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Clinical Trials (PDQ®)

S1211, Bortezomib, Dexamethasone, and Lenalidomide With or Without Elotuzumab in Treating Patients With Newly Diagnosed High-Risk Multiple Myeloma

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase II, Phase ITreatmentActive18 and overNCI, OtherCDR0000738512
S1211, U10CA032102, nci-2012-01998, SWOG-S1211, NCT01668719

Trial Description

Summary

RATIONALE: Lenalidomide and bortezomib may stop the growth of multiple myeloma by blocking blood flow to the tumor. Also, bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as elotuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as lenalidomide and dexamethasone also work in different ways to kill tumor cells or stop them from growing. Giving elotuzumab together with chemotherapy may be a better way to block cancer growth.

PURPOSE: This phase I/II trial is studying the side effects and best dose of elotuzumab and to see how well it works when given with lenalidomide, bortezomib, and dexamethasone in treating patients with multiple myeloma.

Further Study Information

OBJECTIVES:

  • To determine the appropriate Phase II dose of elotuzumab to use in combination with lenalidomide, bortezomib, and dexamethasone for patients with multiple myeloma. (Phase I)
  • To assess whether incorporation of the novel agent elotuzumab into the treatment algorithm of high-risk multiple myeloma (HRMM) will improve progression-free survival (PFS). (Phase II)
  • To estimate the frequency and severity of toxicities of this treatment strategy in this patient population.

OUTLINE: This is a multicenter, phase I, dose-escalation study of elotuzumab, followed by a phase II, randomized study. Patients are stratified according to primary plasma cell leukemia and/or high lactic dehydrogenase (LDH) vs everyone else.

Phase I:

  • Induction: Patients receive bortezomib subcutaneously (SC) or IV on days 1, 4, 8, and 11; lenalidomide orally (PO) once daily on days 1-14; and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Patients also receive elotuzumab IV on days 1, 8, and 15 of courses 1 and 2 and on days 1 and 11 of courses 3-8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
  • Maintenance: Patients receive bortezomib SC or IV on days 1, 8, and 15; lenalidomide PO once daily on days 1-21; dexamethasone PO on days 1, 8, and 15; and elotuzumab IV on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Phase II: Patients are randomized to 1 of 2 treatment arms.

  • Arm I:
  • Induction: Patients receive bortezomib SC or IV on days 1, 4, 8, and 11; lenalidomide PO once daily on days 1-14; and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity (patients who received a course of chemotherapy prior to registration will begin protocol treatment with course 2 and receive a total of 7 courses of protocol therapy).
  • Maintenance: Patients receive bortezomib SC or IV on days 1, 8, and 15; lenalidomide PO once daily on days 1-21; and dexamethasone PO on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
  • Arm II:
  • Induction: Patients receive bortezomib, lenalidomide, and dexamethasone as in arm I. Patients also receive elotuzumab IV on days 1, 8, and 15 of courses 1 and 2 and on days 1 and 11 of courses 3-8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
  • Maintenance: Patients receive bortezomib, lenalidomide, and dexamethasone as in arm I. Patients also receive elotuzumab IV on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 3 months for up to 6 years.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Patients must have newly diagnosed active multiple myeloma (MM)
  • Patients with non-secretory MM or known amyloidosis are not eligible
  • For the Phase II portion only, patients must have high-risk MM based on one or more of the following criteria at the time of initial diagnosis (prior to any chemotherapy):
  • Poor-risk genomic signature according to the University of Arkansas 70-gene model (available clinically as MyPRS score, Signal Genetics, Inc.)
  • Translocation (14;16), and/or translocation (14;20), and/or deletion (17p) by florescence in-situ hybridization (FISH) or cytogenetics
  • Primary plasma cell leukemia (defined by either ≥ 2,000 plasma cells/mL of peripheral blood, or 20% on a manual differential count
  • Serum lactate dehydrogenase (LDH) ≥ 2 times institutional upper limit of normal (IULN)
  • Patients must have measurable disease within 28 days prior to registration (or prior to initiation of first induction course for patients with prior therapy)
  • Patients on the Phase I portion may not have received ANY prior chemotherapy
  • Patients on the Phase II portion may have received one prior cycle of any noninvestigational chemotherapy
  • Patients must not have active involvement of the central nervous system (CNS) with MM (by clinical evaluation)
  • Patients with documentation of or clinical signs or symptoms consistent with CNS involvement by MM must have a lumbar puncture that is negative for CNS involvement
  • Patients with no previous history of documented CNS involvement and with no clinical signs or symptoms consistent with CNS involvement are not required to have completed a lumbar puncture prior to registration

