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Clinical Trials (PDQ®)

Lenalidomide With or Without Epoetin Alfa in Treating Patients With Myelodysplastic Syndrome and Anemia

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentActive18 and overNCINCI-2009-01173
CDR0000634119, U10CA021115, ECOG-E2905, E2905, U10CA180820, NCT00843882

Trial Description

Summary

This randomized phase III trial studies lenalidomide to see how well it works with or without epoetin alfa in treating patients with myelodysplastic syndrome and anemia. Lenalidomide may stop the growth of myelodysplastic syndrome by blocking blood flow to the cell. Colony stimulating factors, such as epoetin alfa, may increase the number of immune cells found in bone marrow or peripheral blood. It is not yet known whether lenalidomide is more effective with or without epoetin alfa in treating patients with myelodysplastic syndrome and anemia.

Further Study Information

PRIMARY OBJECTIVES:

I. To compare the rate of major erythroid response (MER) between lenalidomide monotherapy and combined treatment of lenalidomide and epoetin alfa in erythropoietin non-responsive low- or intermediate-1 (Int-1)-risk myelodysplastic syndrome (MDS) patients or erythropoietin treatment naive patients with low probability of erythropoietin benefit.

SECONDARY OBJECTIVES:

I. To compare the time to MER by treatment assignment. II. To evaluate the duration of MER by treatment assignment. III. To estimate the frequency of MER to salvage combination therapy in patients who fail to experience a MER with lenalidomide monotherapy.

IV. To evaluate and compare the frequency of minor erythroid response by treatment assignment.

V. To investigate the mechanism and target of lenalidomide action in patients with chromosome 5q31.1 deletion.

VI. To evaluate the frequency of cytogenetic response and progression, and the relationship between cytogenetic pattern and erythroid response.

VII. To evaluate the frequency of bone marrow response (complete response [CR] + partial response [PR]).

VIII. To evaluate the relationship between erythroid response and laboratory correlates outlined below: pretreatment and on study endogenous erythropoietin level (Arm A); to evaluate the effect of cluster of differentiation (CD)45 isoform profile on lenalidomide enhancement of erythropoietin-induced signal transducer and activator of transcription 5A (STAT5) phosphorylation in CD71Hi erythroid precursors and the relationship to erythroid response; to characterize molecular targets relevant to lenalidomide cytotoxicity in del5q31.1 cells; to evaluate the frequency of cryptic chromosome 5q31.1 deletions in patients with non-del5q31.1 MDS by array-based genomic scan, and to determine the relationship to hematologic response.

OUTLINE: Patients are randomized to 1 of 2 treatment arms. Patients with del 5q31.1 karyotype are assigned to Arm A.

ARM A: Patients receive lenalidomide orally (PO) once daily (QD) on days 1-21.

ARM B: Patients receive lenalidomide PO QD on days 1-21 and epoetin alfa subcutaneously (SC) once weekly.

In both arms, treatment repeats every 28 days for 4 courses. Patients who achieve a major erythroid response (MER) may continue treatment beyond 4 courses in the absence of disease progression, disease conversion to acute myeloid leukemia, or unacceptable toxicity. Patients in Arm A who fail to achieve MER or who achieve MER but relapse after 16 weeks of treatment with lenalidomide may crossover and receive treatment in Arm B.

After completion of study treatment, patients are followed for 6 months.

Eligibility Criteria

Inclusion Criteria:

