Lenalidomide or Observation in Treating Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase III, Phase IIBiomarker/Laboratory analysis, TreatmentActive18 and overNCINCI-2011-02057
ECOG-E3A06, CDR0000682012, E3A06, U10CA180820, U10CA021115, NCT01169337

Trial Description

Summary

This randomized phase II/III trial studies how well lenalidomide works and compares it to observation in treating patients with asymptomatic high-risk asymptomatic (smoldering) multiple myeloma. Biological therapies such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Sometimes the cancer may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether lenalidomide is effective in treating patients with high-risk smoldering multiple myeloma than observation alone.

Further Study Information

PRIMARY OBJECTIVES:

I. To study the risk of grade 3 adverse events that affect vital organ function (such as cardiac, hepatic or thromboembolic) or any grade 4 or higher non-hematologic adverse events among patients receiving lenalidomide as treatment for high-risk asymptomatic, smoldering multiple myeloma. (Phase II) II. To compare progression free survival where failure is defined as death or the development of symptomatic myeloma indicating treatment between patients receiving lenalidomide versus observation alone in high-risk asymptomatic, smoldering multiple myeloma. (Phase III)

SECONDARY OBJECTIVES:

I. To assess the response to therapy of patients treated with lenalidomide as treatment for asymptomatic, smoldering multiple myeloma. (Phase II) II. To determine and compare the response rate, time to progression, 1-year progression-free survival probability, and overall survival between patients randomized to receive lenalidomide or observation in the setting of asymptomatic myeloma. (Phase III) III. To estimate the incidence of adverse events in patients receiving lenalidomide therapy for early-stage multiple myeloma. (Phase III)

TERTIARY OBJECTIVES:

I. To describe the cohort in terms of gene expression profiling (GEP) and cytogenetic risk classification and evaluate baseline immune and magnetic resonance imaging (MRI) parameters. (Phase II) II. To evaluate the impact of therapy within GEP-defined risk groups and GEP as a prognostic marker. (Phase III) III. To study the effects of lenalidomide on laboratory markers of immune function. (Phase III) IV. To study the prognostic value of MRI-detected asymptomatic bone disease on clinical outcome. (Phase III V. To evaluate the prognostic effect of baseline high-risk cytogenetic abnormalities on clinical outcome. (Phase III)

QUATERNARY OBJECTIVES:

I. To compare quality of life (QOL) change between treatment and observation arms based on the functional (FWB) and physical (PWB) well-being components of the Functional Assessment of Cancer Therapy (FACT)-General (G) patient-reported outcome (PRO) measure from registration (prior to initiation of treatment) up to cycle 24.

II. To examine the impact of differential treatment response (PFS), if observed, on QOL based on the FACT FWB+PWB up to cycle 48.

III. To obtain prospective data on myeloma specific QOL attributes, utilizing and evaluating the Multiple Myeloma Subscale (MMS).

OUTLINE:

PHASE II: Patients receive lenalidomide orally (PO) once daily (QD) on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

PHASE III: Patients are randomized to 1 of 2 treatment arms.

ARM A: Patients receive lenalidomide PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM B: Patients undergo observation until progression to symptomatic myeloma.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then every 12 months for 5 years.

Eligibility Criteria

Inclusion Criteria:

