduardo R. Pajon	Ph: 888-785-6789
	Englewood
	Swedish Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
	Greeley
	North Colorado Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
	Littleton
	Littleton Adventist Hospital
		Eduardo R. Pajon	Ph: 888-785-6789
	Lone Tree
	Sky Ridge Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
	Longmont
	Hope Cancer Care Center at Longmont United Hospital
		Eduardo R. Pajon	Ph: 888-785-6789
	Loveland
	McKee Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
	Parker
	Parker Adventist Hospital
		Eduardo R. Pajon	Ph: 888-785-6789
	Pueblo
	St. Mary - Corwin Regional Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
	Wheat Ridge
	Exempla Lutheran Medical Center
		Eduardo R. Pajon	Ph: 888-785-6789
Connecticut
	Hartford
	Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
		Christopher M Reynolds	Ph: 734-712-3456
	New Britain
	George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
		Brian J Byrne	Ph: 860-224-5660
Delaware
	Lewes
	Tunnell Cancer Center at Beebe Medical Center
		Frank Beardell	Ph: 302-733-6227
	Newark
	Helen F. Graham Cancer Center at Christiana Hospital
		Frank Beardell	Ph: 302-733-6227
Florida
	Gainesville
	University of Florida Shands Cancer Center
		Jack W Hsu	Ph: 352-273-8675
			Email: trials@cancer.ufl.edu
	Jacksonville
	Mayo Clinic - Jacksonville
		James M Foran	Ph: 507-538-7623
	Orlando
	Florida Hospital Cancer Institute at Florida Hospital Orlando
		Lee M. Zehngebot	Ph: 407-303-5623
Georgia
	Atlanta
	CCOP - Atlanta Regional
		Thomas E. Seay	Ph: 404-303-3355
	Northside Hospital Cancer Center
		Thomas E. Seay	Ph: 404-303-3355
	Piedmont Hospital
		Thomas E. Seay	Ph: 404-303-3355
	Saint Joseph's Hospital of Atlanta
		Thomas E. Seay	Ph: 404-303-3355
	Augusta
	Medical College of Georgia Cancer Center
		Anand P. Jillella	Ph: 706-721-1663
			Email: cancer@georgiahealth.edu
	Austell
	WellStar Cobb Hospital
		Thomas E. Seay	Ph: 404-303-3355
	Columbus
	John B. Amos Cancer Center
		Thomas E. Seay	Ph: 404-303-3355
	Decatur
	Charles B. Eberhart Cancer Center at DeKalb Medical Center
		Thomas E. Seay	Ph: 404-303-3355
	Fayetteville
	Piedmont Fayette Hospital
		Thomas E. Seay	Ph: 404-303-3355
	Lawrenceville
	Gwinnett Medical Center
		Thomas E. Seay	Ph: 404-303-3355
	Marietta
	Kennestone Cancer Center at Wellstar Kennestone Hospital
		Thomas E. Seay	Ph: 404-303-3355
	Riverdale
	Southern Regional Medical Center
		Thomas E. Seay	Ph: 404-303-3355
	Rome
	Harbin Clinic Cancer Center - Medical Oncology
		Thomas E. Seay	Ph: 404-303-3355
Hawaii
	Aiea
	Kapiolani Medical Center at Pali Momi
		Jeffrey L. Berenberg	Ph: 808-586-2979
		Jeffrey L. Berenberg	Ph: 808-586-2979
	Honolulu
	Cancer Research Center of Hawaii
		Jeffrey L. Berenberg	Ph: 808-586-2979
	Kapiolani Medical Center for Women and Children
		Jeffrey L. Berenberg	Ph: 808-586-2979
	Kuakini Medical Center
		Jeffrey L. Berenberg	Ph: 808-586-2979
	OnCare Hawaii, Incorporated - Kuakini
		Jeffrey L. Berenberg	Ph: 808-586-2979
		Jeffrey L. Berenberg	Ph: 808-586-2979
	OnCare Hawaii, Incorporated - Lusitana
		Jeffrey L. Berenberg	Ph: 808-586-2979
	Queen's Cancer Institute at Queen's Medical Center
		Jeffrey L. Berenberg	Ph: 808-586-2979
	Straub Clinic and Hospital, Incorporated
		Jeffrey L. Berenberg	Ph: 808-586-2979