  • Patient must have documented diagnosis of MDS lasting at least three months (MDS duration >= 3 months) according to World Health Organization (WHO) criteria or non-proliferative chronic myelomonocytic leukemia (CMML) (white blood cell [WBC] < 12,000/mcL)
  • Patient must have International Prognostic Scoring System (IPSS) categories of low- or intermediate-1-risk disease; patients must have IPSS score determined by cytogenetic analysis prior to randomization; patients must have cytogenetic analysis done (to calculate IPSS); if the current bone marrow biopsy is a dry tap, patients with cytogenetic failure and < 10% marrow blasts will be eligible; subjects with cytogenetic failure must have previous cytogenetic results (fluorescence in situ hybridization [FISH] is not a substitute) within the last 6 months post last type of MDS treatment (in this case, not referring to growth factors as type of MDS treatment)
  • Must have symptomatic anemia untransfused with hemoglobin < 9.5 g/dL =< 8 weeks prior to randomization or with red blood cells (RBC) transfusion dependence (i.e., >= 2 units/month) confirmed for =< 8 weeks before randomization
  • NOTE: For non-transfusion dependent patients (i.e., receiving < 2 units/4 weeks x 8 weeks pre-study) who receive periodic transfusions, the mean 8 week pre-transfusion hemoglobin should be used to determine protocol eligibility and response reference
  • For non-transfusion dependent patients, a minimum of 2 pre-transfusion or un-transfused hemoglobin values are required
  • Applies only for patients without the deletion 5q 31.1; patients must have failed treatment with an erythropoietic growth factor, or have a low probability of response to rhu-erythropoietin; patients with low probability of response to rhu-erythropoietin or prior erythropoietin failures are defined as follows:
  • Prior erythropoietin failure-requires a minimum trial of >= 40,000 units epoetin alfa/week x 8 weeks or equivalent dose of darbepoetin alfa for 8 weeks with failure to achieve transfusion independence in dependent patients or a failure to achieve a >= 2 g rise in hemoglobin sustained for >= 4 weeks in non-transfusion dependent patients
  • Low erythropoietin response profile-rhu-erythropoietin and epoetin alfa-naïve patients receiving >= 2U pRBC/month for a minimum of 8 weeks, and serum erythropoietin > 500 mU/mL in the 8 weeks prior to randomization for a hemoglobin < 9.5 g/dL
  • Patients must be off all non-transfusion therapy for MDS for 28 days prior to initiation of study treatment, including all types of growth factors; patients may receive hydrocortisone prophylactically to prevent transfusion reactions
  • Patients must have a serum erythropoietin level documented before randomization and =< 56 days before day 1 of study treatment; NOTE: hemoglobin must be < 9.5 g/dL at time that serum erythropoietin is drawn
  • Patients must not have documented iron deficiency; all patients must have documented marrow iron stores; if marrow iron stain is not available, the transferrin saturation must be > 20% or a serum ferritin > 100 ng/mL
  • Women must not pregnant or breastfeeding; females of childbearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10-14 days and again within 24 hours prior to starting cycle 1 of lenalidomide; a female of childbearing potential (FCBP) is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months; FCBP must also agree to ongoing pregnancy testing
  • Effective contraception must be used by patients participating in lenalidomide therapy, and all patients must agree to counseling by a trained counselor every 28 days about pregnancy precautions and risks of fetal exposure; females of childbearing potential (FCBP) must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before starting lenalidomide, during lenalidomide therapy, during dose interruptions, and for at least 28 days following childbearing potential should be referred to a qualified provider of contraceptive methods, if needed; males receiving lenalidomide must agree to use a latex condom during any sexual contact with females of childbearing potential even if they have undergone a successful vasectomy
  • Patients must not have prior therapy with lenalidomide
  • Patients must not have a diagnosis of uncontrolled seizures or uncontrolled hypertension
  • Patients must not have proliferative (WBC >= 12,000/mcL) chronic myelomonocytic leukemia (CMML); WBC must be < 12,000/mcL
  • Patients must not have MDS secondary to treatment with radiotherapy, chemotherapy, and/or immunotherapy for malignant or autoimmune diseases
  • Platelet count >= 50,000/mcL (50 x 10^9/L) without platelet transfusion
  • Absolute neutrophil count (ANC) >= 500 cells/mcL (0.5 x 10^9/L); hence ANC must be >= 500/mcL without myeloid growth factor support
  • Serum creatinine =< 1.5 times upper limit of normal (ULN)
  • Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) or serum glutamate pyruvate transaminase (SGPT)/alanine aminotransferase (ALT) =< 2.0 x ULN
  • Serum total bilirubin < 3.0 mg/dL
  • Prior thalidomide is allowed, however, patients must not have prior >= grade-3 allergic reactions to thalidomide
  • Patients must not have prior history of desquamating rash from thalidomide at time of study entry
  • Patients must not have clinically significant anemia resulting from iron, B12 or folate deficiencies, autoimmune or hereditary hemolysis, or gastrointestinal bleeding
  • Patients must not have used cytotoxic chemotherapeutic agents or experimental agents (agents that are not commercially available) for the treatment of MDS within 8 weeks of randomization
  • Patients must not have prior history of malignancy other than MDS (except basal cell or squamous skin cell carcinoma or carcinoma in situ of the cervix or breast) unless the subject has been confirmed free of disease for >= 3 years
  • Patients must not have any serious medical condition or any other unstable medical co-morbidity, or psychiatric illness that will prevent the subject from signing the informed consent form or will place the subject at unacceptable risk if he/she participates in the study
  • Patients must not have a history of thrombo-embolic events within 3 years prior to study randomization
  • Patients must not have known human immunodeficiency virus (HIV)-1 seropositivity
  • Patients must not have a known allergic reaction to epoetin alfa (Procrit) or human serum albumin
  • Eligibility for crossover registration from Arm A (lenalidomide alone) to Arm B (lenalidomide and epoetin alfa):
  • Patients must have completed 16 weeks of monotherapy with lenalidomide
  • Patients must show failure to achieve MER (major erythroid response) or have achieved MER but relapsed on Arm A
  • Patients must not have a limiting unresolved grade 3 or greater toxicity from lenalidomide monotherapy or drug intolerance preventing continuation of lenalidomide treatment

