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Clinical Trials (PDQ®)

Clofarabine or Daunorubicin Hydrochloride and Cytarabine Followed By Decitabine or Observation in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIBiomarker/Laboratory analysis, TreatmentActive60 and overNCI, OtherCDR0000659585
ECOG-E2906, E2906, NCT01041703

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

National Cancer Institute

James M. ForanPrincipal Investigator

Trial Sites

U.S.A.
Alabama
  Birmingham
 UAB Comprehensive Cancer Center
 Carla I. Falkson Ph: 205-934-0309
Alaska
  Anchorage
 Alaska Breast Care and Surgery LLC
 Alison K Conlin Ph: 503-215-6412
 Alaska Women's Cancer Care
 Alison K Conlin Ph: 503-215-6412
 Anchorage Oncology Centre
 Alison K Conlin Ph: 503-215-6412
 Katmai Oncology Group
 Alison K Conlin Ph: 503-215-6412
 Providence Cancer Center
 Alison K Conlin Ph: 503-215-6412
Arizona
  Phoenix
 Mayo Clinic Methodist 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
California
  Orange
 Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
 Deepa Jeyakumar Ph: 877-827-8839
  Email: ucstudy@uci.edu
Colorado
  Aurora
 Medical Center of Aurora - South Campus
 Keren Sturtz Ph: 888-785-6789
  Boulder
 Boulder Community Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers-Boulder
 Keren Sturtz Ph: 888-785-6789
  Colorado Springs
 Penrose Cancer Center at Penrose Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers at the Pavilion
 Keren Sturtz Ph: 888-785-6789
  Denver
 CCOP - Colorado Cancer Research Program
 Keren Sturtz Ph: 888-785-6789
 Colorado Blood Cancer Institute
 Keren Sturtz Ph: 888-785-6789
 Porter Adventist Hospital
 Keren Sturtz Ph: 888-785-6789
 Presbyterian - St. Luke's Medical Center
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers - Denver Midtown
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers-Rose
 Keren Sturtz Ph: 888-785-6789
 Rose Medical Center
 Keren Sturtz Ph: 888-785-6789
 St. Joseph Hospital
 Keren Sturtz Ph: 888-785-6789
  Durango
 Mercy Medical Center
 Cynthia K. Cathcart Ph: 888-785-6789
  Englewood
 Comprehensive Cancer Care and Research Institute of Colorado LLC
 Keren Sturtz Ph: 888-785-6789
 Swedish Medical Center
 Keren Sturtz Ph: 888-785-6789
  Golden
 Mountain Blue Cancer Care Center
 Keren Sturtz Ph: 888-785-6789
  Greeley
 North Colorado Medical Center
 Keren Sturtz Ph: 888-785-6789
  Greenwood Village
 Breast Cancer Care Consultants
 Keren Sturtz Ph: 888-785-6789
  Lakewood
 Rocky Mountain Cancer Centers-Lakewood
 Keren Sturtz Ph: 888-785-6789
 St. Anthony Central Hospital
 Keren Sturtz Ph: 888-785-6789
  Littleton
 Littleton Adventist Hospital
 Keren Sturtz Ph: 888-785-6789
  Lone Tree
 Rocky Mountain Cancer Centers - Lone Tree
 Keren Sturtz Ph: 888-785-6789
 Sky Ridge Medical Center
 Keren Sturtz Ph: 888-785-6789
  Longmont
 Hope Cancer Care Center at Longmont United Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers - Longmont
 Keren Sturtz Ph: 888-785-6789
  Loveland
 McKee Medical Center
 Keren Sturtz Ph: 888-785-6789
  Parker
 Parker Adventist Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers - Parker
 Keren Sturtz Ph: 888-785-6789
  Pueblo
 Rocky Mountain Cancer Centers - Pueblo
 Keren Sturtz Ph: 888-785-6789
 St. Mary - Corwin Regional Medical Center
 Keren Sturtz Ph: 888-785-6789
  Wheat Ridge
 Exempla Lutheran Medical Center
 Keren Sturtz Ph: 888-785-6789
Connecticut
  Hartford
 Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
 Christopher M Reynolds Ph: 734-712-4673
  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
 Christiana Gynecologic Oncology, LLC
 Frank Beardell Ph: 302-733-6227
 Delaware Clinical and Laboratory Physicians
 Frank Beardell Ph: 302-733-6227
 Helen F. Graham Cancer Center at Christiana Hospital
 Frank Beardell Ph: 302-733-6227