	Kailua
	Castle Medical Center
		Jeffrey L. Berenberg	Ph: 808-586-2979
	Lihue
	Kauai Medical Clinic
		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
Illinois
	Bloomington
	Illinois CancerCare - Bloomington
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	St. Joseph Medical Center
		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
	Mount Sinai Hospital Medical Center
		Pam G. Khosla	Ph: 773-257-5960
			Email: suhi@sinai.org
	Robert H. Lurie Comprehensive Cancer Center at Northwestern University
		Jessica K Altman	Ph: 312-695-1301
			Email: cancer@northwestern.edu
	Decatur
	Decatur Memorial Hospital Cancer Care Institute
		James L. Wade	Ph: 217-876-4740
			Email: kcheek@dmhhs.org
	Eureka
	Eureka Community Hospital
		John W. Kugler	Ph: 800-793-2262
	Illinois CancerCare - Eureka
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Galesburg
	Galesburg Clinic, PC
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Havana
	Illinois CancerCare - Havana
		John W. Kugler	Ph: 800-793-2262
	Highland Park
	Hematology Oncology Associates of Illinois-Highland Park
		Jessica K Altman	Ph: 312-695-1301
			Email: cancer@northwestern.edu
	Hinsdale
	Hinsdale Hematology Oncology Associates
		Elyse Cheryl Schneiderman	Ph: 630-654-1790
			Email: info@hhoaltd.com
	Kankakee
	Provena St. Mary's Regional Cancer Center - Kankakee
		Jessica K Altman	Ph: 312-695-1301
			Email: cancer@northwestern.edu
	Kewanee
	Illinois CancerCare - Kewanee Clinic
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Libertyville
	North Shore Oncology and Hematology Associates, Limited - Libertyville
		Jessica K Altman	Ph: 312-695-1301
			Email: cancer@northwestern.edu
	Macomb
	Illinois CancerCare - Macomb
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	McDonough District Hospital
		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
	Monmouth
	Illinois CancerCare - Monmouth
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	OSF Holy Family Medical Center
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Mt. Vernon
	Good Samaritan Regional Health Center
		Bethany G. Sleckman	Ph: 913-948-5588
	Niles
	Cancer Care and Hematology Specialists of Chicagoland - Niles
		Jessica K Altman	Ph: 312-695-1301
			Email: cancer@northwestern.edu
	Normal
	BroMenn Regional Medical Center
		John W. Kugler	Ph: 800-793-2262
	Community Cancer Center
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Illinois CancerCare - Community Cancer Center
		John W. Kugler	Ph: 800-793-2262
	Ottawa
	Community Hospital of Ottawa
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Illinois CancerCare - Ottawa
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Pekin
	Cancer Treatment Center at Pekin Hospital
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Illinois CancerCare - Pekin
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Peoria
	CCOP - Illinois Oncology Research Association
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Illinois CancerCare - Peoria
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Methodist Medical Center of Illinois
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	OSF St. Francis Medical Center
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Proctor Hospital
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Peru