Trial Contact Information

Trial Lead Organizations/Sponsors

National Cancer Institute

Alan ListPrincipal Investigator

Trial Sites

U.S.A.
Alabama
  Birmingham
 UAB Comprehensive Cancer Center
 Uma M Borate Ph: 205-934-0309
Arizona
  Scottsdale
 Mayo Clinic Scottsdale
 Mark R. Litzow Ph: 507-538-7623
  Tucson
 Arizona Cancer Center at University Medical Center North
 Ravitharan Krishnadasan Ph: 520-626-9008
 Arizona Cancer Center at University of Arizona Health Sciences Center
 Ravitharan Krishnadasan Ph: 520-626-9008
California
  Baldwin Park
 Kaiser Permanente Medical Center - Baldwin Park
 Han A Koh Ph: 626-564-3455
  Greenbrae
 Marin Cancer Institute at Marin General Hospital
 Peter D. Eisenberg Ph: 415-925-5000
  Email: info@marinspecialtycare.com
  Irvine
 Kaiser Permanente - Irvine
 Han A Koh Ph: 626-564-3455
  Los Angeles
 Kaiser Permanente Medical Center - Los Angeles
 Han A Koh Ph: 626-564-3455
  Panorama City
 Kaiser Permanente Medical Group
 Han A Koh Ph: 626-564-3455
  Sacramento
 University of California Davis Cancer Center
 Jeanna L Welborn Ph: 916-734-3089
  Saint Helena
 Saint Helena Hospital
 Gregory B Smith Ph: 707-967-3698
  San Diego
 Kaiser Permanente - Mission
 Han A Koh Ph: 626-564-3455
 Kaiser Permanente Medical Office -Vandever Medical Office
 Han A Koh Ph: 626-564-3455
  Stanford
 Stanford Cancer Center
 Peter L. Greenberg Ph: 650-498-7061
  Email: ccto-office@stanford.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
  Colorado Springs
 Penrose Cancer Center at Penrose Hospital
 Keren Sturtz Ph: 888-785-6789
  Denver
 CCOP - Colorado Cancer Research Program
 Keren Sturtz Ph: 888-785-6789
 Colorado Blood Cancer Institute
 Keren Sturtz Ph: 888-785-6789
 Porter Adventist Hospital
 Keren Sturtz Ph: 888-785-6789
 Presbyterian - St. Luke's Medical Center
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers - Denver Midtown
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers-Rose
 Keren Sturtz Ph: 888-785-6789
 Rose Medical Center
 Keren Sturtz Ph: 888-785-6789
 St. Joseph Hospital
 Keren Sturtz Ph: 888-785-6789
  Durango
 Mercy Medical Center
 Cynthia K. Cathcart Ph: 888-785-6789
  Englewood
 Comprehensive Cancer Care and Research Institute of Colorado LLC
 Keren Sturtz Ph: 888-785-6789
 Swedish Medical Center
 Keren Sturtz Ph: 888-785-6789
  Fort Collins
 Poudre Valley Hospital
 Regina J Brown Ph: 970-297-6150
  Golden
 Mountain Blue Cancer Care Center
 Keren Sturtz Ph: 888-785-6789
  Greeley
 North Colorado Medical Center
 Keren Sturtz Ph: 888-785-6789
  Greenwood Village
 Breast Cancer Care Consultants
 Keren Sturtz Ph: 888-785-6789
  Lakewood
 Rocky Mountain Cancer Centers-Lakewood
 Keren Sturtz Ph: 888-785-6789
 St. Anthony Central Hospital
 Keren Sturtz Ph: 888-785-6789
  Littleton
 Littleton Adventist Hospital
 Keren Sturtz Ph: 888-785-6789
  Lone Tree
 Rocky Mountain Cancer Centers - Lone Tree
 Keren Sturtz Ph: 888-785-6789
 Sky Ridge Medical Center
 Eduardo R. Pajon Ph: 888-785-6789
  Longmont
 Hope Cancer Care Center at Longmont United Hospital
 Keren Sturtz Ph: 888-785-6789
  Loveland
 McKee Medical Center
 Keren Sturtz Ph: 888-785-6789
  Parker
 Parker Adventist Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers - Parker
 Keren Sturtz Ph: 888-785-6789
  Pueblo
 St. Mary - Corwin Regional Medical Center
 Keren Sturtz Ph: 888-785-6789
  Wheat Ridge
 Exempla Lutheran Medical Center
 Keren Sturtz Ph: 888-785-6789
Connecticut
  Farmington
 Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
 Jeffrey S. Wasser Ph: 800-579-7822
