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Ipilimumab With or Without High-Dose Recombinant Interferon Alfa-2b 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 IIBiomarker/Laboratory analysis, TreatmentActive18 and overNCINCI-2012-01932
CDR0000741878, ECOG-E3611, E3611, U10CA021115, NCT01708941

Trial Description

Summary

This randomized phase II trial studies how well ipilimumab with or without high-dose recombinant interferon alpha-2b works in treating patients with stage III-IV melanoma that cannot be removed by surgery. Monoclonal antibodies, such as ipilimumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Recombinant interferon alfa-2b may interfere with the growth of tumor cells. It is not yet known whether ipilimumab is more effective with or without high-dose recombinant interferon alfa-2b in treating melanoma.

Further Study Information

PRIMARY OBJECTIVES:

I. Test the hypothesis that the combination of ipilimumab and high-dose interferon (HDI [recombinant interferon alfa-2b]) will improve progression free survival (PFS) of patients with advanced metastatic melanoma as compared to ipilimumab alone (across ipilimumab treatment status).

SECONDARY OBJECTIVES:

I. Test the hypothesis that the combination of ipilimumab and HDI will prove to be safe and tolerable.

II. Within the constraints of the sample size, attempt to test the hypotheses that (1) ipilimumab 10 mg/kg will lead to improved PFS in comparison to ipilimumab 3 mg/kg (across HDI treatment status); (2) the combination of ipilimumab and HDI will improve overall survival (OS) of patients with advanced metastatic melanoma as compared to ipilimumab alone (across ipilimumab treatment status) and (3) ipilimumab 10 mg/kg will lead to improved OS in comparison to ipilimumab 3 mg/kg (across HDI treatment status).

OUTLINE: Patients are randomized to 1 of 4 treatment arms.

ARM A:

INDUCTION PHASE: Patients receive higher dose ipilimumab intravenously (IV) over 90 minutes once every 3 weeks for 4 doses and recombinant interferon alfa-2b IV over 20 minutes five days a week for 4 weeks and then subcutaneously (SC) three times weekly for 8 weeks.

MAINTENANCE PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24 and recombinant interferon alfa-2b SC three times weekly for 48 weeks.

ARM B:

INDUCTION PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses.

MAINTENANCE PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24.

ARM C:

INDUCTION PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses and recombinant interferon alfa-2b IV over 20 minutes five days a week for 4 weeks and then SC three times weekly for 8 weeks.

MAINTENANCE PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24 and recombinant interferon alfa-2b SC three times weekly for 48 weeks.

ARM D:

INDUCTION PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses.

MAINTENANCE PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24.

In all arms, treatment continues in the absence of disease progression or unacceptable toxicity.

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

Eligibility Criteria

Inclusion Criteria:

  • Patients must have unresectable stage III or stage IV melanoma, either initial presentation or recurrent, that is of cutaneous origin or unknown primary origin, that is histologically diagnosed
  • No more than one prior systemic therapeutic regimen for unresectable stage III or stage IV melanoma; this includes chemotherapy, biologic therapy, biochemotherapy, or investigational treatment; this does not include any therapies given in the adjuvant setting; however, patients are excluded if they have a history of prior treatment for melanoma (either adjuvant or metastatic disease) with ipilimumab or other cytotoxic T-lymphocyte antigen 4 (CTLA-4) inhibitor, or prior interferon-alpha treatment for metastatic disease (history of adjuvant interferon-alpha is allowed)
  • Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Patients must not have other significant medical, surgical, or psychiatric conditions or require any medication or treatment that in the opinion of the investigator may interfere with compliance, make the administration of Ipilimumab or HDI hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrhea; patients must not have an active infection requiring current treatment with parenteral antibiotics
  • Patients must not have a history of inflammatory bowel disease or diverticulitis (history of diverticulosis is allowed)
  • Patients who have other current malignancies are not eligible; patients with other malignancies are eligible if they have been continuously disease free for > 5 years prior to the time of randomization; one exception are patients treated with a curative intent and are continuously disease free for > 3 years; these patients would be considered eligible:
  • Patients with prior history at any time of any in situ cancer, lobular carcinoma of the breast in situ, cervical cancer in situ, atypical melanocytic hyperplasia or Clark I melanoma in situ are eligible
  • Patients with prior history of basal or squamous skin cancer are eligible
  • Patients must not have autoimmune disorders or conditions of immunosuppression that require current ongoing treatment with systemic corticosteroids (or other systemic immunosuppressants), including oral steroids (e.g., prednisone, dexamethasone) or continuous use of topical steroid creams or ointments or ophthalmologic steroids; a history of occasional (but not continuous) use of steroid inhalers is allowed; replacement doses of steroids for patients with adrenal insufficiency are allowed; patients who discontinue use of these classes of medication for at least 2 weeks prior to randomization are eligible if, in the judgment of the treating physician investigator, the patient is not likely to require resumption of treatment with these classes of drugs during the study; exclusion from this study also includes patients with a history of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, Sjogren's syndrome, autoimmune vasculitis [e.g., Wegener's Granulomatosis]); motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre Syndrome and Myasthenia Gravis); other central nervous system (CNS) autoimmune disease (e.g., poliomyelitis, multiple sclerosis); patients with autoimmune hypothyroid disease or type I diabetes on replacement treatment are eligible
  • Due to the possible effect of treatment with ipilimumab on the immunologic response to infectious disease vaccines, patients must not have had any infectious disease vaccination (e.g, standard influenza, H1N1 influenza, pneumococcal, meningococcal, tetanus toxoid) within 4 weeks prior to randomization
  • Women must not be pregnant or breast-feeding due to the unknown effects of ipilimumab and the combination with HDI on conception and the fetus; all females of childbearing potential must have a blood test or urine study during screening to rule out pregnancy; NOTE: A woman of childbearing potential (WOCBP) is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 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); for the purposes of this study, post-menopause is defined as:
  • Amenorrhea >= 24 consecutive months without another cause, or
  • For women with irregular menstrual periods and taking hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level >= 35 mIU/mL Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential; men of fathering potential and WOCBP must be using an adequate method of contraception or must abstain from sexual intercourse to avoid conception/pregnancy throughout the study and for up to 26 weeks after the last dose of ipilimumab or HDI in such a manner that the risk of pregnancy is minimized; men or WOCBP who are unwilling or unable to strictly follow this requirement are not eligible
  • White blood cells (WBC) >= 3000/uL
  • Absolute neutrophil count (ANC) >= 1500/uL
  • Platelets >= 100 x 10^3/uL
  • Hemoglobin >= 10 g/dL
  • Serum creatinine =< 1.8 mg/dl
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN) for patients with liver metastases and =< 2.0 x ULN for patients without liver metastases
  • Serum bilirubin < 2 x ULN for patients with liver metastases and =< 1.5 x ULN for patients without liver metastases, (except patients with Gilbert's syndrome, who must have a total bilirubin < 3.0 mg/dL)
  • No active or chronic infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C due to the unknown effects of ipilimumab or the combination with HDI
  • Patients must be free of brain metastasis by contrast-enhanced computed tomography (CT)/magnetic resonance imaging (MRI) scans within 4 weeks prior to enrollment; if known to have prior brain metastases, must not have evidence of active brain disease after definitive therapy (surgery, radiation therapy or stereotactic radiosurgery) on two successive MRI evaluations at least 3 months apart (one of which is =< 4 weeks prior to starting the study drugs)
  • All sites of disease must be evaluated within 4 weeks prior to randomization; patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Trial Contact Information