PATIENT CHARACTERISTICS:

  • Zubrod performance status ≤ 2
  • Absolute neutrophil count (ANC) ≥ 1,000 cells/mm³ without growth factor support
  • Platelet count ≥ 70,000 cells/mm³ for patients who have bone marrow plasmacytosis < 50% OR ≥ 50,000 cells/mm³ for patients who have bone marrow plasmacytosis of ≥ 50%
  • Total bilirubin ≤ 1.5 times institutional upper limit of normal (IULN)
  • Serum glutamic oxalo-acetic transaminase (SGOT)/aspartate aminotransferase (AST) and serum glutamic pyruvate transaminase (SGPT)/alanine aminotransferase (ALT) ≤ 2.5 times IULN
  • Creatinine clearance (CrCL) ≥ 30 mL/min
  • Patients who are known to be human immunodeficiency virus (HIV)-positive are eligible providing they meet all of the following additional criteria within 28 days prior to registration:
  • CD4 cells ≥ 500/mm³
  • Viral load of < 50 copies HIV mRNA/mm³ if on antiretroviral therapy (ART) or < 25,000 copies HIV mRNA if not on ART
  • No zidovudine or stavudine as part of ART
  • Patients must have baseline skeletal survey to document lytic lesions, osteopenia, or compression fracture
  • Patients with known hepatitis B or hepatitis C infection may be eligible providing they have viral load < 800,000 IU/L within 28 days prior to registration
  • Patients must not have POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
  • Patients must not have clinically significant illness including any of the following:
  • Uncontrolled, active infection requiring intravenous antibiotics
  • New York Heart Association (NYHA) Class III or Class IV heart failure
  • Unstable angina pectoris
  • Myocardial infarction within the past 6 months
  • ≥ Grade 3 cardiac arrhythmias per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
  • Patients must have undergone an electrocardiogram (EKG) within 28 days prior to registration
  • Uncontrolled blood pressure (BP) or hypertension
  • Defined as systolic BP > 140 mm Hg or diastolic BP > 90 mm Hg within 14 days prior to registration
  • An exception can be made by a healthcare provider for a patient with a single BP elevation who, upon rechecking, has a normal BP
  • Patients are permitted to be receiving multiple antihypertensive medications (unless otherwise indicated in the study)
  • Uncontrolled diabetes mellitus (defined as a glycosylated hemoglobin A1C (Hg A1C) > 7% within 14 days prior to registration)
  • The same criterion will be used in patients with confirmed diagnosis of diabetes mellitus who have been on a stable dietary or therapeutic regimen for this condition in the last three months
  • Patients must not have any psychiatric illness that could potentially interfere with the completion of treatment according to this protocol
  • 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 registration
  • 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 and continuing for at least 4 months after completion of study therapy
  • Men must agree to use a latex condom during sexual contact with a FCBP, even if they have had a successful vasectomy
  • Not pregnant or breastfeeding
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Prior chemotherapy must have been completed within 56 days prior to registration and all toxicities must have resolved to ≤ Grade 1
  • Patients may have received prior radiotherapy for symptomatic localized bone lesions or impending spinal cord compression only
  • Radiotherapy must be completed at least 14 days prior to registration and all toxicities must have resolved to ≤ Grade 1

