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

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentActive18 and overNCINCI-2009-01173
CDR0000634119, ECOG-E2905, E2905, U10CA180820, U10CA021115, 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 cells. 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-/intermediate-1 (Int-1)-risk myelodysplastic syndrome (MDS) patients or erythropoietin treatment naïve 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 CD71^Hi 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 up for 6 months.

Eligibility Criteria

Inclusion Criteria:

  • NOTE: Results of the bone marrow biopsy and aspirate as well as cytogenetics are mandatory to register subjects onto study, which are indispensable to determine International Prognostic Scoring System (IPSS) category needed for eligibility; please note that it is not necessary to wait for the week 16, week 32, or week bone marrow and cytogenetic results prior to starting the next cycle unless deemed necessary by the treating physician; one example of this exception can include if the subject shows signs of progression, such as increased peripheral blood blast percentage; at that juncture, the treating physician may prefer to await the results prior to starting a new cycle; if a cycle is started, and based on the bone marrow results it is felt by the treating physician that the subject should not continue on treatment, please be sure to note this information on the case report forms at end of treatment
  • 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 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 packed (p)RBC/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 be 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 discontinuation of lenalidomide therapy; females of 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 seizure 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 List, Principal 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

    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 Center - Kaiser Foundation Hospital - San Diego

    Han A Koh
    Ph: 626-564-3455

    Kaiser Permanente Medical Office -Vandever Medical Office

    Han A Koh
    Ph: 626-564-3455

    San Marcos

    Kaiser Permanente Health Care

    Han A Koh
    Ph: 626-564-3455

    Woodland Hills

    Kaiser Permanente Medical Cener - Woodland Hills

    Han A Koh
    Ph: 626-564-3455

    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

    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

    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

    Keren Sturtz
    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

    Keren Sturtz
    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
    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

    Delaware
    Lewes

    Tunnell Cancer Center at Beebe Medical Center

    Gregory A. Masters
    Ph: 302-733-6227

    Newark

    Delaware Clinical and Laboratory Physicians

    Gregory A. Masters
    Ph: 302-733-6227

    Helen F. Graham Cancer Center at Christiana Hospital

    Gregory A. Masters
    Ph: 302-733-6227

    Gregory A. Masters
    Ph: 302-733-6227

    Medical Oncology Hematology Consultants, PA at Helen F. Graham Cancer Center

    Gregory A. Masters
    Ph: 302-733-6227

    Regional Hematology/Oncology, PA - Newark

    Gregory A. Masters
    Ph: 302-733-6227

    Rehoboth Beach

    Beebe Health Campus

    Gregory A. Masters
    Ph: 302-733-6227

    Seaford

    Nanticoke Memorial 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

    Mayo Clinic - Jacksonville

    Mark R. Litzow
    Ph: 507-538-7623

    Leesburg

    Leesburg Regional Medical Center

    Pablo C Reyes
    Email: info@cfhalliance.org

    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
    Bloomington

    Illinois CancerCare - Bloomington

    James L. Wade
    Ph: 217-876-4740
    Email: kcheek@dmhhs.org

    Canton

    Illinois CancerCare - Canton

    James L. Wade
    Ph: 217-876-4740
    Email: kcheek@dmhhs.org

    Carthage

    Illinois CancerCare - Carthage

    James L. Wade
    Ph: 217-876-4740
    Email: kcheek@dmhhs.org

    Chicago

    Louis A. Weiss Memorial Hospital

    Keith L. Shulman
    Ph: 773-564-5044

    Resurrection Medical Center

    Christopher G. Rose
    Ph: 773-792-5116

    University of Chicago Cancer Research Center

    Andrew S Artz
    Ph: 773-834-7424

    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

    Elmhurst

    Elmhurst Memorial Hospital

    Lucio Di Nunno
    Ph: 630-782-7900
    Email: Jrohde@emhc.org

    Eureka

    Illinois CancerCare - Eureka

    James L. Wade
    Ph: 217-876-4740
    Email: kcheek@dmhhs.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

