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Clinical Trials (PDQ®)

Ipilimumab With or Without Bevacizumab in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentActive18 and overNCINCI-2013-01732
ECOG-E3612, E3612, U10CA021115, U10CA180820, NCT01950390

Trial Description

Summary

This randomized phase II trial studies how well ipilimumab with or without bevacizumab works in treating patients with stage III-IV melanoma that cannot be removed by surgery. Monoclonal antibodies, such as ipilimumab and bevacizumab, block tumor growth in different ways by targeting certain cells.

Further Study Information

PRIMARY OBJECTIVES:

I. To compare overall survival for patients receiving ipilimumab plus bevacizumab versus ipilimumab alone.

SECONDARY OBJECTIVES:

I. To evaluate the progression free survival, response rate and safety in patients receiving ipilimumab plus bevacizumab versus ipilimumab alone.

II. To evaluate the utility of immune related response criteria (irRC) in patients receiving ipilimumab plus bevacizumab versus ipilimumab alone.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A:

INDUCTION THERAPY: Patients receive ipilimumab intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Beginning course 8, patients receive ipilimumab IV over 90 minutes on day 1. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.

ARM B:

INDUCTION THERAPY: Patients receive ipilimumab IV over 90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Patients receive bevacizumab as in Induction Therapy. Beginning course 8, patients also receive ipilimumab IV over 90 minutes on day 1. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 5 years.

