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Clinical Trials (PDQ®)

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

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

Basic Trial Information

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

Trial Sites

U.S.A.
Arizona
  Scottsdale
 Mayo Clinic Scottsdale
 John A Lust Ph: 507-538-7623
California
  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
 David S Leibowitz 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
 Ari D Baron Ph: 415-600-1182
  Email: SchmidtJ@cpmcri.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
  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
 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
  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
  Danbury
 Praxair Cancer Center at Danbury Hospital
 Marc G Rappaport 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
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
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Canton
 Illinois CancerCare - Canton
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Carthage
 Illinois CancerCare - Carthage
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Chicago
 Creticos Cancer Center at Advocate Illinois Masonic Medical Center
 Denise Angelique Levitan Ph: 336-713-6771
  Decatur
 Decatur Memorial Hospital Cancer Care Institute
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Eureka
 Illinois CancerCare - Eureka
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Galesburg
 Medical and Surgical Specialists, LLC
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Kewanee
 Illinois CancerCare - Kewanee Clinic
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Macomb
 Illinois CancerCare - Macomb
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Ottawa
 Illinois CancerCare - Ottawa
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Pekin
 Illinois CancerCare - Pekin
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Peoria
 Illinois CancerCare - Peoria
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Peru
 Illinois CancerCare - Princeton
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Princeton
 Illinois CancerCare - Princeton
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Rockford
 Advanced Care and Treatment Medical Group, PC
 Harvey Eric Einhorn Ph: 779-696-9400
  Email: cancercare@swedishamerican.org
  Springfield
 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
Indiana
  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
  Clive
 Medical Oncology and Hematology Associates-West Des Moines
 Richard L Deming Ph: 888-221-4849
  Email: sherrijr@iora.org
  Des Moines
 Medical Oncology and Hematology Associates at Mercy Cancer Center
 Richard L Deming Ph: 888-221-4849
  Email: sherrijr@iora.org
  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
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
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
Massachusetts
  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
  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
  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
  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
  Southfield
 Providence Hospital - Southfield
 Anibal Drelichman 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
 Daniel Nikcevich 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
 Daniel Nikcevich 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
 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
  Stillwater
 Lakeview Hospital
 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
Mississippi
  Jackson
 University of Mississippi Cancer Clinic
 Stephanie L Elkins Ph: 601-815-6700
Missouri
  Bolivar
 Central Care Cancer Center at Carrie J. Babb Cancer Center
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
  Cape Girardeau
 Saint Francis Medical Center
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  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
  Email: sherrijr@iora.org
 Mercy Clinic St. Louis Cancer and Breast Institute
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
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
 Richard L Deming Ph: 888-221-4849
  Email: sherrijr@iora.org
  Kearney
 Good Samaritan Cancer Center at Good Samaritan Hospital
 Richard L Deming Ph: 888-221-4849
  Email: sherrijr@iora.org
  Lincoln
 Cancer Resource Center - Lincoln
 Gamini S. Soori Ph: 402-280-4100
  Omaha
 Fred and Pamela Buffett Cancer Center
 Richard L Deming Ph: 888-221-4849
  Email: sherrijr@iora.org
Nevada
  Las Vegas
 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
  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
 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
 Stefan K Barta Ph: 215-728-4790
  Email: aecc@aecom.yu.edu
 Montefiore Medical Center
 Stefan K Barta Ph: 215-728-4790
  Email: aecc@aecom.yu.edu
North Carolina
  Kinston
 Kinston Medical Specialists
 Peter R. Watson Ph: 252-559-2200
  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
  Cleveland
 Case Comprehensive Cancer Center
 Erica L Campagnaro 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: 614-566-3275
 Mount Carmel Health - West Hospital
 J. Philip Kuebler Ph: 800-446-5532
 Riverside Methodist Hospital Cancer Care
 J. Philip Kuebler Ph: 800-446-5532
 Zangmeister Center
 J. Philip Kuebler Ph: 800-446-5532
  Lima
 St. Rita's Medical Center
 Henry Gerad Ph: 419-226-9617
  Marietta
 Strecker Cancer Center at Marietta Memorial Hospital
 J. Philip Kuebler Ph: 800-446-5532
  Newark
 Licking Memorial Cancer Care Program at Licking Memorial Hospital
 J. Philip Kuebler Ph: 800-446-5532
  Springfield
 Community Hospital of Springfield and Clark County
 J. Philip Kuebler Ph: 614-566-3275
  Westerville
 Mount Carmel St. Ann's Cancer Center
 J. Philip Kuebler Ph: 800-446-5532
Oregon
  Newberg
 Providence Newberg Medical Center
 Alison K Conlin Ph: 503-215-6412
  Oregon City
 Willamette Falls Hospital
 Alison K Conlin Ph: 503-215-6412
  Portland
 Providence Cancer Center at Providence Portland Medical Center
 Alison K Conlin Ph: 503-215-6412
 Providence St. Vincent Medical Center
 Alison K Conlin Ph: 503-215-6412
Pennsylvania
  Bryn Mawr
 Bryn Mawr Hospital
 Paul B. Gilman Ph: 484-476-2649
  Email: wellenbachj@mlhs.org
  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
  Paoli
 Cancer Center of Paoli Memorial Hospital
 Paul B. Gilman Ph: 484-476-2649
  Email: wellenbachj@mlhs.org
  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
 Philip A. Lowry 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
 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
  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
 Mark T Schroeder 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
  Knoxville
 U.T. Medical Center Cancer Institute
 Wahid T. Hanna Ph: 865-544-9773
Texas
  Dallas
 Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
 Larry D Anderson Ph: 214-648-7097
Washington
  Puyallup
 Good Samaritan Cancer Center
 Yoshio Inoue Ph: 253-403-2394
  Tacoma
 MultiCare Regional Cancer Center at Tacoma General Hospital
 Yoshio Inoue Ph: 253-403-2394
  Vancouver
 Southwest Washington Medical Center Cancer Center
 Alison K Conlin Ph: 503-215-6412
West Virginia
  Charleston
 West Virginia University Medical School - Charleston
 Steven J. Jubelirer Ph: 304-344-3457
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
  Madison
 Dean Hematology & Oncology Clinic
 Amit Sanyal Ph: 608-410-2700
  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
 Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
 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 Identifer NCT01169337
ClinicalTrials.gov processed this data on November 18, 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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