  Hartford
 Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
 Philip J. Stella 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
  New Haven
 Yale Cancer Center
 Steven D. Gore Ph: 203-785-5702
  Email: jhcccro@jhmi.edu
Delaware
  Lewes
 Tunnell Cancer Center at Beebe Medical Center
 Gregory A. Masters Ph: 302-733-6227
  Newark
 Helen F. Graham Cancer Center at Christiana Hospital
 Gregory A. Masters Ph: 302-733-6227
Florida
  Hollywood
 Joe DiMaggio Children's Hospital
 Daren D Grosman Ph: 888-823-5923
  Email: ctsucontact@westat.com
  Jacksonville
 Baptist Cancer Institute - Jacksonville
 Troy Hancil Guthrie Ph: 904-202-7051
 Mayo Clinic - Jacksonville
 Mark R. Litzow Ph: 507-538-7623
  Leesburg
 Leesburg Regional Medical Center
 Pablo C Reyes
  Email: info@cfhalliance.org
  Miami
 Baptist-South Miami Regional Cancer Program
 Paul R Kaywin Ph: 800-599-2456
  Email: cancerinfo@baptisthealth.net
 University of Miami Sylvester Comprehensive Cancer Center - Miami
 Deborah Zipin Glick Ph: 866-574-5124
  Email: Sylvester@emergingmed.com
  Miami Beach
 CCOP - Mount Sinai Medical Center
 Michael Schwartz Ph: 305-674-2625
  Email: info@msccop.com
  Tampa
 H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
 Alan Francis List Ph: 800-456-7121
  Email: canceranswers@moffitt.org
Idaho
  Boise
 Mountain States Tumor Institute at St. Luke's Regional Medical Center
 Paul G. Montgomery Ph: 800-845-4624
 Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
 Philip J. Stella Ph: 734-712-4673
  Fruitland
 Saint Luke's Mountain States Tumor Institute - Fruitland
 Paul G. Montgomery Ph: 800-845-4624
  Meridian
 Mountain States Tumor Institute - Meridian
 Paul G. Montgomery Ph: 800-845-4624
  Nampa
 Saint Luke's Mountain States Tumor Institute
 Paul G. Montgomery Ph: 800-845-4624
  Post Falls
 Kootenai Cancer Center - Post Falls
 Benjamin Thomas Marchello Ph: 800-648-6274
  Twin Falls
 Mountain States Tumor Institute at St. Luke's
 Paul G. Montgomery Ph: 800-845-4624
Illinois
  Chicago
 Louis A. Weiss Memorial Hospital
 Keith L. Shulman Ph: 773-564-5044
 Robert H. Lurie Comprehensive Cancer Center at Northwestern University
 Olga Frankfurt Ph: 312-695-1301
  Email: cancer@northwestern.edu
 University of Chicago Cancer Research Center
 Andrew S Artz Ph: 773-834-7424
  Elmhurst
 Elmhurst Memorial Hospital
 Lucio Di Nunno Ph: 630-782-7900
  Email: Jrohde@emhc.org
  Evanston
 CCOP - Evanston
 David L. Grinblatt Ph: 847-570-2109
  Glenview
 Glenbrook Hospital
 David L. Grinblatt Ph: 847-570-2109
  Highland Park
 Highland Park Hospital
 David L. Grinblatt Ph: 847-570-2109
  Joliet
 Joliet Oncology-Hematology Associates, Limited - West
 Kulumani M Sivarajan Ph: 815-730-3098
  Email: maureenc@jolietoncology.com
  Niles
 Cancer Care and Hematology Specialists of Chicagoland - Niles
 Olga Frankfurt Ph: 312-695-1301
  Email: cancer@northwestern.edu
  Rockford
 Advanced Care and Treatment Medical Group, PC
 Harvey Eric Einhorn Ph: 779-696-9400
  Email: cancercare@swedishamerican.org
  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
  Elkhart
 Elkhart Clinic, LLC
 Bilal Ansari Ph: 574-237-1328
 Elkhart General Hospital
 Bilal Ansari Ph: 574-237-1328
 Michiana Hematology-Oncology, PC - Elkhart
 Bilal Ansari Ph: 574-237-1328
  Kokomo
 Community Cancer Care at Howard Regional Health System
 Bilal Ansari Ph: 574-237-1328
  La Porte
 Center for Cancer Therapy at LaPorte Hospital and Health Services
 Bilal Ansari Ph: 574-237-1328
  Lafayette
 Clarian Arnett Cancer Care