Eligibility Criteria

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1
  • Untreated or previously received one treatment for measurable unresectable stage III or stage IV melanoma (American Joint Committee on Cancer [AJCC] 2010) (regardless of v-raf murine sarcoma viral oncogene homolog B [BRAF] mutation status or human leukocyte antigen [HLA] type); this does not include any therapies given in the adjuvant setting
  • Prior treatment (chemo, radiation, hormone, and immune therapies) must be completed > 4 weeks prior to randomization (> 6 weeks prior to randomization for nitrosoureas, mitomycin C, and checkpoint inhibitors)
  • Patients who received prior therapy with anthracyclines should have a baseline multigated acquisition (MUGA) or echo with a normal ejection fraction within 28 days prior to randomization
  • Patients must have recovered from any acute toxicity associated with prior therapy by the start of study treatment
  • Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
  • All sites of disease must be evaluated within 4 weeks prior to randomization; patients must have measurable disease
  • White blood cell (WBC) >= 2000/uL
  • Absolute neutrophil count (ANC) >= 1000/uL
  • Platelets >= 75 x 10^3/uL
  • Hemoglobin >= 9 g/dL
  • Creatinine =< 2.0 x upper limit of normal (ULN)
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x ULN for patients without liver metastases and =< 5 x ULN for patients with liver metastases
  • Serum bilirubin =< 2.0 x ULN (except patients with Gilbert's syndrome, who must have a total bilirubin less than 3.0 mg/dL)
  • Patients BRAF mutation status must be known
  • No concomitant therapy with any of the following: interleukin (IL) 2, interferon, or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigational therapies; or chronic use of systemic corticosteroids; must have been discontinued >= 4 weeks prior to randomization
  • No infection with human immunodeficiency virus (HIV)
  • No active infection with hepatitis B
  • No active or chronic infection with hepatitis C
  • Patients are ineligible if they have any history of central nervous system (CNS) metastases
  • Patients are ineligible if they have a history of any other malignancy from which the patient has been disease-free for less than 2 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix
  • Patients are ineligible if they have a history of autoimmune disease, as follows: Patients with a history of inflammatory bowel disease are excluded from this study as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener's granulomatosis]); patients with motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre Syndrome and myasthenia gravis) are excluded.; patients with a history of autoimmune thyroiditis are eligible if their current thyroid disorder is treated and stable with replacement or other medical therapy
  • Patients are ineligible if they have an active infection
  • Patients are ineligible if they have a history of prior treatment with ipilimumab, bevacizumab, or prior tumor necrosis factor receptor superfamily, member 9 (CD137) agonist or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitor or agonist
  • Patients are ineligible if they have a history of any underlying medical or psychiatric conditions or require any medications or treatment that in the opinion of the principal investigator may interfere with compliance, make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrhea
  • Patients are ineligible if they have any concurrent medical condition requiring the use of systemic steroids; (use of inhaled or topical steroids is acceptable)
  • Patients are ineligible if they have inadequately controlled hypertension (defined as systolic blood pressure > 150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications)
  • Patients are excluded if they have any prior history of hypertensive crisis or hypertensive encephalopathy
  • Patients are excluded if they have New York Heart Association (NYHA) grade II or greater congestive heart failure
  • Patients are excluded if they have a history of myocardial infarction or unstable angina within 6 months prior to randomization
  • Patients are excluded if they have a history of stroke or transient ischemic attack within 6 months prior to randomization
  • Patients are excluded if they have known significant vascular disease (e.g., aortic aneurysm, aortic dissection)
  • Patients are excluded if they have symptomatic peripheral vascular disease
  • Patients are excluded if they have evidence of bleeding diathesis or coagulopathy
  • Patients are excluded if they have had a surgical procedure or a significant traumatic injury within 28 days prior to randomization
  • Patients are excluded if they have had a biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to randomization
  • Patients are excluded if they have history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to randomization
  • Patients are excluded if they have a non-healing wound or ulcer
  • Patients are excluded if they have proteinuria at screening as demonstrated by either:
  • Urine dipstick for proteinuria >= 2+ (patients discovered to have >= 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate =< 1g of protein in 24 hours to be eligible) OR
  • Urine protein: creatinine (UPC) ratio >= 1.0 at screening; for UPC ratio > 1, a 24 hour urine protein should be obtained and the level should be < 1000mg; NOTE: Urine protein should be screened by urine analysis for UPC ratio; a UPC ratio of 1 is roughly equivalent to a 24-hour urine protein of 1g
  • Patients must not have known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
  • Patients are excluded if they have a history of hemoptysis (bright red blood of 1/2 teaspoon or more per episode) within 3 months prior to randomization
  • Patients are excluded if they have current, ongoing treatment with full-dose warfarin or its equivalent (i.e., unfractionated and/or low molecular weight heparin); subjects should have not taken full-dose warfarin or equivalent for at least 2 weeks prior to randomization
  • Patients are excluded if they have current or recent (within 10 days of enrollment) use of aspirin (> 325 mg/day) or chronic use of other non-steroidal anti-inflammatory drugs (NSAID)
  • Patients are excluded if they use medications that inhibit platelet function (e.g., dipyridamole, epoprostenol, eptifibatide, clopidogrel, cilostazol, abciximab, ticlopidine, and ibuprofen and related compounds) unless subject has been off treatment for at least 2 weeks prior to randomization
  • Patients are excluded if they have known involvement of melanoma within the gastrointestinal tract
  • Patients are excluded for any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab)
  • Women of childbearing potential and sexually active males must agree to practice abstinence or use an accepted and effective method of contraception