Trial Contact Information

Trial Lead Organizations/Sponsors

Southwest Oncology Group

National Cancer Institute

Bristol-Myers Squibb Company - New York

Saad Z. UsmaniPrincipal Investigator

Sandi J FredettePh: 2106148808 Ext.1002
  Email: sfredette@swog.org

Trial Sites

U.S.A.
Arizona
  Tucson
 Arizona Cancer Center at University Medical Center North
 Faiz Anwer Ph: 520-626-9008
 Arizona Cancer Center at University of Arizona Health Sciences Center
 Faiz Anwer Ph: 520-626-9008
California
  Duarte
 City of Hope Comprehensive Cancer Center
 Michael A Rosenzweig Ph: 800-826-4673
  Email: becomingapatient@coh.org
  Los Angeles
 USC/Norris Comprehensive Cancer Center and Hospital
 Sikander Ailawadhi Ph: 323-865-0451
 Sikander Ailawadhi Ph: 323-865-0451
  Marysville
 Fremont-Rideout Cancer Center
 Joseph M. Tuscano Ph: 916-734-3089
  Sacramento
 University of California Davis Cancer Center
 Joseph M. Tuscano Ph: 916-734-3089
Connecticut
  Hartford
 Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
 Christopher M Reynolds Ph: 734-712-4673
  New Britain
 George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
 Brian J Byrne Ph: 860-224-5660
Delaware
  Lewes
 Tunnell Cancer Center at Beebe Medical Center
 Stephen Scott Grubbs Ph: 302-733-6227
  Newark
 Christiana Gynecologic Oncology, LLC
 Stephen Scott Grubbs Ph: 302-733-6227
 Delaware Clinical and Laboratory Physicians
 Stephen Scott Grubbs Ph: 302-733-6227
 Helen F. Graham Cancer Center at Christiana Hospital
 Stephen Scott Grubbs Ph: 302-733-6227
 Stephen Scott Grubbs Ph: 302-733-6227
 Medical Oncology Hematology Consultants, PA at Helen F. Graham Cancer Center
 Stephen Scott Grubbs Ph: 302-733-6227
 Regional Hematology/Oncology, PA - Newark
 Stephen Scott Grubbs Ph: 302-733-6227
  Rehoboth Beach
 Beebe Health Campus
 Stephen Scott Grubbs Ph: 302-733-6227
  Seaford
 Nanticoke Memorial Hospital
 Stephen Scott Grubbs Ph: 302-733-6227
  Wilmington
 Christiana Care Health System-Wilmington Hospital
 Stephen Scott Grubbs Ph: 302-733-6227
Florida
  Jacksonville
 Mayo Clinic - Jacksonville
 Ronald S Go Ph: 507-538-7623
  Email: cancerctr@gundluth.org
Hawaii
  Aiea
 Kapiolani Medical Center at Pali Momi
 Jeffrey L. Berenberg Ph: 808-586-2979
 Jeffrey L. Berenberg Ph: 808-586-2979
  Honolulu
 Cancer Research Center of Hawaii
 Jeffrey L. Berenberg Ph: 808-586-2979
 Kapiolani Medical Center for Women and Children
 Jeffrey L. Berenberg Ph: 808-586-2979
 OnCare Hawaii, Incorporated - Kuakini
 Jeffrey L. Berenberg Ph: 808-586-2979
 Jeffrey L. Berenberg Ph: 808-586-2979
 OnCare Hawaii, Incorporated - Lusitana
 Jeffrey L. Berenberg Ph: 808-586-2979
 Queen's Cancer Institute at Queen's Medical Center
 Jeffrey L. Berenberg Ph: 808-586-2979
 Straub Clinic and Hospital, Incorporated
 Jeffrey L. Berenberg Ph: 808-586-2979
  Kailua
 Castle Medical Center
 Jeffrey L. Berenberg Ph: 808-586-2979
  Lihue
 Kauai Medical Clinic
 Jeffrey L. Berenberg Ph: 808-586-2979
Idaho
  Boise
 Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
 Christopher M Reynolds Ph: 734-712-4673
Illinois
  Carbondale
 Memorial Hospital of Carbondale
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Centralia
 Centralia Oncology Clinic
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Decatur
 Cancer Care Center of Decatur
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
 Decatur Memorial Hospital Cancer Care Institute
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Effingham
 Crossroads Cancer Center
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Harvey
 Ingalls Cancer Care Center at Ingalls Memorial Hospital
 Mark F. Kozloff Ph: 708-915-4673
  Email: clinicaltrials@ingalls.org
  Maywood
 Cardinal Bernardin Cancer Center at Loyola University Medical Center
 Kevin Barton Ph: 708-226-4357
  Moline
 Garneau, Stewart C MD (UIA Investigator)