 Thomas Isaac Jones Ph: 800-899-8448ext7431
  Email: sstidham@clarianarnett.com
  Merrillville
 Premier Oncology Hematology Associates
 Bharat H. Barai Ph: 219-736-2800
  Mishawaka
 Michiana Hematology-Oncology, PC - Mishawaka
 Bilal Ansari Ph: 574-237-1328
 Saint Joseph's Medical Center
 Bilal Ansari Ph: 574-237-1328
  Plymouth
 Michiana Hematology Oncology PC - Plymouth
 Bilal Ansari Ph: 574-237-1328
  South Bend
 CCOP - Northern Indiana CR Consortium
 Bilal Ansari Ph: 574-237-1328
 Memorial Hospital of South Bend
 Thomas Joseph Reid Ph: 800-284-7370
 Michiana Hematology-Oncology, PC - South Bend
 Bilal Ansari Ph: 574-237-1328
  Westville
 Michiana Hematology Oncology-PC Westville
 Bilal Ansari Ph: 574-237-1328
Iowa
  Ames
 McFarland Clinic, PC
 Joseph James Merchant Ph: 515-239-2621
  Cedar Rapids
 Cedar Rapids Oncology Associates
 Deborah W Wilbur Ph: 319-363-2690
  Mason City
 Mercy Cancer Center at Mercy Medical Center - North Iowa
 Arvind Y Vemula Ph: 800-433-3883
  Ottumwa
 South Iowa Radiation Oncology Center at Ottumwa Regional Health Center
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
  Sioux City
 Siouxland Hematology-Oncology Associates, LLP
 Donald Bruce Wender Ph: 712-252-0088
Kansas
  Lawrence
 Lawrence Memorial Hospital
 Shaker R. Dakhil Ph: 316-262-4467
  Wichita
 Wesley Medical Center
 Shaker R. Dakhil Ph: 316-262-4467
Maryland
  Baltimore
 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
 Steven D. Gore Ph: 203-785-5702
  Email: jhcccro@jhmi.edu
 St. Agnes Hospital Cancer Center
 Carole Miller Ph: 410-368-2910
  Bethesda
 National Naval Medical Center
 David C Van Echo Ph: 301-319-2100
Massachusetts
  Burlington
 Lahey Clinic Medical Center - Burlington
 Alan Francis List Ph: 813-745-7101
  Email: alan.list@moffitt.org
  Worcester
 UMASS Memorial Cancer Center - University Campus
 Muthalagu Ramanathan Ph: 508-856-3216
  Email: cancer.research@umassmed.edu
Michigan
  Ann Arbor
 Saint Joseph Mercy Cancer Center
 Philip J. Stella Ph: 734-712-4673
 University of Michigan Comprehensive Cancer Center
 Dale L Bixby Ph: 800-865-1125
  Detroit
 Van Elslander Cancer Center at St. John Hospital and Medical Center
 Philip J. Stella Ph: 734-712-4673
 Wayne State University
 Charles A. Schiffer Ph: 313-576-9363
  Escanaba
 Green Bay Oncology, Limited - Escanaba
 Brian L Burnette Ph: 800-432-6049
  Iron Mountain
 Green Bay Oncology - Iron Mountain
 Brian L Burnette Ph: 800-432-6049
  Kalamazoo
 West Michigan Cancer Center
 Raymond Sterling Lord Ph: 269-373-7458
  Marquette
 Upper Michigan Cancer Center at Marquette General Hospital
 Amy Weise Ph: 313-576-9363
  Pontiac
 St. Joseph Mercy Oakland
 Philip J. Stella Ph: 734-712-4673
  Port Huron
 Mercy Regional Cancer Center at Mercy Hospital
 Philip J. Stella Ph: 734-712-4673
  Saint Joseph
 Lakeside Cancer Specialists, PLLC
 Bilal Ansari Ph: 574-237-1328
  Southfield
 Providence Hospital - Southfield
 Howard R. Terebelo Ph: 248-849-5337
  Email: jaswinder.grewal@stjohn.org
  St. Joseph
 Lakeland Regional Cancer Care Center - St. Joseph
 Bilal Ansari Ph: 574-237-1328
  Warren
 St. John Macomb Hospital
 Philip J. Stella Ph: 734-712-4673
Minnesota
  Burnsville
 Fairview Ridges Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Coon Rapids
 Mercy and Unity Cancer Center at Mercy Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Edina
 Fairview Southdale Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Fridley
 Mercy and Unity Cancer Center at Unity Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Hutchinson