Trial Lead Organizations/Sponsors

National Cancer Institute

Ahmad TarhiniPrincipal Investigator

Trial Sites

U.S.A.
Alabama
  Birmingham
 UAB Comprehensive Cancer Center
 Carla I. Falkson Ph: 205-934-0309
Colorado
  Aurora
 Medical Center of Aurora - South Campus
 Keren Sturtz Ph: 888-785-6789
  Boulder
 Boulder Community Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers-Boulder
 Keren Sturtz Ph: 888-785-6789
  Colorado Springs
 Penrose Cancer Center at Penrose Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers at the Pavilion
 Keren Sturtz Ph: 888-785-6789
  Denver
 Porter Adventist Hospital
 Keren Sturtz Ph: 888-785-6789
 Presbyterian - St. Luke's Medical Center
 Keren Sturtz Ph: 888-785-6789
 St. Joseph Hospital
 Keren Sturtz Ph: 888-785-6789
  Englewood
 Swedish Medical Center
 Keren Sturtz Ph: 888-785-6789
  Greeley
 North Colorado Medical Center
 Keren Sturtz Ph: 888-785-6789
  Lakewood
 St. Anthony Central Hospital
 Keren Sturtz Ph: 888-785-6789
  Littleton
 Littleton Adventist Hospital
 Keren Sturtz Ph: 888-785-6789
  Lone Tree
 Sky Ridge Medical Center
 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
  Wheat Ridge
 Exempla Lutheran Medical Center
 Keren Sturtz Ph: 888-785-6789
Connecticut
  Hartford
 Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
 Philip J. Stella Ph: 734-712-3456
Delaware
  Lewes
 Tunnell Cancer Center at Beebe Medical Center
 Gregory A. Masters Ph: 302-733-6227
  Newark
 Helen F. Graham Cancer Center at Christiana Hospital
 Gregory A. Masters Ph: 302-733-6227
  Seaford
 Nanticoke Memorial Hospital
 Gregory A. Masters Ph: 302-733-6227
Georgia
  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
 Philip J. Stella Ph: 734-712-3456
Illinois
  Aurora
 Rush-Copley Cancer Care Center
 James R Egner Ph: 800-446-5532
  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
  Carthage
 Illinois CancerCare - Carthage
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  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
 Galesburg Clinic, PC
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 Medical and Surgical Specialists, LLC
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Harvey
 Ingalls Cancer Care Center at Ingalls Memorial Hospital
 Mark F. Kozloff Ph: 708-915-4673
  Email: clinicaltrials@ingalls.org
  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
 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
  Monmouth
 Illinois CancerCare - Monmouth
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Normal
 Community Cancer Center
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Ottawa
 Community Hospital of Ottawa
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 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
 CCOP - Illinois Oncology Research Association
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 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
  Rockford
 Advanced Care and Treatment Medical Group, PC
 Harvey Eric Einhorn Ph: 779-696-9400
  Email: cancercare@swedishamerican.org
  Urbana
 Carle Cancer Center at Carle Foundation Hospital
 James R Egner Ph: 800-446-5532
Indiana
  Indianapolis
 Central Indiana Cancer Centers - East
 Hillary H Wu Ph: 317-356-2422
  Michigan City
 Saint Anthony Memorial Health Centers
 James R Egner Ph: 800-446-5532
Iowa
  Ames
 McFarland Clinic, PC
 Joseph James Merchant Ph: 515-239-2621
  Bettendorf
 Constantinou, Costas L MD (UIA Investigator)
 David M Spector Ph: 309-779-4200
  Clive
 Medical Oncology and Hematology Associates-West Des Moines
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
  Des Moines
 CCOP - Iowa Oncology Research Association
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 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
  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
  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
Louisiana
  Baton Rouge
 Ochsner Health Center - Bluebonnet
 Jyotsna Fuloria Ph: 888-562-4763
  New Orleans
 New Orleans Cancer Institute at Memorial Medical Center
 Jyotsna Fuloria Ph: 888-562-4763
 Ochsner Cancer Institute at Ochsner Clinic Foundation
 Jyotsna Fuloria Ph: 888-562-4763
Maryland
  Baltimore
 Greater Baltimore Medical Center Cancer Center
 Gary I. Cohen Ph: 443-849-3706
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
 Philip J. Stella Ph: 734-712-3456
 Saint Joseph Mercy Cancer Center
 Philip J. Stella Ph: 734-712-3456
  Dearborn
 Oakwood Cancer Center at Oakwood Hospital and Medical Center
 Philip J. Stella Ph: 734-712-3456
  Detroit
 Van Elslander Cancer Center at St. John Hospital and Medical Center
 Philip J. Stella Ph: 734-712-3456
  Escanaba
 Green Bay Oncology, Limited - Escanaba
 Gerald K. Bayer Ph: 800-432-6049
  Flint
 Genesys Hurley Cancer Institute
 Philip J. Stella Ph: 734-712-3456
 Hurley Medical Center
 Philip J. Stella Ph: 734-712-3456
  Iron Mountain
 Green Bay Oncology - Iron Mountain
 Gerald K. Bayer Ph: 800-432-6049
  Jackson
 Gayle M. Jacob Cancer Center at Allegiance Health
 Philip J. Stella Ph: 734-712-3456
  Lansing
 Sparrow Regional Cancer Center
 Philip J. Stella Ph: 734-712-3456
  Livonia
 St. Mary Mercy Hospital
 Philip J. Stella Ph: 734-712-3456
  Monroe
 Community Cancer Center of Monroe