Trial Contact Information

Trial Lead Organizations/Sponsors

National Cancer Institute

Frank HodiPrincipal Investigator

Trial Sites

U.S.A.
Alabama
  Mobile
 University of South Alabama Mitchell Cancer Institute
 Thomas W Butler Ph: 251-445-9870
  Email: pfrancisco@usouthal.edu
Connecticut
  Hartford
 Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
 Tareq Al Baghdadi Ph: 734-712-4673
  Stamford
 Carl and Dorothy Bennett Cancer Center at Stamford Hospital
 Salvatore A. Del Prete Ph: 203-323-8944
District of Columbia
  Washington
 Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
 Michael Benjamin Atkins Ph: 202-444-0381
Florida
  Lakeland
 Lakeland Regional Cancer Center at Lakeland Regional Medical Center
 Madhavi L. Venigalla Ph: 863-904-1900
Georgia
  Atlanta
 Winship Cancer Institute of Emory University
 David H. Lawson Ph: 404-778-1868
  Savannah
 Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
 Howard A. Zaren Ph: 800-622-6877
Idaho
  Boise
 Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
 Tareq Al Baghdadi Ph: 734-712-4673
Illinois
  Bloomington
 Illinois CancerCare - Bloomington
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 St. Joseph Medical Center
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Canton
 Illinois CancerCare - Canton
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Carbondale
 Memorial Hospital of Carbondale
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Carthage
 Illinois CancerCare - Carthage
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Centralia
 Centralia Oncology Clinic
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Chicago
 Saint Joseph Hospital
 Ira Oliff Ph: 312-695-1301
  Email: cancer@northwestern.edu
  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
  Eureka
 Illinois CancerCare - Eureka
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Galesburg
 Galesburg Clinic, PC
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 Medical and Surgical Specialists, LLC
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Hinsdale
 Hinsdale Hematology Oncology Associates
 Elyse Cheryl Schneiderman Ph: 630-654-1790
  Email: info@hhoaltd.com
  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
  Moline
 Garneau, Stewart C 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
  Ottawa
 Illinois CancerCare - Ottawa
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Pekin
 Cancer Treatment Center at Pekin Hospital
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 Illinois CancerCare - Pekin
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Peoria
 Illinois CancerCare - Peoria
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 Methodist Medical Center of Illinois
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 OSF St. Francis Medical Center
 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
  Springfield
 Regional Cancer Center at Memorial Medical Center
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
Indiana
  Indianapolis
 Indiana University Melvin and Bren Simon Cancer Center
 Theodore F. Logan Ph: 317-274-2552
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
  Clive
 Medical Oncology and Hematology Associates-West Des Moines
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
  Des Moines
 John Stoddard Cancer Center at Iowa Lutheran Hospital
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 John Stoddard Cancer Center at Iowa Methodist Medical Center
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 Medical Oncology and Hematology Associates at John Stoddard Cancer Center