 Hutchinson Area Health Care
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Maplewood
 HealthEast Cancer Care at St. John's Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Minnesota Oncology - Maplewood
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Minneapolis
 Hennepin County Medical Center - Minneapolis
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Veterans Affairs Medical Center - Minneapolis
 Sharon D Luikart Ph: 612-467-2800
 Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Robbinsdale
 Humphrey Cancer Center at North Memorial Outpatient Center
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Rochester
 Mayo Clinic Cancer Center
 Mark R. Litzow Ph: 507-538-7623
  Saint Cloud
 CentraCare Clinic - Women and Children
 Donald J Jurgens Ph: 877-229-4907
  Email: coborncancercenter@centracare.com
  Saint Louis Park
 CCOP - Metro-Minnesota
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Park Nicollet Cancer Center
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Saint Paul
 Regions Hospital Cancer Care Center
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 United Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Shakopee
 St. Francis Cancer Center at St. Francis Medical Center
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Waconia
 Ridgeview Medical Center
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Willmar
 Willmar Cancer Center at Rice Memorial Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Woodbury
 Minnesota Oncology - Woodbury
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
Mississippi
  Kessler AFB
 Keesler Air Force Base Medical Center
 Louis M Varner Ph: 800-700-8603
Missouri
  Columbia
 Ellis Fischel Cancer Center at University of Missouri - Columbia
 Donald C Doll Ph: 573-882-7440
  Kansas City
 Saint Luke's Hospital
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
 Veterans Affairs Medical Center - Kansas City
 Suman Kambhampati Ph: 800-525-1483
  Saint Louis
 Missouri Baptist Cancer Center
 Bryan A Faller Ph: 800-392-0936
 St. Anthony's Cancer Center
 Minxiang (Michael) Gu Ph: 888-823-5923
  Email: ctsucontact@westat.com
Montana
  Billings
 Billings Clinic Cancer Center - 801 N 29th Street
 Benjamin Thomas Marchello Ph: 800-648-6274
  Bozeman
 Bozeman Deaconess Cancer Center
 Benjamin Thomas Marchello Ph: 800-648-6274
Nebraska
  Grand Island
 Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center
 Lori J. Maness Ph: 800-999-5465
  Lincoln
 Cancer Resource Center - Lincoln
 Gamini S. Soori Ph: 800-253-4368
  Omaha
 UNMC Eppley Cancer Center at the University of Nebraska Medical Center
 Lori J. Maness Ph: 800-999-5465
Nevada
  Las Vegas
 CCOP - Nevada Cancer Research Foundation
 John Allan Ellerton Ph: 702-384-0013
New Hampshire
  Keene
 Kingsbury Center for Cancer Care at Cheshire Medical Center
 Steven S Larmon Ph: 603-354-5454ext2155
  Email: jmichelson@cheshire-med.com
New Jersey
  Camden
 Cancer Institute of New Jersey at Cooper University Hospital - Camden
 Gregory A. Masters Ph: 302-733-6227
  East Orange
 Veterans Affairs Medical Center - East Orange
 Basil S. Kasimis Ph: 800-475-2336
  Email: patricia.goyer@med.va.gov
  Newark
 Newark Beth Israel Medical Center
 Lori Schleicher Ph: 973-926-7230
  Vineland
 Frank and Edith Scarpa Regional Cancer Pavillion at South Jersey Healthcare
 Tami L Bach Ph: 856-641-7933
New York
  Bronx
 Jack D. Weiler Hospital at Montefiore Medical Center - East Campus
 Amit Verma Ph: 718-904-2730
  Email: aecc@aecom.yu.edu