 Frank Beardell Ph: 302-733-6227
 Medical Oncology Hematology Consultants, PA at Helen F. Graham Cancer Center
 Frank Beardell Ph: 302-733-6227
 Regional Hematology/Oncology, PA - Newark
 Frank Beardell Ph: 302-733-6227
  Rehoboth Beach
 Beebe Health Campus
 Frank Beardell Ph: 302-733-6227
  Seaford
 Nanticoke Memorial Hospital
 Frank Beardell Ph: 302-733-6227
  Wilmington
 Christiana Care Health System-Wilmington Hospital
 Frank Beardell Ph: 302-733-6227
Florida
  Gainesville
 UF Health 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
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
  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
Idaho
  Boise
 Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
 Christopher M Reynolds Ph: 734-712-4673
  Coeur D'Alene
 Kootenai Medical Center
 Benjamin Thomas Marchello Ph: 800-648-6274
  Post Falls
 Kootenai Cancer Center - Post Falls
 Benjamin Thomas Marchello Ph: 800-648-6274
  Sandpoint
 Kootenai Cancer
 Benjamin Thomas Marchello Ph: 800-648-6274
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
  Carbondale
 Memorial Hospital of Carbondale
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Carthage
 Illinois CancerCare - Carthage
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Centralia
 Centralia Oncology Clinic
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Chicago
 Robert H. Lurie Comprehensive Cancer Center at Northwestern University
 Jessica K Altman Ph: 312-695-1301
  Email: cancer@northwestern.edu
 University of Illinois Cancer Center
 John G Quigley Ph: 312-355-3046
  Decatur
 Cancer Care Center of Decatur
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
 Decatur Memorial Hospital Cancer Care Institute
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Effingham
 Crossroads Cancer Center
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Eureka
 Illinois CancerCare - Eureka
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Galesburg
 Galesburg Clinic, PC
 Nguyet A Le-Lindqwister 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
 Kathleen W Phelan 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
  Mount Vernon
 Good Samaritan Regional Health Center
 Jay W Carlson Ph: 800-821-7532
  Niles
 Cancer Care and Hematology Specialists of Chicagoland - Niles
 Jessica K Altman Ph: 312-695-1301
  Email: cancer@northwestern.edu
  Normal
 Community Cancer Center
 Nguyet A Le-Lindqwister 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
 Advanced Care and Treatment Medical Group, PC
 Harvey Eric Einhorn Ph: 779-696-9400
  Email: cancercare@swedishamerican.org
  Skokie
 Hematology Oncology Associates - Skokie
 Jessica K Altman Ph: 312-695-1301
  Email: cancer@northwestern.edu
  Springfield
 Regional Cancer Center at Memorial Medical Center
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
Indiana
  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
 Stephen E Rubenstein Ph: 317-851-2555
Iowa
  Ames
 McFarland Clinic, PC
 Joseph James Merchant Ph: 515-239-2621
 William R. Bliss Cancer Center at Mary Greeley Medical Center
 Joseph James Merchant Ph: 515-239-2621
  Boone
 McFarland Clinic PC-Boone
 Joseph James Merchant Ph: 515-239-2621
  Fort Dodge
 Trinity Regional Medical Center
 Joseph James Merchant Ph: 515-239-2621
  Jefferson
 McFarland Clinic PC-Jefferson
 Joseph James Merchant Ph: 515-239-2621
  Marshalltown
 McFarland Clinic PC-Marshalltown
 Joseph James Merchant Ph: 515-239-2621
  Sioux City
 Siouxland Hematology-Oncology Associates, LLP
 Donald Bruce Wender Ph: 712-252-0088
Kentucky
  Lexington
 University of Kentucky Chandler Medical Center
 Zartash Gul 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: 203-785-5702
  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
 Beth Israel Deaconess Medical Center
 David Avigan Ph: 617-667-9925