 Rex B Mowat Ph: 517-265-0116
 Mercy Memorial Hospital - Monroe
 Rex B Mowat Ph: 517-265-0116
  Port Huron
 Mercy Regional Cancer Center at Mercy Hospital
 Philip J. Stella Ph: 734-712-3456
  Saginaw
 Seton Cancer Institute at Saint Mary's - Saginaw
 Philip J. Stella Ph: 734-712-3456
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
  Edina
 Fairview Southdale Hospital
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  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
  New Ulm
 New Ulm Medical Center
 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
  Saint Louis Park
 CCOP - Metro-Minnesota
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 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
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: 402-280-4100
  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: 402-280-4100
 Creighton University Medical Center
 Gamini S. Soori Ph: 402-280-4100
 Immanuel Medical Center
 Gamini S. Soori Ph: 402-280-4100
 Lakeside Hospital
 Gamini S. Soori Ph: 402-280-4100
New Jersey
  Camden
 Cancer Institute of New Jersey at Cooper University Hospital - Camden
 Gregory A. Masters Ph: 302-733-6227
  East Orange
 Veterans Affairs Medical Center - East Orange
 Basil S. Kasimis Ph: 800-475-2336
  Email: patricia.goyer@med.va.gov
  New Brunswick
 Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
 Janice M Mehnert Ph: 732-235-8675
New York
  Albany
 New York Oncology Hematology, PC at Albany Medical Center
 Charles H Weissman Ph: 518-489-3612ext1342
  Email: sharon.krause@usoncology.com
  Stony Brook
 Stony Brook University Cancer Center
 Andrzej P Kudelka Ph: 800-862-2215
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
  Bowling Green
 Wood County Oncology Center
 Rex B Mowat Ph: 517-265-0116
  Chillicothe
 Adena Regional Medical Center
 J. Philip Kuebler Ph: 800-446-5532
  Cleveland
 MetroHealth Cancer Care Center at MetroHealth Medical Center
 Bruce J. Averbook Ph: 216-778-8526
  Email: kbauchens@metrohealth.org
  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
 Grady Memorial Hospital
 J. Philip Kuebler Ph: 800-446-5532
  Lancaster
 Fairfield Medical Center
 J. Philip Kuebler Ph: 800-446-5532
  Lima
 Lima Memorial Hospital
 Rex B Mowat Ph: 517-265-0116
  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
  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
  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: 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
  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: 800-446-5532
  Zanesville
 Genesis - Good Samaritan Hospital
 J. Philip Kuebler Ph: 800-446-5532
Pennsylvania
  Danville
 Geisinger Cancer Institute at Geisinger Health
 Christian Adonizio Ph: 570-271-5251
  Hazleton
 Geisinger Hazleton Cancer Center
 Christian Adonizio Ph: 570-271-5251
  Philadelphia
 Fox Chase Cancer Center - Philadelphia
 Anthony J Olszanski Ph: 215-728-4790
  Pittsburgh
 UPMC Cancer Centers
 Ahmad A. Tarhini Ph: 412-647-8073
  State College
 Geisinger Medical Group - Scenery Park
 Christian Adonizio Ph: 570-271-5251
  Wilkes-Barre
 Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
 Christian Adonizio Ph: 570-271-5251
Virginia
  Fredericksburg
 Fredericksburg Oncology Inc
 Rex B Mowat Ph: 517-265-0116
West Virginia
  Charleston
 West Virginia University Medical School - Charleston
 Steven J. Jubelirer Ph: 304-344-3457
Wisconsin
  Green Bay
 Green Bay Oncology, Limited at St. Mary's Hospital
 Gerald K. Bayer Ph: 800-432-6049
 Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
 Gerald K. Bayer Ph: 800-432-6049
 St. Mary's Hospital Medical Center - Green Bay
 Gerald K. Bayer Ph: 800-432-6049
 St. Vincent Hospital Regional Cancer Center
 Gerald K. Bayer Ph: 800-432-6049
 Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
 Dhimant R. Patel Ph: 800-252-2990
  Johnson Creek
 UW Cancer Center Johnson Creek
 Mark R. Albertini Ph: 877-405-6866
  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
  Manitowoc
 Holy Family Memorial Medical Center Cancer Care Center
 Gerald K. Bayer Ph: 800-432-6049
  Marinette
 Bay Area Cancer Care Center at Bay Area Medical Center
 Gerald K. Bayer Ph: 800-432-6049
 Vince Lombardi Cancer Clinic - Marinette
 Dhimant R. Patel Ph: 800-252-2990
  Milwaukee
 Froedtert Hospital and Medical College of Wisconsin
 Stuart J. Wong Ph: 414-805-4380
 Wheaton Franciscan Cancer Care - St. Joseph
 Jonathan S. Treisman Ph: 414-427-2360
  New Richmond
 Cancer Center of Western Wisconsin
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Oconto Falls
 Green Bay Oncology, Limited - Oconto Falls
 Gerald K. Bayer Ph: 800-432-6049
  Sheboygan
 Saint Nicholas Hospital
 Gerald K. Bayer Ph: 800-432-6049
 Vince Lombardi Cancer Clinic - Sheboygan
 Dhimant R. Patel Ph: 800-252-2990
  Sturgeon Bay
 Green Bay Oncology, Limited - Sturgeon Bay
 Gerald K. Bayer 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
  Wauwatosa
 Oncology Alliance, SC - Milwaukee - West
 Rubina Qamar Ph: 888-709-2080

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01708941
ClinicalTrials.gov processed this data on December 09, 2013

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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