    Kewanee

    Illinois CancerCare - Kewanee Clinic

    James L. Wade
    Ph: 217-876-4740
    Email: kcheek@dmhhs.org

    Macomb

    Illinois CancerCare - Macomb

    James L. Wade
    Ph: 217-876-4740
    Email: kcheek@dmhhs.org

    Ottawa

    Illinois CancerCare - Ottawa

    James L. Wade
    Ph: 217-876-4740
    Email: kcheek@dmhhs.org

    Pekin

    Illinois CancerCare - Pekin

    James L. Wade
    Ph: 217-876-4740
    Email: kcheek@dmhhs.org

    Peoria

    Illinois CancerCare - Peoria

    James L. Wade
    Ph: 217-876-4740
    Email: kcheek@dmhhs.org

    Peru

    Illinois CancerCare - Princeton

    James L. Wade
    Ph: 217-876-4740
    Email: kcheek@dmhhs.org

    Princeton

    Illinois CancerCare - Princeton

    James L. Wade
    Ph: 217-876-4740
    Email: kcheek@dmhhs.org

    Rockford

    Advanced Care and Treatment Medical Group, PC

    Harvey Eric Einhorn
    Ph: 779-696-9400
    Email: cancercare@swedishamerican.org

    Springfield

    Central Illinois Hematology Oncology Center

    James L. Wade
    Ph: 217-876-4740
    Email: kcheek@dmhhs.org

    Regional Cancer Center at Memorial Medical Center

    James L. Wade
    Ph: 217-876-4740
    Email: kcheek@dmhhs.org

    Indiana
    Elkhart

    Michiana Hematology-Oncology, PC - Elkhart

    Bilal Ansari
    Ph: 574-237-1328

    Indianapolis

    Central Indiana Cancer Centers - East

    Hillary H Wu
    Ph: 317-356-2422

    Lafayette

    Clarian Arnett Cancer Care

    Thomas Isaac Jones
    Ph: 765-838-6871
    Email: thimes@iuhealth.org

    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

    Clive

    Medical Oncology and Hematology Associates-West Des Moines

    Mehmet S. Copur
    Ph: 800-998-2119

    Mercy Cancer Center - West Lakes

    Mehmet S. Copur
    Ph: 800-998-2119

    Des Moines

    Medical Oncology and Hematology Associates at Mercy Cancer Center

    Mehmet S. Copur
    Ph: 800-998-2119

    Mercy Cancer Center at Mercy Medical Center - Des Moines

    Mehmet S. Copur
    Ph: 800-998-2119

    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

    Praveen Vikas
    Ph: 641-684-2742

    Sioux City

    Siouxland Hematology-Oncology Associates, LLP

    Donald Bruce Wender
    Ph: 712-252-0088

    West Des Moines

    Methodist West Hospital

    Mehmet S. Copur
    Ph: 800-998-2119

    Kansas
    Lawrence

    Lawrence Memorial Hospital

    Shaker R. Dakhil
    Ph: 316-262-4467

    Wichita

    Wesley Medical Center

    Shaker R. Dakhil
    Ph: 316-262-4467

    Kentucky
    Louisville

    Jewish Hospital

    Mehmet S. Copur
    Ph: 800-998-2119

    Jewish Hospital Medical Center Northeast

    Mehmet S. Copur
    Ph: 800-998-2119

    Maryland
    Baltimore

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Amy E DeZern
    Ph: 410-955-8804
    Email: jhcccro@jhmi.edu