 Boston University Cancer Research Center
 John M Sloan Ph: 617-638-8265
 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
 Saint Joseph Mercy Cancer Center
 Christopher M Reynolds Ph: 734-712-4673
  Battle Creek
 Battle Creek Health System Cancer Care Center
 Gilbert D Padula Ph: 616-685-5225
  Dearborn
 Oakwood Cancer Center at Oakwood Hospital and Medical Center
 Christopher M Reynolds Ph: 734-712-4673
  Detroit
 Van Elslander Cancer Center at St. John Hospital and Medical Center
 Christopher M Reynolds Ph: 734-712-4673
  Flint
 Genesys Hurley Cancer Institute
 Christopher M Reynolds Ph: 734-712-4673
 Hurley Medical Center
 Christopher M Reynolds Ph: 734-712-4673
  Grand Rapids
 Butterworth Hospital at Spectrum Health
 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: 734-712-4673
  Kalamazoo
 West Michigan Cancer Center
 Sunil Nagpal Ph: 269-373-7458
  Lansing
 Sparrow Regional Cancer Center
 Christopher M Reynolds Ph: 734-712-4673
  Livonia
 St. Mary Mercy Hospital
 Christopher M Reynolds Ph: 734-712-4673
  Muskegon
 Mercy General Health Partners
 Gilbert D Padula Ph: 616-685-5225
  Pontiac
 St. Joseph Mercy Oakland
 Christopher M Reynolds Ph: 734-712-4673
  Port Huron
 Mercy Regional Cancer Center at Mercy Hospital
 Christopher M Reynolds Ph: 734-712-4673
  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: 734-712-4673
  Traverse City
 Munson Medical Center
 Gilbert D Padula Ph: 616-685-5225
  Warren
 St. John Macomb Hospital
 Christopher M Reynolds Ph: 734-712-4673
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
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Saint Louis
 CCOP - St. Louis-Cape Girardeau
 Bethany G. Sleckman Ph: 913-948-5588
 David C. Pratt Cancer Center at St. John's Mercy
 Jay W Carlson Ph: 800-821-7532
 Mercy Clinic St. Louis Cancer and Breast Institute
 Jay W Carlson Ph: 800-821-7532
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 Geoffrey L Uy Ph: 800-600-3606
  Email: info@siteman.wustl.edu
  Springfield
 Hulston Cancer Center at Cox Medical Center South
 Jay W Carlson Ph: 800-821-7532
 St. John's Regional Health Center
 Jay W Carlson Ph: 800-821-7532
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
 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
  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
 Community Medical Center
 Benjamin Thomas Marchello Ph: 800-648-6274
 Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
 Benjamin Thomas Marchello Ph: 800-648-6274
Nevada
  Henderson
 21st Century Oncology - Henderson
 John Allan Ellerton Ph: 702-384-0013
 Cancer and Blood Specialists-Henderson
 John Allan Ellerton Ph: 702-384-0013
 Comprehensive Cancer Centers of Nevada - Henderson
 John Allan Ellerton Ph: 702-384-0013
 Comprehensive Cancer Centers of Nevada-Southeast Henderson
 John Allan Ellerton Ph: 702-384-0013
 Las Vegas Cancer Center - Henderson
 John Allan Ellerton Ph: 702-384-0013
  Las Vegas
 21st Century Oncology - Fort Apache
 John Allan Ellerton Ph: 702-384-0013
 21st Century Oncology - Vegas Sunrise
 John Allan Ellerton Ph: 702-384-0013
 21st Century Oncology - Vegas Tenaya
 John Allan Ellerton Ph: 702-384-0013
 Cancer and Blood Specialists-Fort Apache
 John Allan Ellerton Ph: 702-384-0013
 Cancer and Blood Specialists-Shadow
 John Allan Ellerton Ph: 702-384-0013
 Cancer and Blood Specialists-Tenaya
 John Allan Ellerton Ph: 702-384-0013
 Cancer Institute of Nevada at Summerlin Hospital Medical Center
 John Allan Ellerton Ph: 702-384-0013
 John Allan Ellerton Ph: 702-384-0013
 Cancer Therapy and Integrative Medicine
 John Allan Ellerton Ph: 702-384-0013
 CCOP - Nevada Cancer Research Foundation
 John Allan Ellerton Ph: 702-384-0013
 Comprehensive Cancer Centers of Nevada - Central Valley
 John Allan Ellerton Ph: 702-384-0013
 Comprehensive Cancer Centers of Nevada - Northwest