	Illinois CancerCare - Princeton
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Illinois Valley Community Hospital
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Princeton
	Illinois CancerCare - Princeton
		Nguyet A Le-Lindqwister	Ph: 800-793-2262
	Rockford
	Swedish-American Regional Cancer Center
		Harvey Eric Einhorn	Ph: 815-489-4413
	Skokie
	Hematology Oncology Associates - Skokie
		Jessica K Altman	Ph: 312-695-1301
			Email: cancer@northwestern.edu
	Spring Valley
	Illinois CancerCare - Spring Valley
		John W. Kugler	Ph: 800-793-2262
	Springfield
	Regional Cancer Center at Memorial Medical Center
		James L. Wade	Ph: 217-876-4740
			Email: kcheek@dmhhs.org
Indiana
	Beech Grove
	St. Francis Hospital and Health Centers - Beech Grove Campus
		Howard M. Gross	Ph: 765-983-3000
	Fort Wayne
	Fort Wayne Medical Oncology and Hematology
		Sreenivasa Rao Nattam	Ph: 260-484-8830
			Email: ledgar@fwmoh.com
	Indianapolis
	St. Francis Hospital Cancer Care Services
		Howard M. Gross	Ph: 765-983-3000
	Richmond
	Reid Hospital & Health Care Services
		Howard M. Gross	Ph: 317-783-8918
Iowa
	Ames
	McFarland Clinic, PC
		Joseph James Merchant	Ph: 515-239-2621
	Sioux City
	Mercy Medical Center - Sioux City
		Donald Bruce Wender	Ph: 712-252-0088
	Siouxland Hematology-Oncology Associates, LLP
		Donald Bruce Wender	Ph: 712-252-0088
	St. Luke's Regional Medical Center
		Donald Bruce Wender	Ph: 712-252-0088
Kentucky
	Lexington
	University of Kentucky Chandler Medical Center
		Dianna S Howard	Ph: 859-257-3379
	Louisville
	Louisville Oncology at Norton Cancer Institute - Louisville
		Don A Stevens	Ph: 502-629-2500
Louisiana
	Baton Rouge
	Ochsner Health Center - Bluebonnet
		Robert V. Emmons	Ph: 888-562-4763
	New Orleans
	New Orleans Cancer Institute at Memorial Medical Center
		Robert V. Emmons	Ph: 888-562-4763
	Ochsner Cancer Institute at Ochsner Clinic Foundation
		Robert V. Emmons	Ph: 888-562-4763
Maine
	Augusta
	Harold Alfond Center for Cancer Care
		Thomas Henry Openshaw	Ph: 207-973-4274
	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
	Bethesda
	National Naval Medical Center
		David C Van Echo	Ph: 301-319-2100
	Elkton MD
	Union Hospital of Cecil County
		Frank Beardell	Ph: 302-733-6227
Massachusetts
	Boston
	Tufts Medical Center Cancer Center
		Kellie A Sprague	Ph: 617-636-5000
			Email: ContactUsCancerCenter@TuftsMedicalCenter.org
	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
Michigan
	Ann Arbor
	CCOP - Michigan Cancer Research Consortium
		Christopher M Reynolds	Ph: 734-712-3456
	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
	Big Rapids
	Mecosta County Medical Center
		Gilbert D Padula	Ph: 616-685-5225
	Dearborn
	Oakwood Cancer Center at Oakwood Hospital and Medical Center
		Christopher M Reynolds	Ph: 734-712-3456
	Detroit
	Van Elslander Cancer Center at St. John Hospital and Medical Center
		Christopher M Reynolds	Ph: 734-712-3456
	Flint
	Genesys Hurley Cancer Institute
		Christopher M Reynolds	Ph: 734-712-3456
		Christopher M Reynolds	Ph: 734-712-3456
	Hurley Medical Center
		Christopher M Reynolds	Ph: 734-712-3456
	Grand Blanc
	Genesys Regional Medical Center
		Christopher M Reynolds	Ph: 734-712-3456
	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
	Jackson