    St. Agnes Hospital Cancer Center

    Carole Miller
    Ph: 410-368-2910

    Bethesda

    National Naval Medical Center

    Corey A Carter
    Ph: 800-411-1222

    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

    Dearborn

    Oakwood Cancer Center at Oakwood Hospital and Medical Center

    Philip J. Stella
    Ph: 734-712-4673

    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

    Flint

    Genesys Hurley Cancer Institute

    Philip J. Stella
    Ph: 734-712-4673

    Iron Mountain

    Green Bay Oncology - Iron Mountain

    Brian L Burnette
    Ph: 800-432-6049

    Jackson

    Gayle M. Jacob Cancer Center at Allegiance Health

    Philip J. Stella
    Ph: 734-712-4673

    Kalamazoo

    West Michigan Cancer Center

    Sunil Nagpal
    Ph: 269-373-7458

    Livonia

    St. Mary Mercy Hospital

    Philip J. Stella
    Ph: 734-712-4673

    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

    Saginaw

    Seton Cancer Institute at Saint Mary's - Saginaw

    Philip J. Stella
    Ph: 734-712-4673

    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

    Duluth

    CCOP - Duluth

    Bret E Friday
    Ph: 888-203-7267

    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

    Health Partners Inc

    Patrick J. Flynn
    Ph: 952-993-1517
    Email: MMCCOP@parknicollet.com

    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

    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

    Missouri
    Cape Girardeau

    Saint Francis Medical Center

    James L. Wade
    Ph: 217-876-4740
    Email: kcheek@dmhhs.org

    Southeast Cancer Center

    Bryan A Faller
    Ph: 800-392-0936

    Columbia

    Ellis Fischel Cancer Center at University of Missouri - Columbia

    Clint D Kingsley
    Ph: 573-882-7440

    Jefferson City

    Goldschmidt Cancer Center

    Bryan A Faller
    Ph: 800-392-0936

    Kansas City

    Saint Luke's Hospital

    Rakesh Gaur
    Ph: 913-948-5588
    Email: aroland@kccop.org

    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

    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

    Nebraska
    Grand Island

    Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center

    Mehmet S. Copur
    Ph: 800-998-2119

    Kearney

    Good Samaritan Cancer Center at Good Samaritan Hospital

    Mehmet S. Copur
    Ph: 800-998-2119

    Lincoln

    Cancer Resource Center - Lincoln

    Gamini S. Soori
    Ph: 402-991-8070
    Email: mwilwerding@mvcc.cc

    Nevada
    Las Vegas

    Cancer and Blood Specialists-Fort Apache

    John Allan Ellerton
    Ph: 702-384-0013

    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

    Robert A Somer
    Ph: 856-325-6757

    East Orange

    Veterans Affairs Medical Center - East Orange

    Victor T Chang
    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

    Mineola

    Winthrop University Hospital

    Harry Staszewski
    Ph: 866-946-8476

    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
    Clinton

    Southeastern Medical Oncology Center-Clinton

    James N. Atkins
    Ph: 919-580-0000

    Goldsboro

    Southeastern Medical Oncology Center - Goldsboro

    James N. Atkins
    Ph: 919-580-0000

    Wayne Memorial Hospital, Incorporated

    James N. Atkins
    Ph: 919-580-0000

    Jacksonville

    Southeastern Medical Oncology Center-Jacksonville

    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

    Wilson

    Southeastern Medical Oncology Center - Wilson

    James N. Atkins
    Ph: 919-580-0000

    Winston-Salem

    Wake Forest University Comprehensive Cancer Center

    Bayard L. Powell
    Ph: 336-713-6771

    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

    Cincinnati

    Good Samaritan Hospital Cancer Treatment Center

    Mehmet S. Copur
    Ph: 800-998-2119

    TriHealth Cancer Institute-Anderson

    Mehmet S. Copur
    Ph: 800-998-2119

    TriHealth Cancer Institute-Westside

    Mehmet S. Copur
    Ph: 800-998-2119

    Lima

    St. Rita's Medical Center

    Henry Gerad
    Ph: 419-226-9617

    Sylvania

    Flower Hospital Cancer Center

    Rex B Mowat