 John Allan Ellerton Ph: 702-384-0013
 Comprehensive Cancer Centers of Nevada - Southwest
 John Allan Ellerton Ph: 702-384-0013
 HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
 John Allan Ellerton Ph: 702-384-0013
 HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
 John Allan Ellerton Ph: 702-384-0013
 HealthCare Partners Medical Group Oncology/Hematology-San Martin
 John Allan Ellerton Ph: 702-384-0013
 HealthCare Partners Medical Group Oncology/Hematology-Tenaya
 John Allan Ellerton Ph: 702-384-0013
 Las Vegas Cancer Center-Medical Center
 John Allan Ellerton Ph: 702-384-0013
 Radiation Oncology Centers of Las Vegas - Downtown Location
 John Allan Ellerton Ph: 702-384-0013
 Radiation Oncology Centers of Las Vegas - Eastern Location
 John Allan Ellerton Ph: 702-384-0013
  Reno
 Saint Mary's Regional Medical Center
 Cecilia Y Arana Yi Ph: 505-272-6972
New Jersey
  Camden
 Cancer Institute of New Jersey at Cooper University Hospital - Camden
 Frank Beardell Ph: 302-733-6227
  New Brunswick
 Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
 Dale G. Schaar Ph: 732-235-8675
New Mexico
  Albuquerque
 University of New Mexico Cancer Center
 Cecilia Y Arana Yi Ph: 505-272-6972
New York
  Manhasset
 Don Monti Comprehensive Cancer Center at North Shore University Hospital
 Jonathan Eliahu Kolitz Ph: 516-562-3467
  New Hyde Park
 Long Island Jewish Medical Center
 Jonathan Eliahu Kolitz Ph: 516-562-3467
 Monter Cancer Center of the North Shore-LIJ Health System
 Jonathan Eliahu Kolitz Ph: 516-562-3467
  New York
 Memorial Sloan-Kettering Cancer Center
 Martin Stuart Tallman Ph: 212-639-7202
  Rochester
 James P. Wilmot Cancer Center at University of Rochester Medical Center
 Jonathan W Friedberg Ph: 585-275-5830
  Syracuse
 SUNY Upstate Medical University Hospital
 Teresa C. Gentile Ph: 315-464-5476
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
  Winston-Salem
 Wake Forest University Comprehensive Cancer Center
 Bayard L. Powell Ph: 336-713-6771
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
  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
 University of Cincinnati
 Stephen C Medlin Ph: 513-558-4553
  Email: uchealthnews@uc.edu
  Cleveland
 Case Comprehensive Cancer Center
 Hillard M. Lazarus Ph: 800-641-2422
  Lima
 St. Rita's Medical Center
 Henry Gerad Ph: 419-226-9617
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 Mohamad Cherry Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
Oregon
  Clackamas
 Clackamas Radiation Oncology Center
 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
 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
  Bethlehem
 Lehigh Valley Hospital - Muhlenberg
 Eliot Lawrence Friedman Ph: 610-402-2273
  Danville
 Geisinger Cancer Institute at Geisinger Health
 Edward J Gorak Ph: 570-271-5251
  Ephrata
 Ephrata Cancer Center at Ephrata Community Hospital
 Amir Tabatabai Ph: 877-441-7957
 Amir Tabatabai Ph: 877-441-7957
  Gettysburg
 Adams Cancer Center
 Amir Tabatabai Ph: 877-441-7957
  Hanover
 Cherry Tree Cancer Center
 Amir Tabatabai Ph: 877-441-7957
  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
 Edward J Gorak Ph: 570-271-5251
  Philadelphia
 Abramson Cancer Center of the University of Pennsylvania
 Selina M. Luger Ph: 800-474-9892
  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
 York Cancer Center at Apple Hill Medical Center
 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
  Greer
 Gibbs Cancer Center-Pelham
 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
 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
 Preston D. Steen Ph: 701-234-6161
 Preston D. Steen Ph: 701-234-6161
Tennessee
  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
  Longview
 Lower Columbia Regional Cancer Center at PeaceHealth-St. John Medical Center
 Alison K Conlin Ph: 503-215-6412