 David M Spector Ph: 309-779-4200
 Porubcin, Michael MD (UIA Investigator)
 David M Spector Ph: 309-779-4200
 Spector, David MD (UIA Investigator)
 David M Spector Ph: 309-779-4200
 Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
 David M Spector Ph: 309-779-4200
  Mount Vernon
 Good Samaritan Regional Health Center
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
  Springfield
 Regional Cancer Center at Memorial Medical Center
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
Iowa
  Ames
 McFarland Clinic, PC
 Joseph James Merchant Ph: 515-239-2621
 William R. Bliss Cancer Center at Mary Greeley Medical Center
 Joseph James Merchant Ph: 515-239-2621
  Bettendorf
 Constantinou, Costas L MD (UIA Investigator)
 David M Spector Ph: 309-779-4200
  Boone
 McFarland Clinic PC-Boone
 Joseph James Merchant Ph: 515-239-2621
  Jefferson
 McFarland Clinic PC-Jefferson
 Joseph James Merchant Ph: 515-239-2621
  Marshalltown
 McFarland Clinic PC-Marshalltown
 Joseph James Merchant Ph: 515-239-2621
  Sioux City
 Mercy Medical Center - Sioux City
 Donald Bruce Wender Ph: 712-252-0088
 Siouxland Hematology-Oncology Associates, LLP
 Donald Bruce Wender Ph: 712-252-0088
 St. Luke's Regional Medical Center
 Donald Bruce Wender Ph: 712-252-0088
Kansas
  Emporia
 Newman Regional Health
 Peter J. VanVeldhuizen Ph: 800-525-1483
  Garden City
 St. Catherine Hospital Cancer Center
 Peter J. VanVeldhuizen Ph: 800-525-1483
  Great Bend
 St. Rose Ambulatory and Surgery Center
 Peter J. VanVeldhuizen Ph: 800-525-1483
  Hays
 Hays Medical 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
  Overland Park
 Kansas City Cancer Centers - Southwest
 Peter J. VanVeldhuizen Ph: 800-525-1483
 Menorah Medical Center
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
 Saint Luke's Hospital - South
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
  Pittsburg
 Mount Carmel Regional Cancer Center
 Peter J. VanVeldhuizen Ph: 800-525-1483
  Prairie Village
 CCOP - Kansas City
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
  Salina
 Tammy Walker Cancer Center at Salina Regional Health Center
 Peter J. VanVeldhuizen Ph: 800-525-1483
  Topeka
 St. Francis Comprehensive Cancer Center
 Peter J. VanVeldhuizen Ph: 800-525-1483
  Wichita
 Wesley Medical Center
 Shaker R. Dakhil Ph: 316-262-4467
Louisiana
  Baton Rouge
 Hematology-Oncology Clinic
 Hana F Safah Ph: 504-988-6121
  New Orleans
 Tulane Cancer Center at Tulane University Hospital and Clinic
 Hana F Safah Ph: 504-988-6121
Maryland
  Baltimore
 Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
 Roberto F Martinez Ph: 410-601-6120
  Email: pridgely@lifebridgehealth.org
Michigan
  Adrian
 Hickman Cancer Center at Bixby Medical Center
 Rex B Mowat Ph: 517-265-0116
 Rex B Mowat Ph: 517-265-0116
  Ann Arbor
 CCOP - Michigan Cancer Research Consortium
 Christopher M Reynolds Ph: 734-712-4673
 Saint Joseph Mercy Cancer Center
 Christopher M Reynolds Ph: 734-712-4673
  Battle Creek
 Battle Creek Health System Cancer Care Center
 Gilbert D Padula Ph: 616-685-5225
  Dearborn
 Oakwood Cancer Center at Oakwood Hospital and Medical Center
 Christopher M Reynolds Ph: 734-712-4673
  Detroit
 Barbara Ann Karmanos Cancer Institute
 Jeffrey A. Zonder
  Email: zonderj@karmanos.org
 Van Elslander Cancer Center at St. John Hospital and Medical Center
 Christopher M Reynolds Ph: 734-712-4673
 Wayne State University
 Jeffrey A. Zonder Ph: 313-576-9363
  Escanaba
 Green Bay Oncology, Limited - Escanaba
 Matthew L Ryan Ph: 800-432-6049
  Flint
 Genesys Hurley Cancer Institute
 Christopher M Reynolds Ph: 734-712-4673
 Hurley Medical Center
 Christopher M Reynolds Ph: 734-712-4673
  Grand Rapids
 Butterworth Hospital at Spectrum Health
 Gilbert D Padula Ph: 616-685-5225
 CCOP - Grand Rapids
 Gilbert D Padula Ph: 616-685-5225
  Iron Mountain
 Green Bay Oncology - Iron Mountain
