Ipilimumab with or without High-Dose Recombinant Interferon Alfa-2b in Treating Patients with Stage III-IV Melanoma That Cannot Be Removed by Surgery

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Basic Trial Information

PhaseTypeAgeTrial IDs
Phase IIBiomarker/Laboratory analysis, Treatment18 and overE3611
NCI-2012-01932, CDR0000741878, ECOG-E3611, 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, may block tumor growth by targeting certain cells. 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 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

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 have unresectable stage III or stage IV melanoma, either initial presentation or recurrent, that is of cutaneous origin or unknown primary origin and that is histologically diagnosed

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

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)

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)

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 creatinine =< 1.8 mg/dl

Hemoglobin >= 10 g/dL

Platelets >= 100 x 10^3/uL

Absolute neutrophil count (ANC) >= 1500/uL

White blood cells (WBC) >= 3000/uL

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

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 a history of inflammatory bowel disease or diverticulitis (history of diverticulosis is allowed)

Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

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); there should be a 4-week washout period between last treatment administration and initiation of study therapy

Women must not be pregnant or breast-feeding; 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

No active or chronic infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

National Cancer Institute

  • National Cancer Institute
Ahmad A. Tarhini, Principal Investigator

Trial Sites

U.S.A.

Alabama
Birmingham

University of Alabama at Birmingham Cancer Center

Robert Martin Conry
Ph: 205-934-0309

Robert Martin Conry
Principal Investigator

Connecticut
Hartford

Saint Francis Hospital and Medical Center

Philip J. Stella
Ph: 734-712-4673

Philip J. Stella
Principal Investigator

Delaware
Lewes

Beebe Medical Center

Gregory Andrew Masters
Ph: 302-733-6227

Gregory Andrew Masters
Principal Investigator

Newark

Christiana Care Health System-Christiana Hospital

Gregory Andrew Masters
Ph: 302-733-6227

Gregory Andrew Masters
Principal Investigator

Christiana Gynecologic Oncology LLC

Gregory Andrew Masters
Ph: 302-733-6227

Gregory Andrew Masters
Principal Investigator

Delaware Clinical and Laboratory Physicians PA

Gregory Andrew Masters
Ph: 302-733-6227

Gregory Andrew Masters
Principal Investigator

Helen F Graham Cancer Center

Gregory Andrew Masters
Ph: 302-733-6227

Gregory Andrew Masters
Principal Investigator

Medical Oncology Hematology Consultants PA

Gregory Andrew Masters
Ph: 302-733-6227

Gregory Andrew Masters
Principal Investigator

Regional Hematology and Oncology PA

Gregory Andrew Masters
Ph: 302-733-6227

Gregory Andrew Masters
Principal Investigator

Rehoboth Beach

Beebe Health Campus

Gregory Andrew Masters
Ph: 302-733-6227

Gregory Andrew Masters
Principal Investigator

Seaford

Nanticoke Memorial Hospital

Gregory Andrew Masters
Ph: 302-733-6227

Gregory Andrew Masters
Principal Investigator

Wilmington

Christiana Care Health System-Wilmington Hospital

Gregory Andrew Masters
Ph: 302-733-6227

Gregory Andrew Masters
Principal Investigator

Georgia
Savannah

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Howard A. Zaren
Ph: 800-622-6877