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 Medical Oncology and Hematology Associates at Mercy Cancer Center
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
  Jefferson
 McFarland Clinic PC-Jefferson
 Joseph James Merchant Ph: 515-239-2621
  Marshalltown
 McFarland Clinic PC-Marshalltown
 Joseph James Merchant Ph: 515-239-2621
  Mason City
 Mercy Cancer Center at Mercy Medical Center - North Iowa
 Arvind Y Vemula Ph: 800-433-3883
  Ottumwa
 South Iowa Radiation Oncology Center at Ottumwa Regional Health Center
 Praveen Vikas Ph: 641-684-2742
  Sioux City
 Siouxland Hematology-Oncology Associates, LLP
 Donald Bruce Wender Ph: 712-252-0088
  West Des Moines
 Methodist West Hospital
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
Kansas
  Chanute
 Cancer Center of Kansas, PA - Chanute
 Shaker R. Dakhil Ph: 316-262-4467
  Dodge City
 Cancer Center of Kansas, PA - Dodge City
 Shaker R. Dakhil Ph: 316-262-4467
  El Dorado
 Cancer Center of Kansas, PA - El Dorado
 Shaker R. Dakhil Ph: 316-262-4467
  Fort Scott
 Cancer Center of Kansas - Fort Scott
 Shaker R. Dakhil Ph: 316-262-4467
  Independence
 Cancer Center of Kansas-Independence
 Shaker R. Dakhil Ph: 316-262-4467
  Kingman
 Cancer Center of Kansas, PA - Kingman
 Shaker R. Dakhil Ph: 316-262-4467
  Lawrence
 Lawrence Memorial Hospital
 Shaker R. Dakhil Ph: 316-262-4467
  Liberal
 Cancer Center of Kansas, PA - Liberal
 Shaker R. Dakhil Ph: 316-262-4467
  Manhattan
 Cancer Center of Kansas-Manhattan
 Shaker R. Dakhil Ph: 316-262-4467
  McPherson
 Cancer Center of Kansas, PA - McPherson
 Shaker R. Dakhil Ph: 316-262-4467
  Newton
 Cancer Center of Kansas, PA - Newton
 Shaker R. Dakhil Ph: 316-262-4467
  Parsons
 Cancer Center of Kansas, PA - Parsons
 Shaker R. Dakhil Ph: 316-262-4467
  Pratt
 Cancer Center of Kansas, PA - Pratt
 Shaker R. Dakhil Ph: 316-262-4467
  Salina
 Cancer Center of Kansas, PA - Salina
 Shaker R. Dakhil Ph: 316-262-4467
  Wellington
 Cancer Center of Kansas, PA - Wellington
 Shaker R. Dakhil Ph: 316-262-4467
  Wichita
 Associates in Women's Health, PA - North Hillside
 Shaker R. Dakhil Ph: 316-262-4467
 Cancer Center of Kansas, PA - Medical Arts Tower
 Shaker R. Dakhil Ph: 316-262-4467
 Cancer Center of Kansas, PA - Wichita
 Shaker R. Dakhil Ph: 316-262-4467
 CCOP - Wichita
 Shaker R. Dakhil Ph: 316-262-4467
 Via Christi Cancer Center at Via Christi Regional Medical Center
 Shaker R. Dakhil Ph: 316-262-4467
  Winfield
 Cancer Center of Kansas, PA - Winfield
 Shaker R. Dakhil Ph: 316-262-4467
Massachusetts
  Boston
 Beth Israel Deaconess Medical Center
 F. Stephen Hodi Ph: 866-790-4500
 Dana-Farber/Brigham and Women's Cancer Center
 F. Stephen Hodi Ph: 866-790-4500
 Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
 F. Stephen Hodi Ph: 866-790-4500
 Massachusetts General Hospital
 F. Stephen Hodi Ph: 866-790-4500
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
 Saint Joseph Mercy Cancer Center
 Tareq Al Baghdadi Ph: 734-712-4673
  Dearborn
 Oakwood Cancer Center at Oakwood Hospital and Medical Center
 Tareq Al Baghdadi Ph: 734-712-4673
  Detroit
 Van Elslander Cancer Center at St. John Hospital and Medical Center
 Tareq Al Baghdadi Ph: 734-712-4673
  Flint
 Genesys Hurley Cancer Institute
 Tareq Al Baghdadi Ph: 734-712-4673
 Hurley Medical Center
 Tareq Al Baghdadi Ph: 734-712-4673
  Jackson
 Gayle M. Jacob Cancer Center at Allegiance Health
 Tareq Al Baghdadi Ph: 734-712-4673
  Kalamazoo
 Borgess Medical Center
 Raymond Sterling Lord Ph: 269-373-7458
 Bronson Methodist Hospital
 Raymond Sterling Lord Ph: 269-373-7458
 West Michigan Cancer Center
 Raymond Sterling Lord Ph: 269-373-7458
  Lansing
 Sparrow Regional Cancer Center