 Matthew L Ryan Ph: 800-432-6049
  Jackson
 Gayle M. Jacob Cancer Center at Allegiance Health
 Christopher M Reynolds Ph: 734-712-4673
  Lansing
 Sparrow Regional Cancer Center
 Christopher M Reynolds Ph: 734-712-4673
  Livonia
 St. Mary Mercy Hospital
 Christopher M Reynolds Ph: 734-712-4673
  Monroe
 Community Cancer Center of Monroe
 Rex B Mowat Ph: 517-265-0116
 Mercy Memorial Hospital - Monroe
 Rex B Mowat Ph: 517-265-0116
  Pontiac
 St. Joseph Mercy Oakland
 Christopher M Reynolds Ph: 734-712-4673
  Port Huron
 Mercy Regional Cancer Center at Mercy Hospital
 Christopher M Reynolds Ph: 734-712-4673
  Reed City
 Spectrum Health Reed City Hospital
 Gilbert D Padula Ph: 616-685-5225
  Saginaw
 Seton Cancer Institute at Saint Mary's - Saginaw
 Christopher M Reynolds Ph: 734-712-4673
  Southfield
 Providence Hospital - Southfield
 Andrew A Muskovitz Ph: 248-849-5337
  Email: jaswinder.grewal@stjohn.org
  Traverse City
 Munson Medical Center
 Gilbert D Padula Ph: 616-685-5225
  Warren
 St. John Macomb Hospital
 Christopher M Reynolds Ph: 734-712-4673
Minnesota
  Bemidji
 MeritCare Bemidji
 Preston D. Steen Ph: 701-234-6161
  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
 Essentia Health - Duluth Clinic
 Bret E Friday Ph: 888-203-7267
 Miller - Dwan Medical Center
 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
 Hennepin County Medical Center - Minneapolis
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  New Ulm
 New Ulm Medical Center
 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
 Ronald S Go Ph: 507-538-7623
  Email: cancerctr@gundluth.org
  Saint Louis Park
 CCOP - Metro-Minnesota
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Park Nicollet Cancer Center
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Saint Paul
 Regions Hospital Cancer Care Center
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 United Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Shakopee
 St. Francis Cancer Center at St. Francis Medical Center
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Stillwater
 Lakeview Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Waconia
 Ridgeview Medical Center
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Willmar
 Willmar Cancer Center at Rice Memorial Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Woodbury
 Minnesota Oncology - Woodbury
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
Mississippi
  Jackson
 University of Mississippi Cancer Clinic
 Tondre T Buck 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
  Branson
 Skaggs Cancer Center at Skaggs Regional Medical 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
  Independence
 Independence Regional Health Center
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
  Kansas City
 Heartland Hematology Oncology Associates, Incorporated
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
 Kansas City Cancer Centers - North
 Peter J. VanVeldhuizen Ph: 800-525-1483
 Kansas City Cancer Centers - South
 Peter J. VanVeldhuizen Ph: 800-525-1483
 Research Medical Center
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
 Saint Luke's Hospital
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
 Truman Medical Center - Hospital Hill
 Peter J. VanVeldhuizen Ph: 800-525-1483
  Lee's Summit
 Kansas City Cancer Centers - East
 Peter J. VanVeldhuizen Ph: 800-525-1483
 Saint Luke's East - Lee's Summit
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
  Liberty
 Parvin Radiation Oncology
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
  Rolla
 Mercy Clinic Cancer and Hematology - Rolla
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
 Phelps County Regional Medical Center
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
  Saint Joseph
 Heartland Regional Medical Center
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