  • Patients must be diagnosed with asymptomatic high-risk smoldering multiple myeloma (SMM) within the past 60 months, as confirmed by both of the following:
  • Bone marrow plasmacytosis with >= 10% plasma cells or sheets of plasma cells at any time before initiating study treatment, including a marrow which must be obtained by bone marrow aspiration and/or biopsy within 4 weeks prior to randomization
  • Abnormal serum free light chain ratio (< 0.26 or > 1.65) by serum free light chain (FLC) assay; FLC assay must be performed within 28 days of randomization
  • Patients must have measurable levels of monoclonal protein (M-protein): >= 1g/dL on serum protein electrophoresis or >= 200 mg of monoclonal protein on a 24 hour urine protein electrophoresis which must be obtained within 4 weeks prior to randomization
  • Patients must have no lytic lesions on skeletal surveys and no hypercalcemia (i.e., >= 11 mg/dL)
  • Hemoglobin >= 11 g/dL
  • Platelet count >= 100,000/mm^3
  • Absolute neutrophil count (ANC) >= 1,500/mm^3
  • Calculated creatinine clearance >= 30 mL/min
  • Bilirubin =< 1.5 mg/dL
  • Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) and serum glutamic oxaloacetic transaminase (SGPT) (aspartate aminotransferase [AST]) =< 2.5 times upper limit of normal
  • No prior or concurrent systemic or radiation therapy for the treatment of myeloma
  • Concurrent use of bisphosphonates is not permitted; however, prior bisphosphonates or once-a-year intravenous bisphosphonate given for the treatment of osteoporosis is permitted
  • Prior or concurrent use of erythropoietin is disallowed
  • Prior glucocorticosteroid therapy for the treatment of multiple myeloma is not permitted
  • Prior systemic glucocorticosteroid use for the treatment of non-malignant disorders is permitted; concurrent use after registration on the study should be restricted to the equivalent of prednisone 10 mg per day
  • Prior or concurrent topical or localized glucocorticosteroid therapy to treat non-malignant comorbid disorders is permitted
  • Patients must not have active, uncontrolled seizure disorder; patients must have had no seizures in the last 6 months
  • Patients must not have uncontrolled intercurrent illness including uncontrolled hypertension, symptomatic congestive heart failure, unstable angina, uncontrolled cardiac arrhythmia, uncontrolled psychiatric illness or social situation that would limit compliance with the study, or a prior history of Stevens Johnson Syndrome
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
  • Patients must not have baseline bone lesions or plasmacytomas
  • Patients with monoclonal gammopathy of undetermined significance are not eligible
  • Patients must not have grade 2 or higher peripheral neuropathy
  • Patients must not have active, uncontrolled infection
  • Patients may have a history of current or previous deep vein thrombosis or pulmonary embolism but are required to take some form of anti-coagulation as prophylaxis if they are not currently on full-dose anticoagulation
  • Patients should not have New York Heart Association classification III or IV heart failure
  • Patients with a history of prior malignancy are eligible provided they were treated with curative intent and have been free of disease for the time period considered appropriate for cure of the specific cancer; for most diseases this time frame is 5 years
  • Patients should not be felt to have an immediate need for chemotherapy
  • Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days prior to and again within 24 hours of starting cycle 1 of lenalidomide and 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 she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy; a FCBP is a sexually mature woman who: 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); all patients must be counseled by a trained counselor every 28 days about pregnancy precautions and risks of fetal exposure
  • Human immunodeficiency virus (HIV) infection is not excluded; HIV+ patients must meet the following criteria:
  • Cluster of differentiation (CD)4 cell count >= 350/mm^3
  • No history of acquired immune deficiency syndrome (AIDS)-related illness
  • Not currently prescribed zidovudine or stavudine

Trial Contact Information

Trial Lead Organizations/Sponsors

National Cancer Institute

    Sagar Lonial, Principal Investigator

    Trial Sites

    U.S.A.