 Tareq Al Baghdadi Ph: 734-712-4673
  Livonia
 St. Mary Mercy Hospital
 Tareq Al Baghdadi Ph: 734-712-4673
  Pontiac
 St. Joseph Mercy Oakland
 Tareq Al Baghdadi Ph: 734-712-4673
  Port Huron
 Mercy Regional Cancer Center at Mercy Hospital
 Tareq Al Baghdadi Ph: 734-712-4673
  Saginaw
 Seton Cancer Institute at Saint Mary's - Saginaw
 Tareq Al Baghdadi Ph: 734-712-4673
  Warren
 St. John Macomb Hospital
 Tareq Al Baghdadi Ph: 734-712-4673
Minnesota
  Bemidji
 MeritCare Bemidji
 Preston D. Steen Ph: 701-234-6161
Missouri
  Cape Girardeau
 Saint Francis Medical Center
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
Nebraska
  Lincoln
 Cancer Resource Center - Lincoln
 Gamini S. Soori Ph: 402-398-6060
  Omaha
 Alegant Health Cancer Center at Bergan Mercy Medical Center
 Gamini S. Soori Ph: 402-280-4100
 CCOP - Missouri Valley Cancer Consortium
 Gamini S. Soori Ph: 402-398-6060
 Immanuel Medical Center
 Gamini S. Soori Ph: 402-280-4100
 Lakeside Hospital
 Gamini S. Soori Ph: 402-280-4100
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 Jersey
  Hackensack
 CCOP - Northern New Jersey
 Donna T McNamara Ph: 201-996-2879
  Vineland
 Frank and Edith Scarpa Regional Cancer Pavillion at South Jersey Healthcare
 Benjamin P Negin Ph: 856-641-7933
New York
  Bronx
 Jack D. Weiler Hospital at Montefiore Medical Center - East Campus
 Stuart H Packer Ph: 718-904-2730
  Email: aecc@aecom.yu.edu
 Montefiore Medical Center
 Stuart H Packer Ph: 718-904-2730
  Email: aecc@aecom.yu.edu
  Cooperstown
 Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital
 Eric Bravin Ph: 607-547-3073
  Email: diana.crean@bassett.org
  White Plains
 Dickstein Cancer Treatment Center at White Plains Hospital Center
 Dan Costin Ph: 914-681-2290
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
  Belpre
 Strecker Cancer Center-Belpre
 J. Philip Kuebler Ph: 800-446-5532
  Canton
 Aultman Cancer Center at Aultman Hospital
 James A. Schmotzer Ph: 330-363-6891
  Chillicothe
 Adena Regional Medical Center
 J. Philip Kuebler Ph: 800-446-5532
  Cleveland
 Case Comprehensive Cancer Center
 Henry B Koon Ph: 800-641-2422
  Columbus
 CCOP - Columbus
 J. Philip Kuebler Ph: 800-446-5532
 Columbus Oncology Associates, Incorporated
 J. Philip Kuebler Ph: 800-446-5532
 Doctors Hospital at Ohio Health
 J. Philip Kuebler Ph: 800-446-5532
 Grant Medical Center Cancer Care
 J. Philip Kuebler Ph: 800-446-5532
 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
  Delaware
 Delaware Health Center
 J. Philip Kuebler Ph: 800-446-5532
 Delaware Radiation Oncology
 J. Philip Kuebler Ph: 614-566-3275
 Grady Memorial Hospital
 J. Philip Kuebler Ph: 800-446-5532
  Lancaster
 Fairfield Medical Center
 J. Philip Kuebler Ph: 800-446-5532
 Lancaster Radiation Oncology at Fairfield Medical Center
 J. Philip Kuebler Ph: 614-566-3275
  Marietta
 Strecker Cancer Center at Marietta Memorial Hospital
 J. Philip Kuebler Ph: 800-446-5532
  Maumee
 Northwest Ohio Oncology Center
 Rex B Mowat Ph: 517-265-0116
 Rex B Mowat Ph: 517-265-0116
  Mount Vernon
 Knox Community 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
 Newark Radiation Oncology
 J. Philip Kuebler Ph: 614-566-3275
  Oregon
 St. Charles Mercy Hospital
 Rex B Mowat Ph: 517-265-0116
  Portsmouth
 Southern Ohio Medical Center Cancer Center
 J. Philip Kuebler Ph: 800-446-5532
  Springfield
 Community Hospital of Springfield and Clark County
 J. Philip Kuebler Ph: 800-446-5532
  Sylvania
 Flower Hospital Cancer Center
 Rex B Mowat Ph: 517-265-0116
  Toledo
 St. Anne Mercy Hospital
 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
  Westerville