  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
  Springfield
 Cancer Research for the Ozarks
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
 Hulston Cancer Center at Cox Medical Center South
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
 St. John's Regional Health Center
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
Nebraska
  Lincoln
 Cancer Resource Center - Lincoln
 Gamini S. Soori Ph: 800-253-4368
  Omaha
 Alegant Health Cancer Center at Bergan Mercy Medical Center
 Gamini S. Soori Ph: 800-253-4368
 CCOP - Missouri Valley Cancer Consortium
 Gamini S. Soori Ph: 800-253-4368
 Creighton University Medical Center
 Gamini S. Soori Ph: 800-253-4368
 Immanuel Medical Center
 Gamini S. Soori Ph: 800-253-4368
 Lakeside Hospital
 Gamini S. Soori Ph: 800-253-4368
Nevada
  Henderson
 21st Century Oncology - Henderson
 John Allan Ellerton Ph: 702-384-0013
 Cancer and Blood Specialists-Henderson
 John Allan Ellerton Ph: 702-384-0013
 Comprehensive Cancer Centers of Nevada - Henderson
 John Allan Ellerton Ph: 702-384-0013
 Comprehensive Cancer Centers of Nevada-Southeast Henderson
 John Allan Ellerton Ph: 702-384-0013
 Las Vegas Cancer Center - Henderson
 John Allan Ellerton Ph: 702-384-0013
  Las Vegas
 21st Century Oncology - Fort Apache
 John Allan Ellerton Ph: 702-384-0013
 21st Century Oncology - Vegas Sunrise
 John Allan Ellerton Ph: 702-384-0013
 21st Century Oncology - Vegas Tenaya
 John Allan Ellerton Ph: 702-384-0013
 Cancer and Blood Specialists-Fort Apache
 John Allan Ellerton Ph: 702-384-0013
 Cancer and Blood Specialists-Shadow
 John Allan Ellerton Ph: 702-384-0013
 Cancer and Blood Specialists-Tenaya
 John Allan Ellerton Ph: 702-384-0013
 Cancer Institute of Nevada at Summerlin Hospital Medical Center
 John Allan Ellerton Ph: 702-384-0013
 Cancer Therapy and Integrative Medicine
 John Allan Ellerton Ph: 702-384-0013
 CCOP - Nevada Cancer Research Foundation
 John Allan Ellerton Ph: 702-384-0013
 Comprehensive Cancer Centers of Nevada - Central Valley
 John Allan Ellerton Ph: 702-384-0013
 Comprehensive Cancer Centers of Nevada - Northwest
 John Allan Ellerton Ph: 702-384-0013
 Comprehensive Cancer Centers of Nevada - Southwest
 John Allan Ellerton Ph: 702-384-0013
 HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
 John Allan Ellerton Ph: 702-384-0013
 HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
 John Allan Ellerton Ph: 702-384-0013
 HealthCare Partners Medical Group Oncology/Hematology-San Martin
 John Allan Ellerton Ph: 702-384-0013
 HealthCare Partners Medical Group Oncology/Hematology-Tenaya
 John Allan Ellerton Ph: 702-384-0013
 Las Vegas Cancer Center-Medical Center
 John Allan Ellerton Ph: 702-384-0013
 Radiation Oncology Centers of Las Vegas - Downtown Location
 John Allan Ellerton Ph: 702-384-0013
 Radiation Oncology Centers of Las Vegas - Eastern Location
 John Allan Ellerton Ph: 702-384-0013
 University Medical Center of Southern Nevada
 John Allan Ellerton Ph: 702-384-0013
New York
  Middletown
 Tucker Center for Cancer Care at Orange Regional Medical Center
 Jeffrey M. Stewart Ph: 845-342-7609
  Rochester
 James P. Wilmot Cancer Center at University of Rochester Medical Center
 Jonathan W Friedberg Ph: 585-275-5830
North Carolina
  Charlotte
 Blumenthal Cancer Center at Carolinas Medical Center
 Saad Z Usmani Ph: 704-355-2884
  Concord
 Batte Cancer Center at Northeast Medical Center
 Saad Z Usmani Ph: 704-355-2884
  Kinston
 Kinston Medical Specialists
 Peter R. Watson Ph: 252-559-2200
  Monroe
 Edwards Cancer Center at Union Regional Medical Center
 Saad Z Usmani Ph: 704-355-2884
  Pinehurst
 FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
 Charles S Kuzma Ph: 910-715-2200
North Dakota
  Bismarck
 Medcenter One Hospital Cancer Care Center
 Preston D. Steen Ph: 701-234-6161
  Fargo