  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: 304-344-3457
  Morgantown
 Mary Babb Randolph Cancer Center at West Virginia University Hospitals
 Michael D Craig Ph: 304-293-2745
  Email: sfilburn@hsc.wvu.edu
Wisconsin
  Burlington
 Aurora Cancer Care-Burlington
 Rubina Qamar Ph: 888-709-2080
  Eau Claire
 Center for Cancer Treatment & Prevention at Sacred Heart Hospital
 Ali W. Bseiso Ph: 715-389-4457
 Marshfield Clinic Cancer Care at Regional Cancer Center
 Ali W. Bseiso Ph: 715-389-4457
  Elkhorn
 Vince Lombardi Cancer Center at Aurora Lakeland Medical Center - Elkhorn
 Rubina Qamar Ph: 888-709-2080
  Grafton
 Aurora Cancer Care-Grafton
 Rubina Qamar Ph: 888-709-2080
  Green Bay
 Green Bay Oncology, Limited at St. Mary's Hospital
 Brian L Burnette Ph: 800-432-6049
 Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
 Brian L Burnette Ph: 800-432-6049
 St. Mary's Hospital Medical Center - Green Bay
 Brian L Burnette Ph: 800-432-6049
 St. Vincent Hospital Regional Cancer Center
 Brian L Burnette Ph: 800-432-6049
 Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
 Rubina Qamar Ph: 888-709-2080
  Kenosha
 Oncology Alliance - Kenosha South
 Rubina Qamar Ph: 888-709-2080
  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
 Brian L Burnette Ph: 800-432-6049
  Marinette
 Bay Area Cancer Care Center at Bay Area Medical Center
 Brian L Burnette Ph: 800-432-6049
 Vince Lombardi Cancer Clinic - Marinette
 Rubina Qamar Ph: 888-709-2080
  Marshfield
 Marshfield Clinic - Marshfield Center
 Ali W. Bseiso Ph: 715-389-4457
 Saint Joseph's Hospital
 Ali W. Bseiso Ph: 715-389-4457
  Menomonee Falls
 Aurora Advanced Healthcare Inc-Menomonee Falls
 Rubina Qamar Ph: 888-709-2080
  Milwaukee
 Aurora Cancer Care-Milwaukee
 Rubina Qamar Ph: 888-709-2080
 Aurora Sinai Medical Center
 Rubina Qamar Ph: 888-709-2080
 Froedtert Hospital and Medical College of Wisconsin
 Ehab L Atallah Ph: 414-805-4380
 Oncology Alliance, SC - Milwaukee - South
 Rubina Qamar Ph: 888-709-2080
 Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
 Rubina Qamar Ph: 888-709-2080
  Minocqua
 Marshfield Clinic - Lakeland Center
 Ali W. Bseiso Ph: 715-389-4457
  Mukwonago
 D.N. Greenwald Center
 Timothy R Wassenaar Ph: 262-928-7878
  Oconomowoc
 Regional Cancer Center at Oconomowoc Memorial Hospital
 Timothy R Wassenaar Ph: 262-928-7878
  Oshkosh
 Vince Lombardi Cancer Clinic - Oshkosh
 Rubina Qamar Ph: 888-709-2080
  Racine
 Aurora Health Center - Racine
 Rubina Qamar Ph: 888-709-2080
  Rice Lake
 Marshfield Clinic - Indianhead Center
 Ali W. Bseiso Ph: 715-389-4457
 Ali W. Bseiso Ph: 715-389-4457
  Sheboygan
 Saint Nicholas Hospital
 Brian L Burnette Ph: 800-432-6049
 Vince Lombardi Cancer Clinic - Sheboygan
 Rubina Qamar Ph: 888-709-2080
  Stevens Point
 Marshfield Clinic at Saint Michael's Hospital
 Ali W. Bseiso Ph: 715-389-4457
  Summit
 Aurora Medical Center
 Rubina Qamar Ph: 888-709-2080
  Two Rivers
 Vince Lombardi Cancer Clinic - Two Rivers
 Rubina Qamar Ph: 888-709-2080
  Waukesha
 Aurora Cancer Care-Waukesha
 Rubina Qamar Ph: 888-709-2080
 Waukesha Memorial Hospital Regional Cancer Center
 Timothy R Wassenaar Ph: 262-928-7878
  Wauwatosa
 Oncology Alliance, SC - Milwaukee - West
 Rubina Qamar Ph: 888-709-2080
  West Allis
 Aurora Women's Pavilion of West Allis Memorial Hospital
 Rubina Qamar Ph: 888-709-2080
  Weston
 Marshfield Clinic - Weston Center
 Ali W. Bseiso Ph: 715-389-4457
 Ministry Saint Clare's Hospital
 Ali W. Bseiso Ph: 715-389-4457
Wyoming
  Cody
 Big Horn Basin Cancer Center
 Benjamin Thomas Marchello Ph: 800-648-6274
 Billings Clinic-Cody
 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
ClinicalTrials.gov processed this data on November 12, 2014

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

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