 Mount Carmel St. Ann's Cancer Center
 J. Philip Kuebler Ph: 800-446-5532
  Zanesville
 Genesis - Good Samaritan Hospital
 J. Philip Kuebler Ph: 800-446-5532
Pennsylvania
  Doylestown
 Doylestown Hospital Cancer Center
 Mitchell Alden Ph: 215-345-2378
  Email: lheacock@dh.org
  Hershey
 Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
 Joseph Drabick Ph: 717-531-3779
  Email: CTO@hmc.psu.edu
  Lancaster
 Lancaster General Hospital
 Shanthi Sivendran Ph: 717-544-5511
  Philadelphia
 Fox Chase Cancer Center - Philadelphia
 Sujana Movva Ph: 215-728-4790
  Pittsburgh
 UPMC Cancer Centers
 Ahmad A. Tarhini Ph: 412-647-8073
  Scranton
 Scranton Hematology Oncology
 Martin B. Hyzinski Ph: 570-558-3020
  West Chester
 Cancer Center of Chester County
 William E. Luginbuhl Ph: 610-431-5297
  West Reading
 McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
 Terrence P. Cescon Ph: 610-988-9323
South Dakota
  Sioux Falls
 Sanford Cancer Center at Sanford USD Medical Center
 Miroslaw A Mazurczak Ph: 605-328-1367
 Miroslaw A Mazurczak Ph: 605-328-1367
West Virginia
  Morgantown
 Mary Babb Randolph Cancer Center at West Virginia University Hospitals
 Manish Monga Ph: 304-293-2745
  Email: sfilburn@hsc.wvu.edu
Wisconsin
  Antigo
 Langlade Memorial Hospital
 Hamied R. Rezazadeh Ph: 877-405-6866
  Eau Claire
 Center for Cancer Treatment & Prevention at Sacred Heart Hospital
 Seth Olusegun Fagbemi Ph: 715-389-4457
 Marshfield Clinic Cancer Care at Regional Cancer Center
 Seth Olusegun Fagbemi Ph: 715-389-4457
  Green Bay
 Bellin Memorial Hospital
 Patrick J Mansky Ph: 920-435-8326
  La Crosse
 Gundersen Lutheran Center for Cancer and Blood
 Kurt Oettel Ph: 608-775-2385
  Email: cancerctr@gundluth.org
  Madison
 University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
 Mark R. Albertini Ph: 877-405-6866
  Marshfield
 Marshfield Clinic - Marshfield Center
 Seth Olusegun Fagbemi Ph: 715-389-4457
 Saint Joseph's Hospital
 Seth Olusegun Fagbemi Ph: 715-389-4457
  Milwaukee
 Froedtert Hospital and Medical College of Wisconsin
 Stuart J. Wong Ph: 414-805-4380
  Minocqua
 Marshfield Clinic - Lakeland Center
 Seth Olusegun Fagbemi Ph: 715-389-4457
  Oconomowoc
 Regional Cancer Center at Oconomowoc Memorial Hospital
 Timothy R Wassenaar Ph: 262-928-7878
  Rhinelander
 Ministry Medical Group at Saint Mary's Hospital
 Seth Olusegun Fagbemi Ph: 715-389-4457
 Seth Olusegun Fagbemi Ph: 715-389-4457
  Rice Lake
 Marshfield Clinic - Indianhead Center
 Seth Olusegun Fagbemi Ph: 715-389-4457
  Stevens Point
 Marshfield Clinic at Saint Michael's Hospital
 Seth Olusegun Fagbemi Ph: 715-389-4457
 Saint Michael's Hospital Cancer Center
 Seth Olusegun Fagbemi Ph: 715-389-4457
  Waukesha
 Waukesha Memorial Hospital Regional Cancer Center
 Timothy R Wassenaar Ph: 262-928-7878
  Wausau
 Marshfield Clinic - Wausau Center
 Seth Olusegun Fagbemi Ph: 715-389-4457
 University of Wisconcin Cancer Center at Aspirus Wausau Hospital
 Hamied R. Rezazadeh Ph: 877-405-6866
  Weston
 Diagnostic and Treatment Center
 Seth Olusegun Fagbemi Ph: 715-389-4457
 Marshfield Clinic - Weston Center
 Seth Olusegun Fagbemi Ph: 715-389-4457
 Ministry Saint Clare's Hospital
 Seth Olusegun Fagbemi Ph: 715-389-4457
  Wisconsin Rapids
 Marshfield Clinic - Wisconsin Rapids Center
 Seth Olusegun Fagbemi Ph: 715-389-4457
 Riverview UW Cancer Center at Riverview Hospital
 Ron James Kirschling Ph: 877-405-6866

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01950390
ClinicalTrials.gov processed this data on August 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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