 Roger Maris Cancer Center at MeritCare Hospital
 Preston D. Steen Ph: 701-234-6161
 Preston D. Steen Ph: 701-234-6161
 Sanford Clinic North-Fargo
 Preston D. Steen Ph: 701-234-6161
Ohio
  Akron
 Summa Center for Cancer Care at Akron City Hospital
 Jennifer E Payne Ph: 330-375-6101
  Barberton
 Barberton Citizens Hospital
 Jennifer E Payne Ph: 330-375-6101
  Beachwood
 Cleveland Clinic Taussig Cancer Center
 Anjali S Advani Ph: 866-223-8100
  Belpre
 Strecker Cancer Center-Belpre
 J. Philip Kuebler Ph: 614-566-3275
  Bowling Green
 Wood County Oncology Center
 Rex B Mowat Ph: 517-265-0116
  Chillicothe
 Adena Regional Medical Center
 J. Philip Kuebler Ph: 614-566-3275
  Cleveland
 Case Comprehensive Cancer Center
 Erica L Campagnaro Ph: 800-641-2422
 Cleveland Clinic Cancer Center at Fairview Hospital
 Anjali S Advani Ph: 866-223-8100
 Cleveland Clinic Taussig Cancer Center
 Anjali S Advani Ph: 866-223-8100
  Columbus
 CCOP - Columbus
 J. Philip Kuebler Ph: 614-566-3275
 Columbus Oncology Associates, Incorporated
 J. Philip Kuebler Ph: 614-566-3275
 Doctors Hospital at Ohio Health
 J. Philip Kuebler Ph: 614-566-3275
 Grant Medical Center Cancer Care
 J. Philip Kuebler Ph: 614-566-3275
 Mount Carmel Health - West Hospital
 J. Philip Kuebler Ph: 614-566-3275
 Riverside Methodist Hospital Cancer Care
 J. Philip Kuebler Ph: 614-566-3275
 Zangmeister Center
 J. Philip Kuebler Ph: 614-566-3275
  Delaware
 Delaware Health Center
 J. Philip Kuebler Ph: 614-566-3275
 Delaware Radiation Oncology
 J. Philip Kuebler Ph: 614-566-3275
 Grady Memorial Hospital
 J. Philip Kuebler Ph: 614-566-3275
  Independence
 Cleveland Clinic Taussig Cancer Center
 Anjali S Advani Ph: 866-223-8100
  Lancaster
 Fairfield Medical Center
 J. Philip Kuebler Ph: 614-566-3275
 Lancaster Radiation Oncology at Fairfield Medical Center
 J. Philip Kuebler Ph: 614-566-3275
  Lima
 Lima Memorial Hospital
 Rex B Mowat Ph: 517-265-0116
  Marietta
 Strecker Cancer Center at Marietta Memorial Hospital
 J. Philip Kuebler Ph: 614-566-3275
  Maumee
 Northwest Ohio Oncology Center
 Rex B Mowat Ph: 517-265-0116
 Rex B Mowat Ph: 517-265-0116
  Mayfield Heights
 Hillcrest Cancer Center at Hillcrest Hospital
 Anjali S Advani Ph: 866-223-8100
  Medina
 Summa Health Center at Lake Medina
 Jennifer E Payne Ph: 330-375-6101
  Mentor
 Lake/University Ireland Cancer Center
 Erica L Campagnaro Ph: 800-641-2422
  Mount Vernon
 Knox Community Hospital
 J. Philip Kuebler Ph: 614-566-3275
  Newark
 Licking Memorial Cancer Care Program at Licking Memorial Hospital
 J. Philip Kuebler Ph: 614-566-3275
 Newark Radiation Oncology
 J. Philip Kuebler Ph: 614-566-3275
  Oregon
 St. Charles Mercy Hospital
 Rex B Mowat Ph: 517-265-0116
 Toledo Clinic - Oregon
 Rex B Mowat Ph: 517-265-0116
  Portsmouth
 Southern Ohio Medical Center Cancer Center
 J. Philip Kuebler Ph: 614-566-3275
  Sandusky
 North Coast Cancer Care, Incorporated
 Anjali S Advani Ph: 866-223-8100
 University Hospitals Ireland Cancer Center at Firelands Regional Medical Center
 Erica L Campagnaro Ph: 800-641-2422
  Springfield
 Community Hospital of Springfield and Clark County
 J. Philip Kuebler Ph: 614-566-3275
  Strongsville
 Cleveland Clinic Foundation - Strongsville
 Anjali S Advani Ph: 866-223-8100
  Sylvania
 Flower Hospital Cancer Center
 Rex B Mowat Ph: 517-265-0116
  Tiffin
 Mercy Hospital of Tiffin
 Rex B Mowat Ph: 517-265-0116
  Toledo
 CCOP - Toledo Community Hospital
 Rex B Mowat Ph: 517-265-0116
 St. Anne Mercy Hospital
 Rex B Mowat Ph: 517-265-0116
 St. Vincent Mercy Medical Center
 Rex B Mowat Ph: 517-265-0116
 Toledo Clinic, Incorporated - Main Clinic
 Rex B Mowat Ph: 517-265-0116
 University of Toledo Medical Center
 Rex B Mowat Ph: 517-265-0116
  Wauseon
 Fulton County Health Center
 Rex B Mowat Ph: 517-265-0116
  Westerville
 Mount Carmel St. Ann's Cancer Center