    Alaska
    Anchorage

    Alaska Breast Care and Surgery LLC

    Keith S. Lanier
    Ph: 503-215-6412

    Alaska Women's Cancer Care

    Keith S. Lanier
    Ph: 503-215-6412

    Anchorage Oncology Centre

    Keith S. Lanier
    Ph: 503-215-6412

    Katmai Oncology Group

    Keith S. Lanier
    Ph: 503-215-6412

    Providence Cancer Center

    Keith S. Lanier
    Ph: 503-215-6412

    Arizona
    Scottsdale

    Mayo Clinic Scottsdale

    John A Lust
    Ph: 507-538-7623

    California
    Burbank

    Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center

    Keith S. Lanier
    Ph: 503-215-6412

    Modesto

    Memorial Medical Center

    David A Shiba
    Ph: 415-209-2686
    Email: bernicl@sutterhealth.org

    Mountain View

    Palo Alto Medical Foundation

    David A Shiba
    Ph: 415-209-2686
    Email: bernicl@sutterhealth.org

    Orange

    Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

    Kanwarpal S Kahlon
    Ph: 877-827-8839
    Email: ucstudy@uci.edu

    Palo Alto

    Palo Alto Medical Foundation - Palo Alto

    Peter P. Yu
    Ph: 415-209-2686
    Email: bernicl@sutterhealth.org

    San Francisco

    UCSF Helen Diller Family Comprehensive Cancer Center

    Anuj K Mahindra
    Ph: 877-827-3222

    Santa Rosa

    Sutter Pacific Medical Foundation

    David A Shiba
    Ph: 415-209-2686
    Email: bernicl@sutterhealth.org

    Sunnyvale

    Palo Atlo Medical Foundation-Sunnyvale

    Peter P. Yu
    Ph: 415-209-2686
    Email: bernicl@sutterhealth.org

    Colorado
    Aurora

    Medical Center of Aurora - South Campus

    Keren Sturtz
    Ph: 888-785-6789

    Rocky Mountain Cancer Centers - Aurora

    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

    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

    Rocky Mountain Cancer Centers - Littleton

    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

    Thornton

    Rocky Mountain Cancer Centers - Thornton

    Keren Sturtz
    Ph: 888-785-6789

    Wheat Ridge

    Exempla Lutheran Medical Center

    Keren Sturtz
    Ph: 888-785-6789

    Connecticut
    Danbury

    Praxair Cancer Center at Danbury Hospital

    Vincent A Rella
    Ph: 203-739-8074

    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

    Norwich

    Eastern Connecticut Hematology and Oncology Associates

    Dennis E. Slater
    Ph: 860-886-8362

    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

    Neil Nagovski
    Ph: 888-823-5923
    Email: ctsucontact@westat.com

    Miami Beach

    CCOP - Mount Sinai Medical Center

    Michael Schwartz
    Ph: 305-674-2625
    Email: info@msccop.com

    Orlando

    Florida Hospital Cancer Institute at Florida Hospital Orlando

    Lee M. Zehngebot
    Ph: 407-303-5623

    Georgia
    Albany

    Phoebe Cancer Center at Phoebe Putney Memorial Hospital

    Jose M. Tongol
    Ph: 229-312-2251

    Atlanta

    Northside Hospital Cancer Center

    Thomas E. Seay
    Ph: 404-303-3355

    Winship Cancer Institute of Emory University

    Sagar Lonial
    Ph: 404-778-1868

    Augusta

    Medical College of Georgia Cancer Center

    Sharad Anant Ghamande
    Ph: 706-721-1663
    Email: cancer@georgiahealth.edu

    Decatur

    Charles B. Eberhart Cancer Center at DeKalb Medical Center

    Jayanthi Srinivasiah
    Ph: 404-501-3279

    Macon

    Medical Center of Central Georgia

    Frederick M. Schnell
    Ph: 404-501-3279

    Savannah

    Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler

    Mark A. Taylor
    Ph: 912-350-8568

    Idaho
    Boise

    Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center

    Christopher M Reynolds
    Ph: 734-712-4673

    Post Falls

    Kootenai Cancer Center - Post Falls