    Ph: 800-444-3561

    Toledo

    Toledo Clinic, Incorporated - Main Clinic

    Rex B Mowat
    Ph: 800-444-3561

    University of Toledo Medical Center

    Rex B Mowat
    Ph: 800-444-3561

    Oklahoma
    Oklahoma City

    Stephenson Cancer Center at the University of Oklahoma

    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

    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

    Ephrata

    Ephrata Cancer Center at Ephrata Community Hospital

    Wilfred A Layne
    Ph: 717-738-4070

    Wilfred A Layne
    Ph: 717-738-4070

    Gettysburg

    Adams Cancer Center

    Wilfred A Layne
    Ph: 717-738-4070

    Hanover

    Cherry Tree Cancer Center

    Wilfred A Layne
    Ph: 717-738-4070

    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

    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

    Pottstown

    Pottstown Memorial Regional Cancer Center

    Wei Song
    Ph: 610-327-7544

    Sayre

    Guthrie Cancer Center at Guthrie Clinic Sayre

    Bradley W Lash
    Ph: 800-836-0388

    State College

    Mount Nittany Medical Center

    David F Claxton
    Ph: 717-531-3779
    Email: CTO@hmc.psu.edu

    West Chester

    Cancer Center of Chester County

    William E. Luginbuhl
    Ph: 610-431-5297

    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

    York

    WellSpan Health

    Wilfred A Layne
    Ph: 717-738-4070

    South Carolina
    Easley

    Cancer Centers of the Carolinas - Easley

    Jeffrey Kent Giguere
    Ph: 864-241-6251

    Greenville

    Bon Secours St. Francis Health System

    Robert D. Siegel
    Ph: 864-255-1713

    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
    Rapid City

    Rapid City Regional Hospital

    Joshua C Lukenbill
    Ph: 605-716-3982
    Email: research@rcrh.org

    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

    Danville

    Danville Regional Medical Center

    Qiwei W Gai
    Ph: 434-793-0044

    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

    Burlington

    Aurora Cancer Care-Burlington

    Dhimant R. Patel
    Ph: 800-252-2990

    Eau Claire

    Marshfield Clinic Cancer Care at Regional Cancer Center

    Bilal H Naqvi
    Ph: 800-839-3956

    Elkhorn

    Vince Lombardi Cancer Center at Aurora Lakeland Medical Center - Elkhorn

    Dhimant R. Patel
    Ph: 800-252-2990

    Grafton

    Aurora Cancer Care-Grafton

    Dhimant R. Patel
    Ph: 800-252-2990

    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

    Kenosha

    Oncology Alliance - Kenosha South

    Dhimant R. Patel
    Ph: 800-252-2990

    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

    Vince Lombardi Cancer Clinic - Marinette

    Dhimant R. Patel
    Ph: 800-252-2990

    Marshfield

    Marshfield Clinic - Marshfield Center

    Bilal H Naqvi
    Ph: 800-839-3956

    Saint Joseph's Hospital

    Bilal H Naqvi
    Ph: 800-839-3956

    Menomonee Falls

    Aurora Advanced Healthcare Inc-Menomonee Falls

    Dhimant R. Patel
    Ph: 800-252-2990

    Milwaukee

    Aurora Cancer Care-Milwaukee

    Dhimant R. Patel
    Ph: 800-252-2990

    Aurora Sinai Medical Center

    Dhimant R. Patel
    Ph: 800-252-2990

    Froedtert Hospital and Medical College of Wisconsin

    Ehab L Atallah
    Ph: 414-805-4380

    Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center

    Dhimant R. Patel
    Ph: 800-252-2990

    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

    Racine

    Aurora Health Center - Racine

    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

    Aurora Cancer Care-Waukesha

    Dhimant R. Patel
    Ph: 800-252-2990

    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

    Wauwatosa

    Oncology Alliance, SC - Milwaukee - West

    Dhimant R. Patel
    Ph: 800-252-2990

    West Allis

    Aurora Women's Pavilion of West Allis Memorial Hospital

    Dhimant R. Patel
    Ph: 800-252-2990

    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 Identifier NCT00843882
    ClinicalTrials.gov processed this data on May 20, 2015

    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.