Howard A. Zaren
Principal Investigator

Idaho
Boise

Saint Alphonsus Cancer Care Center-Boise

Philip J. Stella
Ph: 734-712-4673

Philip J. Stella
Principal Investigator

Illinois
Bloomington

Illinois CancerCare-Bloomington

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

Nguyet Anh Le-Lindqwister
Principal Investigator

Saint Joseph Medical Center

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

Nguyet Anh Le-Lindqwister
Principal Investigator

Canton

Illinois CancerCare-Canton

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

Nguyet Anh Le-Lindqwister
Principal Investigator

Carthage

Illinois CancerCare-Carthage

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

Nguyet Anh Le-Lindqwister
Principal Investigator

Centralia

Centralia Oncology Clinic

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

James Lloyd Wade
Principal Investigator

Chicago

Northwestern University

Timothy M. Kuzel
Ph: 312-695-1301
Email: cancer@northwestern.edu

Timothy M. Kuzel
Principal Investigator

Decatur

Cancer Care Center of Decatur

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

James Lloyd Wade
Principal Investigator

Decatur Memorial Hospital

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

James Lloyd Wade
Principal Investigator

Effingham

Crossroads Cancer Center

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

James Lloyd Wade
Principal Investigator

Eureka

Illinois CancerCare-Eureka

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

Nguyet Anh Le-Lindqwister
Principal Investigator

Galesburg

Illinois CancerCare Galesburg

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

Nguyet Anh Le-Lindqwister
Principal Investigator

Illinois CancerCare-Galesburg Cottage Plaza Office

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

Nguyet Anh Le-Lindqwister
Principal Investigator

Western Illinois Cancer Treatment Center

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

James Lloyd Wade
Principal Investigator

Harvey

Ingalls Memorial Hospital

Mark Farrell Kozloff
Ph: 708-915-4673
Email: clinicaltrials@ingalls.org

Mark Farrell Kozloff
Principal Investigator

Highland Park

Hematology Oncology Associates of Illinois-Highland Park

Timothy M. Kuzel
Ph: 312-695-1301
Email: cancer@northwestern.edu

Timothy M. Kuzel
Principal Investigator

Libertyville

North Shore Hematology Oncology

Timothy M. Kuzel
Ph: 312-695-1301
Email: cancer@northwestern.edu

Timothy M. Kuzel
Principal Investigator

Macomb

Illinois CancerCare-Macomb

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

Nguyet Anh Le-Lindqwister
Principal Investigator

Moline

Garneau, Stewart C MD (UIA Investigator)

David Martens Spector
Ph: 309-779-4200

David Martens Spector
Principal Investigator

Spector, David MD (UIA Investigator)

David Martens Spector
Ph: 309-779-4200

David Martens Spector
Principal Investigator

Trinity Medical Center

David Martens Spector
Ph: 309-779-4200

David Martens Spector
Principal Investigator

Niles

Illinois Cancer Specialists-Niles

Timothy M. Kuzel
Ph: 312-695-1301
Email: cancer@northwestern.edu

Timothy M. Kuzel
Principal Investigator

Ottawa

Illinois CancerCare-Ottawa Clinic

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

Nguyet Anh Le-Lindqwister
Principal Investigator

Pekin

Illinois CancerCare-Pekin

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

Nguyet Anh Le-Lindqwister
Principal Investigator

Pekin Cancer Treatment Center

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

Nguyet Anh Le-Lindqwister
Principal Investigator

Peoria

Illinois CancerCare-Peoria

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

Nguyet Anh Le-Lindqwister
Principal Investigator

Methodist Medical Center of Illinois

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

Nguyet Anh Le-Lindqwister
Principal Investigator

OSF Saint Francis Medical Center

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

Nguyet Anh Le-Lindqwister
Principal Investigator

OSF Saint Francis Medical Center Radiation Oncology Service at the Central Illinois Comprehensive CC

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

James Lloyd Wade
Principal Investigator

Peru

Illinois CancerCare-Peru

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

Nguyet Anh Le-Lindqwister
Principal Investigator

Valley Radiation Oncology

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

James Lloyd Wade
Principal Investigator

Rockford

SwedishAmerican Regional Cancer Center/ACT

Harvey E. Einhorn
Ph: 779-696-9400
Email: cancercare@swedishamerican.org

Harvey E. Einhorn
Principal Investigator

Skokie

Hematology Oncology Associates of Illinois - Skokie

Timothy M. Kuzel
Ph: 312-695-1301
Email: cancer@northwestern.edu

Timothy M. Kuzel
Principal Investigator

Springfield

Central Illinois Hematology Oncology Center

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

James Lloyd Wade
Principal Investigator

Memorial Medical Center

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

James Lloyd Wade
Principal Investigator

Southern Illinois University School of Medicine

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

James Lloyd Wade
Principal Investigator

Springfield Clinic

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

James Lloyd Wade
Principal Investigator

Swansea

Cancer Care Specialists of Illinois-Swansea

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

James Lloyd Wade
Principal Investigator

Iowa
Ames

Mary Greeley Medical Center

Joseph James Merchant
Ph: 515-239-2621

Joseph James Merchant
Principal Investigator

McFarland Clinic PC-William R Bliss Cancer Center

Joseph James Merchant
Ph: 515-239-2621

Joseph James Merchant
Principal Investigator

Bettendorf

Constantinou, Costas L MD (UIA Investigator)