    Benjamin Thomas Marchello
    Ph: 800-648-6274

    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

    Creticos Cancer Center at Advocate Illinois Masonic Medical Center

    Denise Angelique Levitan
    Ph: 773-296-5360

    University of Illinois Cancer Center

    Pritesh Patel
    Ph: 312-355-3046

    Danville

    Carle on Vermilion

    James R Egner
    Ph: 800-446-5532

    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

    Carle Physician Group-Effingham

    James R Egner
    Ph: 800-446-5532

    Eureka

    Illinois CancerCare - Eureka

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

    Galesburg

    Medical and Surgical Specialists, LLC

    Nguyet A Le-Lindqwister
    Ph: 800-793-2262

    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

    Mattoon

    Carle Physician Group-Mattoon/Charleston

    James R Egner
    Ph: 800-446-5532

    Maywood

    Cardinal Bernardin Cancer Center at Loyola University Medical Center

    Kevin Barton
    Ph: 708-226-4357

    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

    Urbana

    Carle Cancer Center at Carle Foundation Hospital

    James R Egner
    Ph: 800-446-5532

    James R Egner
    Ph: 800-446-5532

    Indiana
    Lafayette

    Clarian Arnett Cancer Care

    Bamidele A Adesunloye
    Ph: 317-356-2422
    Email: thimes@iuhealth.org

    South Bend

    Memorial Hospital of South Bend

    Thomas Joseph Reid
    Ph: 800-284-7370

    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

    Richard L Deming
    Ph: 888-221-4849

    Mercy Cancer Center - West Lakes

    Richard L Deming
    Ph: 888-221-4849

    Des Moines

    Medical Oncology and Hematology Associates at Mercy Cancer Center

    Richard L Deming
    Ph: 888-221-4849

    Mercy Cancer Center at Mercy Medical Center - Des Moines

    Richard L Deming
    Ph: 888-221-4849

    Mason City

    Mercy Cancer Center at Mercy Medical Center - North Iowa

    Arvind Y Vemula
    Ph: 800-433-3883

    Sioux City

    Siouxland Hematology-Oncology Associates, LLP

    Donald Bruce Wender
    Ph: 712-252-0088

    West Des Moines

    Methodist West Hospital

    Richard L Deming
    Ph: 888-221-4849

    Kansas
    Great Bend

    St. Rose Ambulatory and Surgery Center

    Peter J. VanVeldhuizen
    Ph: 800-525-1483

    Kansas City

    Kansas City Cancer Centers - West

    Peter J. VanVeldhuizen
    Ph: 800-525-1483

    Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

    Peter J. VanVeldhuizen
    Ph: 800-525-1483

    Lawrence

    Lawrence Memorial Hospital

    Shaker R. Dakhil
    Ph: 316-262-4467

    Salina

    Tammy Walker Cancer Center at Salina Regional Health Center

    Peter J. VanVeldhuizen
    Ph: 800-525-1483

    Topeka

    Cotton-O'Neil Cancer Center

    David E Einspahr
    Ph: 785-270-4963

    Wichita

    Wesley Medical Center

    Shaker R. Dakhil
    Ph: 316-262-4467

    Kentucky
    Louisville

    Jewish Hospital

    Richard L Deming
    Ph: 888-221-4849

    Jewish Hospital Medical Center Northeast

    Richard L Deming
    Ph: 888-221-4849

    Louisiana
    Baton Rouge

    Ochsner Health Center - Bluebonnet

    Charles V Wendling
    Ph: 888-562-4763

    New Orleans

    Ochsner Cancer Institute at Ochsner Clinic Foundation

    Charles V Wendling
    Ph: 888-562-4763

    Tulane Cancer Center at Tulane University Hospital and Clinic

    Hana F Safah
    Ph: 504-988-6121

    Maryland
    Bethesda

    National Naval Medical Center

    David C Van Echo
    Ph: 301-319-2100

    Massachusetts
    Boston

    Tufts Medical Center Cancer Center

    Raymond L Comenzo
    Ph: 617-636-5000
    Email: ContactUsCancerCenter@TuftsMedicalCenter.org