 Montefiore Medical Center
 Amit Verma Ph: 718-904-2730
  Email: aecc@aecom.yu.edu
  East Syracuse
 CCOP - Hematology-Oncology Associates of Central New York
 Jeffrey J. Kirshner Ph: 315-472-7504
  Mineola
 Winthrop University Hospital
 Harry Staszewski Ph: 866-946-8476
  New York
 Memorial Sloan-Kettering Cancer Center
 Virginia M Klimek Ph: 212-639-7202
 New York University Medical Center
 Bruce Gordon Raphael Ph: 212-263-4434
  Email: prmc.coordinator@nyumc.org
  Rochester
 James P. Wilmot Cancer Center at University of Rochester Medical Center
 Jonathan W Friedberg Ph: 585-275-5830
North Carolina
  Goldsboro
 Wayne Memorial Hospital, Incorporated
 James N. Atkins Ph: 919-580-0000
  Raleigh
 Rex Cancer Center at Rex Hospital
 Jeremiah C Boles Ph: 919-784-7209
 Rex Cancer Center of Wakefield
 Jeremiah C Boles Ph: 919-784-7209
  Statesville
 Iredell Memorial Hospital
 Ruby A. Grimm Ph: 704-873-5661
North Dakota
  Bismarck
 Bismarck Cancer Center
 John T Reynolds Ph: 701-323-5760
  Email: tfischer@mohs.org
Ohio
  Canton
 Aultman Cancer Center at Aultman Hospital
 Kisa E Weeman Ph: 330-363-6891
 Mercy Cancer Center at Mercy Medical Center
 Mitchell Haut Ph: 888-293-4673
  Lima
 St. Rita's Medical Center
 Henry Gerad Ph: 419-226-9617
  Sylvania
 Flower Hospital Cancer Center
 Rex B Mowat Ph: 517-265-0116
  Toledo
 Toledo Clinic, Incorporated - Main Clinic
 Rex B Mowat Ph: 517-265-0116
 University of Toledo Medical Center
 Rex B Mowat Ph: 517-265-0116
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 Mohamad Cherry Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
Oregon
  Coos Bay
 Bay Area Hospital
 Bret A. Cook Ph: 541-269-8392
  Email: cherie.cox@bayareahospital.org
Pennsylvania
  Abington
 Rosenfeld Cancer Center at Abington Memorial Hospital
 Willard G. Andrews Ph: 215-481-2402
  Bryn Mawr
 Bryn Mawr Hospital
 Paul B. Gilman Ph: 484-476-2649
  Email: wellenbachj@mlhs.org
  Carlisle
 Carlisle Cancer Center
 David F Claxton Ph: 717-531-3779
  Email: CTO@hmc.psu.edu
  Danville
 Geisinger Cancer Institute at Geisinger Health
 Edward J Gorak Ph: 570-271-5251
  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
  Paoli
 Cancer Center of Paoli Memorial Hospital
 Paul B. Gilman Ph: 484-476-2649
  Email: wellenbachj@mlhs.org
  Philadelphia
 Abramson Cancer Center of the University of Pennsylvania
 Selina M. Luger Ph: 800-474-9892
  Phoenixville
 Cancer Center at Phoenixville Hospital
 Carl W. Sharer Ph: 610-983-1908
  Sayre
 Guthrie Cancer Center at Guthrie Clinic Sayre
 Philip A. Lowry Ph: 800-836-0388
  State College
 Mount Nittany Medical Center
 David F Claxton Ph: 717-531-3779
  Email: CTO@hmc.psu.edu
  West Reading
 McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
 Terrence P. Cescon Ph: 610-988-9323
  Wilkes-Barre
 Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
 Edward J Gorak Ph: 570-271-5251
  Williamsport
 Susquehanna Cancer Center at Divine Providence Hospital
 Warren L Robinson Ph: 800-598-4282
  Wynnewood
 CCOP - Main Line Health
 Paul B. Gilman Ph: 484-476-2649
  Email: wellenbachj@mlhs.org
 Lankenau Cancer Center at Lankenau Hospital
 Paul B. Gilman Ph: 484-476-2649
  Email: wellenbachj@mlhs.org
South Carolina
  Easley
 Cancer Centers of the Carolinas - Easley
 Jeffrey Kent Giguere Ph: 864-241-6251
  Greenville
 Cancer Centers of the Carolinas - Faris Road
 Jeffrey Kent Giguere Ph: 864-241-6251
 Cancer Centers of the Carolinas - Grove Commons
 Jeffrey Kent Giguere Ph: 864-241-6251
 CCOP - Greenville
 Jeffrey Kent Giguere Ph: 864-241-6251