 J. Philip Kuebler Ph: 614-566-3275
  Wooster
 Cleveland Clinic - Wooster
 Anjali S Advani Ph: 866-223-8100
  Zanesville
 Genesis - Good Samaritan Hospital
 J. Philip Kuebler Ph: 614-566-3275
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 George B Selby Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
Oregon
  Clackamas
 Clackamas Radiation Oncology Center
 Alison K Conlin Ph: 503-215-6412
  Milwaukie
 Providence Milwaukie Hospital
 Alison K Conlin Ph: 503-215-6412
  Newberg
 Providence Newberg Medical Center
 Alison K Conlin Ph: 503-215-6412
  Oregon City
 Willamette Falls Hospital
 Alison K Conlin Ph: 503-215-6412
  Portland
 CCOP - Columbia River Oncology Program
 Alison K Conlin Ph: 503-215-6412
 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
 Southwest Oncology Group
 Saad Z Usmani Ph: 248-225-5642
  Email: saad.usmani@carolinashealthcare.org
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
  Lewisburg
 Geisinger Medical Oncology at Evangelical Community Hospital
 Edward J Gorak Ph: 570-271-5251
  Pottsville
 Geisinger Medical Oncology-Pottsville
 Edward J Gorak Ph: 570-271-5251
  State College
 Geisinger Medical Group - Scenery Park
 Edward J Gorak Ph: 570-271-5251
  Wilkes-Barre
 Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
 Edward J Gorak Ph: 570-271-5251
South Carolina
  Florence
 McLeod Regional Medical Center
 Rajesh Bajaj Ph: 843-679-7256
South Dakota
  Rapid City
 Rapid City Regional Hospital
 Mark T Schroeder Ph: 605-716-3982
  Email: research@rcrh.org
  Sioux Falls
 Sanford Cancer Center at Sanford USD Medical Center
 Miroslaw A Mazurczak Ph: 605-328-1367
 Miroslaw A Mazurczak Ph: 605-328-1367
Texas
  Houston
 Univeristy of Texas M.D. Anderson Cancer Center
 Robert Zygmunt Orlowski Ph: 713-792-3245
Virginia
  Fredericksburg
 Fredericksburg Oncology Inc
 Rex B Mowat Ph: 517-265-0116
  Martinsville
 Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
 Sreedhar Katragadda Ph: 276-666-7827
Washington
  Vancouver
 Northwest Cancer Specialists at Vancouver Cancer Center
 Alison K Conlin Ph: 503-215-6412
 Southwest Washington Medical Center Cancer Center
 Alison K Conlin Ph: 503-215-6412
Wisconsin
  Burlington
 Aurora Cancer Care-Burlington
 Dhimant R. Patel Ph: 800-252-2990
  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
 Matthew L Ryan Ph: 800-432-6049
 Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
 Matthew L Ryan Ph: 800-432-6049
 St. Mary's Hospital Medical Center - Green Bay
 Matthew L Ryan Ph: 800-432-6049
 St. Vincent Hospital Regional Cancer Center
 Matthew L Ryan Ph: 800-432-6049
 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
  Manitowoc
 Holy Family Memorial Medical Center Cancer Care Center
 Matthew L Ryan Ph: 800-432-6049
  Marinette
 Bay Area Cancer Care Center at Bay Area Medical Center
 Matthew L Ryan Ph: 800-432-6049
 Vince Lombardi Cancer Clinic - Marinette
 Dhimant R. Patel Ph: 800-252-2990
  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
 Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
 Dhimant R. Patel Ph: 800-252-2990
  New Richmond
 Cancer Center of Western Wisconsin
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Oconto Falls
 Green Bay Oncology, Limited - Oconto Falls
 Matthew L Ryan 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
  Sheboygan
 Saint Nicholas Hospital
 Matthew L Ryan Ph: 800-432-6049
 Vince Lombardi Cancer Clinic - Sheboygan
 Dhimant R. Patel Ph: 800-252-2990
  Sturgeon Bay
 Green Bay Oncology, Limited - Sturgeon Bay
 Matthew L Ryan 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
  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

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01668719
ClinicalTrials.gov processed this data on June 12, 2014

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

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