    Worcester

    UMASS Memorial Cancer Center - University Campus

    Doreen B Brettler
    Ph: 508-856-3216
    Email: cancer.research@umassmed.edu

    Michigan
    Ann Arbor

    Saint Joseph Mercy Cancer Center

    Christopher M Reynolds
    Ph: 734-712-4673

    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

    Wayne State University

    Divaya Bhutani
    Ph: 313-576-9363

    Flint

    Genesys Hurley Cancer Institute

    Christopher M Reynolds
    Ph: 734-712-4673

    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

    Livonia

    St. Mary Mercy Hospital

    Christopher M Reynolds
    Ph: 734-712-4673

    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

    Saginaw

    Seton Cancer Institute at Saint Mary's - Saginaw

    Christopher M Reynolds
    Ph: 734-712-4673

    Southfield

    Providence Hospital - Southfield

    Howard R. Terebelo
    Ph: 248-849-5337
    Email: jaswinder.grewal@stjohn.org

    Warren

    St. John Macomb Hospital

    Christopher M Reynolds
    Ph: 734-712-4673

    Minnesota
    Burnsville

    Fairview Ridges Hospital

    Joseph W Leach
    Ph: 952-993-1517
    Email: MMCCOP@parknicollet.com

    Coon Rapids

    Mercy and Unity Cancer Center at Mercy Hospital

    Joseph W Leach
    Ph: 952-993-1517
    Email: MMCCOP@parknicollet.com

    Duluth

    CCOP - Duluth

    Bret E Friday
    Ph: 888-203-7267

    Edina

    Fairview Southdale Hospital

    Joseph W Leach
    Ph: 952-993-1517
    Email: MMCCOP@parknicollet.com

    Fergus Falls

    Lake Region Healthcare Corporation-Cancer Care

    Bret E Friday
    Ph: 888-203-7267

    Fridley

    Mercy and Unity Cancer Center at Unity Hospital

    Joseph W Leach
    Ph: 952-993-1517
    Email: MMCCOP@parknicollet.com

    Hutchinson

    Hutchinson Area Health Care

    Joseph W Leach
    Ph: 952-993-1517
    Email: MMCCOP@parknicollet.com

    Maplewood

    HealthEast Cancer Care at St. John's Hospital

    Joseph W Leach
    Ph: 952-993-1517
    Email: MMCCOP@parknicollet.com

    Minnesota Oncology - Maplewood

    Joseph W Leach
    Ph: 952-993-1517
    Email: MMCCOP@parknicollet.com

    Minneapolis

    Health Partners Inc

    Joseph W Leach
    Ph: 952-993-1517
    Email: MMCCOP@parknicollet.com

    Hennepin County Medical Center - Minneapolis

    Joseph W Leach
    Ph: 952-993-1517
    Email: MMCCOP@parknicollet.com

    Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

    Joseph W Leach
    Ph: 952-993-1517
    Email: MMCCOP@parknicollet.com

    Robbinsdale

    Humphrey Cancer Center at North Memorial Outpatient Center

    Joseph W Leach
    Ph: 952-993-1517
    Email: MMCCOP@parknicollet.com

    Rochester

    Mayo Clinic Cancer Center

    John A Lust
    Ph: 507-538-7623

    Saint Louis Park

    Park Nicollet Cancer Center

    Joseph W Leach
    Ph: 952-993-1517
    Email: MMCCOP@parknicollet.com

    Saint Paul

    Regions Hospital Cancer Care Center

    Joseph W Leach
    Ph: 952-993-1517
    Email: MMCCOP@parknicollet.com

    United Hospital

    Joseph W Leach
    Ph: 952-993-1517
    Email: MMCCOP@parknicollet.com

    Shakopee

    St. Francis Cancer Center at St. Francis Medical Center

    Joseph W Leach
    Ph: 952-993-1517
    Email: MMCCOP@parknicollet.com

    Waconia

    Ridgeview Medical Center