	Gayle M. Jacob Cancer Center at Allegiance Health
		Christopher M Reynolds	Ph: 734-712-3456
	Kalamazoo
	Borgess Medical Center
		Raymond Sterling Lord	Ph: 269-373-7458
	Bronson Methodist Hospital
		Raymond Sterling Lord	Ph: 269-373-7458
	West Michigan Cancer Center
		Raymond Sterling Lord	Ph: 269-373-7458
	Lansing
	Sparrow Regional Cancer Center
		Christopher M Reynolds	Ph: 734-712-3456
	Livonia
	St. Mary Mercy Hospital
		Christopher M Reynolds	Ph: 734-712-3456
	Muskegon
	Mercy General Health Partners
		Gilbert D Padula	Ph: 616-685-5225
	Pontiac
	St. Joseph Mercy Oakland
		Christopher M Reynolds	Ph: 734-712-3456
	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
	Saginaw
	Seton Cancer Institute at Saint Mary's - Saginaw
		Christopher M Reynolds	Ph: 734-712-3456
	Southfield
	Providence Hospital - Southfield
		Howard R. Terebelo	Ph: 248-849-5337
			Email: jaswinder.grewal@stjohn.org
	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
	Duluth
	CCOP - Duluth
		Daniel Nikcevich	Ph: 888-203-7267
	Essentia Health - Duluth Clinic
		Daniel Nikcevich	Ph: 888-203-7267
	Miller - Dwan Medical Center
		Daniel Nikcevich	Ph: 888-203-7267
	Fergus Falls
	Lake Region Healthcare Corporation-Cancer Care
		Preston D. Steen	Ph: 701-234-6161
	Rochester
	Mayo Clinic Cancer Center
		James M Foran	Ph: 507-538-7623
Mississippi
	Jackson
	University of Mississippi Cancer Clinic
		Stephanie L Elkins	Ph: 601-815-6700
Missouri
	Cape Girardeau
	Saint Francis Medical Center
		Bethany G. Sleckman	Ph: 913-948-5588
	Saint Louis
	CCOP - St. Louis-Cape Girardeau
		Bethany G. Sleckman	Ph: 913-948-5588
	David C. Pratt Cancer Center at St. John's Mercy
		Bethany G. Sleckman	Ph: 913-948-5588
	Mercy Clinic St. Louis Cancer and Breast Institute
		Bethany G. Sleckman	Ph: 913-948-5588
	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
		Geoffrey L Uy	Ph: 800-600-3606
			Email: info@siteman.wustl.edu
Montana
	Billings
	Billings Clinic Cancer Center - 801 N 29th Street
		Benjamin Thomas Marchello	Ph: 800-648-6274
	CCOP - Montana Cancer Consortium
		Benjamin Thomas Marchello	Ph: 800-648-6274
	Hematology-Oncology Centers of the Northern Rockies - Billings
		Benjamin Thomas Marchello	Ph: 800-648-6274
	St. Vincent Healthcare Cancer Care Services
		Benjamin Thomas Marchello	Ph: 800-648-6274
	Bozeman
	Bozeman Deaconess Cancer Center
		Benjamin Thomas Marchello	Ph: 800-648-6274
		Benjamin Thomas Marchello	Ph: 800-648-6274
	Butte
	St. James Healthcare Cancer Care
		Benjamin Thomas Marchello	Ph: 800-648-6274
	Great Falls
	Benefis Sletten Cancer Institute
		Benjamin Thomas Marchello	Ph: 800-648-6274
	Helena
	St. Peter's Hospital
		Benjamin Thomas Marchello	Ph: 800-648-6274
	Kalispell
	Kalispell Regional Medical Center
		Benjamin Thomas Marchello	Ph: 800-648-6274
	Missoula
	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
		Benjamin Thomas Marchello	Ph: 800-648-6274
	Montana Cancer Specialists at Montana Cancer Center
		Benjamin Thomas Marchello	Ph: 800-648-6274
Nevada
	Las Vegas
	CCOP - Nevada Cancer Research Foundation
		John Allan Ellerton	Ph: 702-731-8274
New Jersey
	Camden
	Cancer Institute of New Jersey at Cooper University Hospital - Camden
		Frank Beardell	Ph: 302-733-6227
New York
	Mineola
	Winthrop University Hospital
		Harry Staszewski	Ph: 866-946-8476