 Greenville Memorial Hospital
 Jeffrey Kent Giguere Ph: 864-241-6251
  Greer
 Cancer Centers of the Carolinas - Greer Radiation Oncology
 Jeffrey Kent Giguere Ph: 864-241-6251
  Seneca
 Cancer Centers of the Carolinas - Seneca
 Jeffrey Kent Giguere Ph: 864-241-6251
  Spartanburg
 Cancer Centers of the Carolinas - Spartanburg
 Jeffrey Kent Giguere Ph: 864-241-6251
South Dakota
  Sioux Falls
 Avera Cancer Institute
 Addison R Tolentino Ph: 800-657-4377
  Email: Jan.Healy@avera.org
Tennessee
  Knoxville
 Thompson Cancer Survival Center
 Samuel Spence McCachren Ph: 865-541-1812
Virginia
  Charlottesville
 University of Virginia Cancer Center
 Michael Eugene Williams Ph: 434-243-6143
  Martinsville
 Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
 Sreedhar Katragadda Ph: 276-666-7827
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
  Princeton
 Princeton Community Hospital
 Rowena Gonzales-Chambers Ph: 304-487-7000
Wisconsin
  Appleton
 Fox Valley Hematology and Oncology - East Grant Street
 Timothy F Goggins Ph: 920-749-1171
  Eau Claire
 Marshfield Clinic Cancer Care at Regional Cancer Center
 Bilal H Naqvi Ph: 800-839-3956
  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
 Dhimant R. Patel Ph: 800-252-2990
  Janesville
 Mercy Regional Cancer Center
 Robert Delaune Ph: 800-928-1103
  La Crosse
 Gundersen Lutheran Center for Cancer and Blood
 Kurt Oettel Ph: 608-775-2385
  Email: cancerctr@gundluth.org
  Madison
 Dean Hematology & Oncology Clinic
 Amit Sanyal Ph: 608-410-2700
  Marinette
 Bay Area Cancer Care Center at Bay Area Medical Center
 Brian L Burnette Ph: 800-432-6049
  Marshfield
 Marshfield Clinic - Marshfield Center
 Bilal H Naqvi Ph: 800-839-3956
 Saint Joseph's Hospital
 Bilal H Naqvi Ph: 800-839-3956
  Milwaukee
 Froedtert Hospital and Medical College of Wisconsin
 Ehab L Atallah Ph: 414-805-4380
  Minocqua
 Marshfield Clinic - Lakeland Center
 Bilal H Naqvi Ph: 800-839-3956
  Oconomowoc
 Regional Cancer Center at Oconomowoc Memorial Hospital
 Timothy R Wassenaar Ph: 262-928-7878
  Oconto Falls
 Green Bay Oncology, Limited - Oconto Falls
 Brian L Burnette Ph: 800-432-6049
  Oshkosh
 Vince Lombardi Cancer Clinic - Oshkosh
 Dhimant R. Patel Ph: 800-252-2990
  Rhinelander
 Ministry Medical Group at Saint Mary's Hospital
 Bilal H Naqvi Ph: 800-839-3956
  Rice Lake
 Marshfield Clinic - Indianhead Center
 Bilal H Naqvi Ph: 800-839-3956
  Sheboygan
 Vince Lombardi Cancer Clinic - Sheboygan
 Dhimant R. Patel Ph: 800-252-2990
  Stevens Point
 Marshfield Clinic at Saint Michael's Hospital
 Bilal H Naqvi Ph: 800-839-3956
  Sturgeon Bay
 Green Bay Oncology, Limited - Sturgeon Bay
 Brian L Burnette Ph: 800-432-6049
  Summit
 Aurora Medical Center
 Dhimant R. Patel Ph: 800-252-2990
  Two Rivers
 Vince Lombardi Cancer Clinic - Two Rivers
 Dhimant R. Patel Ph: 800-252-2990
  Waukesha
 Waukesha Memorial Hospital Regional Cancer Center
 Timothy R Wassenaar Ph: 262-928-7878
  Wausau
 University of Wisconcin Cancer Center at Aspirus Wausau Hospital
 Hamied R. Rezazadeh Ph: 877-405-6866
  Weston
 Marshfield Clinic - Weston Center
 Bilal H Naqvi Ph: 800-839-3956
  Wisconsin Rapids
 Marshfield Clinic - Wisconsin Rapids Center
 Bilal H Naqvi Ph: 800-839-3956
 Riverview UW Cancer Center at Riverview Hospital
 Ron James Kirschling Ph: 877-405-6866

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00843882
ClinicalTrials.gov processed this data on August 19, 2014

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

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