    Joseph W Leach
    Ph: 952-993-1517
    Email: MMCCOP@parknicollet.com

    Willmar

    Willmar Cancer Center at Rice Memorial Hospital

    Joseph W Leach
    Ph: 952-993-1517
    Email: MMCCOP@parknicollet.com

    Woodbury

    Minnesota Oncology - Woodbury

    Joseph W Leach
    Ph: 952-993-1517
    Email: MMCCOP@parknicollet.com

    Missouri
    Bolivar

    Central Care Cancer Center at Carrie J. Babb Cancer Center

    Jay W Carlson
    Ph: 800-821-7532

    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

    Jefferson City

    Goldschmidt Cancer Center

    Bryan A Faller
    Ph: 800-392-0936

    Kansas City

    Kansas City Cancer Centers - North

    Peter J. VanVeldhuizen
    Ph: 800-525-1483

    Kansas City Cancer Centers - South

    Peter J. VanVeldhuizen
    Ph: 800-525-1483

    Truman Medical Center - Hospital Hill

    Peter J. VanVeldhuizen
    Ph: 800-525-1483

    Veterans Affairs Medical Center - Kansas City

    Suman Kambhampati
    Ph: 800-525-1483

    Lee's Summit

    Kansas City Cancer Centers - East

    Peter J. VanVeldhuizen
    Ph: 800-525-1483

    Saint Louis

    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

    Missouri Baptist Cancer Center

    Bryan A Faller
    Ph: 800-392-0936

    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

    Richard L Deming
    Ph: 888-221-4849

    Kearney

    Good Samaritan Cancer Center at Good Samaritan Hospital

    Richard L Deming
    Ph: 888-221-4849

    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

    University Medical Center of Southern Nevada

    John Allan Ellerton
    Ph: 702-384-0013

    New Jersey
    Camden

    Cancer Institute of New Jersey at Cooper University Hospital - Camden

    Neil A Lachant
    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

    Ramakrishna Sudhindra
    Ph: 856-641-7933

    New Mexico
    Albuquerque

    Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital

    Dulcinea D Quintana
    Ph: 505-272-6972

    University of New Mexico Cancer Center

    Dulcinea D Quintana
    Ph: 505-272-6972

    New York
    Bronx

    Jack D. Weiler Hospital at Montefiore Medical Center - East Campus

    Ramakrishna Battini
    Ph: 718-904-2730
    Email: aecc@aecom.yu.edu

    Montefiore Medical Center

    Ramakrishna Battini
    Ph: 718-904-2730
    Email: aecc@aecom.yu.edu

    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

    Kinston

    Kinston Medical Specialists

    Peter R. Watson
    Ph: 252-559-2200

    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

    Rakhee Vaidya
    Ph: 336-713-6771

    North Dakota
    Bismarck

    Bismarck Cancer Center

    John T Reynolds
    Ph: 701-323-5760
    Email: tfischer@mohs.org

    Ohio
    Chardon

    Geauga Regional Hospital

    Hillard M. Lazarus
    Ph: 800-641-2422

    Cincinnati

    Good Samaritan Hospital Cancer Treatment Center

    Richard L Deming
    Ph: 888-221-4849

    TriHealth Cancer Institute-Anderson

    Richard L Deming
    Ph: 888-221-4849

    TriHealth Cancer Institute-Westside

    Richard L Deming
    Ph: 888-221-4849

    Cleveland

    Case Comprehensive Cancer Center

    Hillard M. Lazarus
    Ph: 800-641-2422

    MetroHealth Cancer Care Center at MetroHealth Medical Center

    Bruce J. Averbook