	New York
	Memorial Sloan-Kettering Cancer Center
		Martin Stuart Tallman	Ph: 212-639-7202
			Email: cancer@northwestern.edu
	Rochester
	James P. Wilmot Cancer Center at University of Rochester Medical Center
		Jonathan W Friedberg	Ph: 585-275-5830
North Carolina
	Hendersonville
	Park Ridge Hospital Breast Health Center
		Charles E Bowers	Ph: 800-486-5941
	Kinston
	Kinston Medical Specialists
		Peter R. Watson	Ph: 252-559-2200
North Dakota
	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
	Akron
	McDowell Cancer Center at Akron General Medical Center
		Esther H. Rehmus	Ph: 330-344-6348
	Summa Center for Cancer Care at Akron City Hospital
		Jennifer E Payne	Ph: 330-375-6101
	Barberton
	Barberton Citizens Hospital
		Jennifer E Payne	Ph: 330-375-6101
	Canton
	Aultman Cancer Center at Aultman Hospital
		Kisa E Weeman	Ph: 330-363-6891
	Cincinnati
	Jewish Hospital Cancer Center
		E. Randolph Broun	Ph: 513-686-5482
	Cleveland
	Case Comprehensive Cancer Center
		Hillard M. Lazarus	Ph: 800-641-2422
	MetroHealth Cancer Care Center at MetroHealth Medical Center
		Bruce J. Averbook	Ph: 216-778-8526
			Email: kbauchens@metrohealth.org
	Dayton
	CCOP - Dayton
		Howard M. Gross	Ph: 317-783-8918
	David L. Rike Cancer Center at Miami Valley Hospital
		Howard M. Gross	Ph: 317-783-8918
	Good Samaritan Hospital
		Howard M. Gross	Ph: 317-783-8918
	Grandview Hospital
		Howard M. Gross	Ph: 317-783-8918
	Samaritan North Cancer Care Center
		Howard M. Gross	Ph: 317-783-8918
	Findlay
	Blanchard Valley Regional Cancer Center
		Howard M. Gross	Ph: 317-783-8918
	Franklin
	Atrium Medical Center
		Howard M. Gross	Ph: 765-983-3000
	Greenville
	Wayne Hospital
		Howard M. Gross	Ph: 317-783-8918
	Kettering
	Charles F. Kettering Memorial Hospital
		Howard M. Gross	Ph: 317-783-8918
	Lima
	St. Rita's Medical Center
		Henry Gerad	Ph: 419-226-9617
	Troy
	UVMC Cancer Care Center at Upper Valley Medical Center
		Howard M. Gross	Ph: 765-983-3000
	Xenia
	Ruth G. McMillan Cancer Center at Greene Memorial Hospital
		Howard M. Gross	Ph: 317-783-8918
Oklahoma
	Oklahoma City
	Oklahoma University Cancer Institute
		Carla Kurkjian	Ph: 405-271-4272
			Email: julie-traylor@ouhsc.edu
Oregon
	Clackamas
	Clackamas Radiation Oncology Center
		Alison K Conlin	Ph: 503-215-6412
	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
	CCOP - Columbia River Oncology Program
		Alison K Conlin	Ph: 503-215-6412
	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
	Danville
	Geisinger Cancer Institute at Geisinger Health
		Edward J Gorak	Ph: 570-271-5251
	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
	Lewistown
	Lewistown Hospital
		David F Claxton	Ph: 717-531-3779
			Email: CTO@hmc.psu.edu
	Philadelphia
	Abramson Cancer Center of the University of Pennsylvania
		Selina M. Luger	Ph: 800-474-9892
	Scranton
	Hematology and Oncology Associates of North East Pennsylvania
		Andrew E Chapman	Ph: 215-955-6084
	State College
	Geisinger Medical Group - Scenery Park
		Edward J Gorak	Ph: 570-271-5251
	Mount Nittany Medical Center
		David F Claxton	Ph: 717-531-3779
			Email: CTO@hmc.psu.edu
	Wilkes-Barre
	Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
		Edward J Gorak	Ph: 570-271-5251
	York
	WellSpan Health
		Amir Tabatabai	Ph: 877-441-7957