    Ph: 216-778-8526
    Email: kbauchens@metrohealth.org

    Columbus

    Columbus Oncology Associates, Incorporated

    J. Philip Kuebler
    Ph: 614-488-2745
    Email: sheree@columbusccop.org

    Mount Carmel Health - West Hospital

    J. Philip Kuebler
    Ph: 614-488-2745
    Email: sheree@columbusccop.org

    Riverside Methodist Hospital Cancer Care

    J. Philip Kuebler
    Ph: 614-488-2745
    Email: sheree@columbusccop.org

    Zangmeister Center

    J. Philip Kuebler
    Ph: 614-488-2745
    Email: sheree@columbusccop.org

    Lima

    St. Rita's Medical Center

    Henry Gerad
    Ph: 419-226-9617

    Marietta

    Strecker Cancer Center at Marietta Memorial Hospital

    J. Philip Kuebler
    Ph: 614-488-2745
    Email: sheree@columbusccop.org

    Mayfield Heights

    University Hospitals Ireland Cancer Center at Landerbrook Health Center

    Hillard M. Lazarus
    Ph: 800-641-2422

    Mentor

    Lake/University Ireland Cancer Center

    Hillard M. Lazarus
    Ph: 800-641-2422

    Newark

    Licking Memorial Cancer Care Program at Licking Memorial Hospital

    J. Philip Kuebler
    Ph: 614-488-2745
    Email: sheree@columbusccop.org

    Sandusky

    University Hospitals Ireland Cancer Center at Firelands Regional Medical Center

    Hillard M. Lazarus
    Ph: 800-641-2422

    Springfield

    Community Hospital of Springfield and Clark County

    J. Philip Kuebler
    Ph: 614-488-2745
    Email: sheree@columbusccop.org

    Westerville

    Mount Carmel St. Ann's Cancer Center

    J. Philip Kuebler
    Ph: 614-488-2745
    Email: sheree@columbusccop.org

    Westlake

    UHHS Westlake Medical Center

    Hillard M. Lazarus
    Ph: 800-641-2422

    UH-Seidman Cancer Center at Saint John Medical Center

    Hillard M. Lazarus
    Ph: 800-641-2422

    Oregon
    Newberg

    Providence Newberg Medical Center

    Keith S. Lanier
    Ph: 503-215-6412

    Oregon City

    Willamette Falls Hospital

    Keith S. Lanier
    Ph: 503-215-6412

    Portland

    Providence Cancer Center at Providence Portland Medical Center

    Keith S. Lanier
    Ph: 503-215-6412

    Providence St. Vincent Medical Center

    Keith S. Lanier
    Ph: 503-215-6412

    Pennsylvania
    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

    Giampaolo Talamo
    Ph: 717-531-3779
    Email: CTO@hmc.psu.edu

    Pittsburgh

    Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital

    Entezam A Sahovic
    Ph: 412-578-1034

    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

    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

    South Carolina
    Charleston

    Charleston Hematology Oncology Associates PA-St. Francis

    James Michael Orcutt
    Ph: 843-720-8386
    Email: elizabeth.strojny@roperstfrancis.com

    Charleston Hematology Oncology Associates, PA

    James Michael Orcutt
    Ph: 843-720-8386
    Email: elizabeth.strojny@roperstfrancis.com

    Roper St. Francis Cancer Center at Roper Hospital

    James Michael Orcutt
    Ph: 843-720-8386
    Email: elizabeth.strojny@roperstfrancis.com

    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

    Mount Pleasant

    Lowcountry Hematology and Oncology, PA

    James Michael Orcutt
    Ph: 843-720-8386
    Email: elizabeth.strojny@roperstfrancis.com