South Carolina
	Anderson
	AnMed Cancer Center
		Charles E Bowers	Ph: 800-486-5941
	Greenville
	Bon Secours St. Francis Health System
		Charles E Bowers	Ph: 800-486-5941
	Lancaster
	Carolina Blood and Cancer Care Associates, PA
		Charles E Bowers	Ph: 800-486-5941
	Rock Hill
	Carolina Blood and Cancer Care
		Charles E Bowers	Ph: 800-486-5941
	Spartanburg
	CCOP - Upstate Carolina
		Charles E Bowers	Ph: 800-486-5941
	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
		Charles E Bowers	Ph: 800-486-5941
South Dakota
	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
	Chattanooga
	Erlanger Cancer Center at Erlanger Hospital - Baroness
		Larry L. Schlabach	Ph: 423-778-6947
	Jackson
	West Tennessee Cancer Center at Jackson-Madison County General Hospital
		Brion V Randolph	Ph: 731-425-6865
	Nashville
	Vanderbilt-Ingram Cancer Center
		Stephen A Strickland	Ph: 800-811-8480
Washington
	Vancouver
	Northwest Cancer Specialists at Vancouver Cancer Center
		Alison K Conlin	Ph: 503-215-6412
	Southwest Washington Medical Center Cancer Center
		Alison K Conlin	Ph: 503-215-6412
West Virginia
	Charleston
	West Virginia University Medical School - Charleston
		Steven J. Jubelirer	Ph: 304-388-9944
	Morgantown
	Mary Babb Randolph Cancer Center at West Virginia University Hospitals
		Michael D Craig	Ph: 304-293-2745
			Email: sfilburn@hsc.wvu.edu
Wisconsin
	Green Bay
	Green Bay Oncology, Limited at St. Mary's Hospital
		Gerald K. Bayer	Ph: 800-432-6049
	Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
		Gerald K. Bayer	Ph: 800-432-6049
	St. Mary's Hospital Medical Center - Green Bay
		Gerald K. Bayer	Ph: 800-432-6049
	St. Vincent Hospital Regional Cancer Center
		Gerald K. Bayer	Ph: 800-432-6049
	La Crosse
	Gundersen Lutheran Center for Cancer and Blood
		Kurt Oettel	Ph: 608-775-2385
			Email: cancerctr@gundluth.org
	Madison
	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
		Ryan J Mattison	Ph: 877-405-6866
	Manitowoc
	Holy Family Memorial Medical Center Cancer Care Center
		Gerald K. Bayer	Ph: 800-432-6049
	Marinette
	Bay Area Cancer Care Center at Bay Area Medical Center
		Gerald K. Bayer	Ph: 800-432-6049
	Milwaukee
	Froedtert Hospital and Medical College of Wisconsin
		Ehab L Atallah	Ph: 414-805-4380
	Mukwonago
	D.N. Greenwald Center
		Michael A Thompson	Ph: 262-928-7632
	Oconomowoc
	Regional Cancer Center at Oconomowoc Memorial Hospital
		Michael A Thompson	Ph: 262-928-7632
	Sheboygan
	Saint Nicholas Hospital
		Gerald K. Bayer	Ph: 800-432-6049
	Waukesha
	Waukesha Memorial Hospital Regional Cancer Center
		Michael A Thompson	Ph: 262-928-7632
	Wauwatosa
	Oncology Alliance, SC - Milwaukee - West
		Rubina Qamar	Ph: 888-709-2080
Wyoming
	Casper
	Rocky Mountain Oncology
		Benjamin Thomas Marchello	Ph: 800-648-6274
	Sheridan
	Welch Cancer Center at Sheridan Memorial Hospital
		Benjamin Thomas Marchello	Ph: 800-648-6274
Israel
	Haifa
	Rambam Medical Center
		Jacob M. Rowe	Ph: 972-4-8541737
			Email: y_rozen@rambam.health.gov.il
	Jerusalem
	Shaare Zedek Medical Center
		Jacob M. Rowe	Ph: 972-4-8541737
			Email: y_rozen@rambam.health.gov.il

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01041703
Information obtained from ClinicalTrials.gov on December 05, 2012

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