    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

    Tennessee
    Jackson

    West Tennessee Cancer Center at Jackson-Madison County General Hospital

    Dwight C Kaufman
    Ph: 731-425-6865

    Texas
    Dallas

    Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

    Larry D Anderson
    Ph: 214-648-7097

    Lubbock

    Covenant Medical Center

    Donald P Quick
    Ph: 806-725-8000
    Email: jaccresearch@covhs.org

    Vermont
    Rutland

    Community Cancer Center at Rutland Regional Medical Center

    Allan D. Eisemann
    Ph: 802-775-7111

    Virginia
    Danville

    Danville Regional Medical Center

    Qiwei W Gai
    Ph: 434-793-0044

    Washington
    Longview

    Lower Columbia Regional Cancer Center at PeaceHealth-St. John Medical Center

    Keith S. Lanier
    Ph: 503-215-6412

    Puyallup

    Good Samaritan Cancer Center

    John A Keech
    Ph: 907-458-5380

    Tacoma

    MultiCare Regional Cancer Center at Tacoma General Hospital

    John A Keech
    Ph: 907-458-5380

    Vancouver

    Southwest Washington Medical Center Cancer Center

    Keith S. Lanier
    Ph: 503-215-6412

    West Virginia
    Charleston

    West Virginia University Medical School - Charleston

    Steven J. Jubelirer
    Ph: 304-344-3457

    Wisconsin
    Burlington

    Aurora Cancer Care-Burlington

    Dhimant R. Patel
    Ph: 800-252-2990

    Chippewa Falls

    Marshfield Clinic - Chippewa Center

    Douglas J Reding
    Ph: 715-389-4457

    Eau Claire

    Marshfield Clinic Cancer Care at Regional Cancer Center

    Douglas J Reding
    Ph: 715-389-4457

    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

    Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center

    Dhimant R. Patel
    Ph: 800-252-2990

    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

    Marinette

    Vince Lombardi Cancer Clinic - Marinette

    Dhimant R. Patel
    Ph: 800-252-2990

    Marshfield

    Marshfield Clinic - Marshfield Center

    Douglas J Reding
    Ph: 715-389-4457

    Menomonee Falls

    Aurora Advanced Healthcare Inc-Menomonee Falls

    Dhimant R. Patel
    Ph: 800-252-2990

    Mequon

    Columbia Saint Mary's Hospital - Ozaukee

    Charles H. I. Tiber
    Ph: 414-326-2675
    Email: clinicaltrials@columbia-stmarys.org

    Milwaukee

    Aurora Cancer Care-Milwaukee

    Dhimant R. Patel
    Ph: 800-252-2990

    Aurora Sinai Medical Center

    Dhimant R. Patel
    Ph: 800-252-2990

    Columbia-Saint Mary's Cancer Care Center

    Charles H. I. Tiber
    Ph: 414-326-2675
    Email: clinicaltrials@columbia-stmarys.org

    Oncology Alliance, SC - Milwaukee - South

    Dhimant R. Patel
    Ph: 800-252-2990

    Minocqua

    Marshfield Clinic - Lakeland Center

    Douglas J Reding
    Ph: 715-389-4457

    Oconomowoc

    Regional Cancer Center at Oconomowoc Memorial Hospital

    Timothy R Wassenaar
    Ph: 262-928-7878

    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

    Douglas J Reding
    Ph: 715-389-4457

    Rice Lake

    Marshfield Clinic - Indianhead Center

    Douglas J Reding
    Ph: 715-389-4457

    Sheboygan

    Vince Lombardi Cancer Clinic - Sheboygan

    Dhimant R. Patel
    Ph: 800-252-2990

    Stevens Point

    Marshfield Clinic at Saint Michael's Hospital

    Douglas J Reding
    Ph: 715-389-4457

    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

    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

    Diagnostic and Treatment Center

    Douglas J Reding
    Ph: 715-389-4457

    Marshfield Clinic - Weston Center

    Douglas J Reding
    Ph: 715-389-4457

    Wisconsin Rapids

    Marshfield Clinic - Wisconsin Rapids Center

    Douglas J Reding
    Ph: 715-389-4457

    Ireland

    Co Dublin
    Dublin

    Mater Misericordiae University Hospital

    Peter O'Gorman
    Ph: 353 1 8032000

    Mater Private Hospital

    Peter O'Gorman
    Ph: 353 1 8032000

    Co Galway
    Galway

    University College Hospital

    Michael E O'Dwyer
    Ph: 353 1 8287100
    Email: info@cancercontrol.ie

    Link to the current ClinicalTrials.gov record.
    NLM Identifier NCT01169337
    ClinicalTrials.gov processed this data on May 21, 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.