David Martens Spector
Ph: 309-779-4200

David Martens Spector
Principal Investigator

Boone

McFarland Clinic PC-Boone

Joseph James Merchant
Ph: 515-239-2621

Joseph James Merchant
Principal Investigator

Des Moines

Iowa Lutheran Hospital

Robert J. Behrens
Ph: 515-282-2921

Robert J. Behrens
Principal Investigator

Iowa Methodist Medical Center

Robert J. Behrens
Ph: 515-282-2921

Robert J. Behrens
Principal Investigator

Medical Oncology and Hematology Associates-Des Moines

Robert J. Behrens
Ph: 515-282-2921

Robert J. Behrens
Principal Investigator

Fort Dodge

McFarland Clinic PC-Trinity Cancer Center

Joseph James Merchant
Ph: 515-239-2621

Joseph James Merchant
Principal Investigator

Jefferson

McFarland Clinic PC-Jefferson

Joseph James Merchant
Ph: 515-239-2621

Joseph James Merchant
Principal Investigator

Marshalltown

McFarland Clinic PC-Marshalltown

Joseph James Merchant
Ph: 515-239-2621

Joseph James Merchant
Principal Investigator

Sioux City

Siouxland Regional Cancer Center

Donald B. Wender
Ph: 712-252-0088

Donald B. Wender
Principal Investigator

West Des Moines

Methodist West Hospital

Robert J. Behrens
Ph: 515-282-2921

Robert J. Behrens
Principal Investigator

Kansas
Chanute

Cancer Center of Kansas - Chanute

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Dodge City

Cancer Center of Kansas - Dodge City

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

El Dorado

Cancer Center of Kansas - El Dorado

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Fort Scott

Cancer Center of Kansas - Fort Scott

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Independence

Cancer Center of Kansas-Independence

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Kingman

Cancer Center of Kansas-Kingman

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Lawrence

Lawrence Memorial Hospital

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Liberal

Cancer Center of Kansas-Liberal

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Newton

Cancer Center of Kansas - Newton

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Parsons

Cancer Center of Kansas - Parsons

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Pratt

Cancer Center of Kansas - Pratt

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Salina

Cancer Center of Kansas - Salina

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Wellington

Cancer Center of Kansas - Wellington

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Wichita

Associates In Womens Health

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Cancer Center of Kansas - Main Office

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Cancer Center of Kansas-Wichita Medical Arts Tower

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Via Christi Regional Medical Center

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Winfield

Cancer Center of Kansas - Winfield

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Louisiana
Baton Rouge

Ochsner Health Center-Summa

Jyotsna Fuloria
Ph: 888-562-4763

Jyotsna Fuloria
Principal Investigator

New Orleans

Ochsner Baptist Medical Center

Jyotsna Fuloria
Ph: 888-562-4763

Jyotsna Fuloria
Principal Investigator

Ochsner Medical Center Jefferson

Jyotsna Fuloria
Ph: 888-562-4763

Jyotsna Fuloria
Principal Investigator

Maryland
Baltimore

Greater Baltimore Medical Center

Gary Irvin Cohen
Ph: 443-849-3706

Gary Irvin Cohen
Principal Investigator

Michigan
Adrian

Hickman Cancer Center

Rex B. Mowat
Ph: 800-444-3561

Rex B. Mowat
Principal Investigator

Ann Arbor

Saint Joseph Mercy Hospital

Philip J. Stella
Ph: 734-712-4673

Philip J. Stella
Principal Investigator

Dearborn

Oakwood Hospital and Medical Center

Philip J. Stella
Ph: 734-712-4673

Philip J. Stella
Principal Investigator

Detroit

Saint John Hospital and Medical Center

Philip J. Stella
Ph: 734-712-4673

Philip J. Stella
Principal Investigator

Escanaba

Green Bay Oncology - Escanaba

Brian Leslie Burnette
Ph: 800-432-6049

Brian Leslie Burnette
Principal Investigator

Flint

Genesys Hurley Cancer Institute

Philip J. Stella
Ph: 734-712-4673

Philip J. Stella
Principal Investigator

Hurley Medical Center

Philip J. Stella
Ph: 734-712-4673

Philip J. Stella
Principal Investigator

Iron Mountain

Green Bay Oncology - Iron Mountain

Brian Leslie Burnette
Ph: 800-432-6049

Brian Leslie Burnette
Principal Investigator

Jackson

Allegiance Health

Philip J. Stella
Ph: 734-712-4673

Philip J. Stella
Principal Investigator

Lansing

Sparrow Hospital

Philip J. Stella
Ph: 734-712-4673

Philip J. Stella
Principal Investigator

Livonia

Saint Mary Mercy Hospital

Philip J. Stella
Ph: 734-712-4673

Philip J. Stella
Principal Investigator

Monroe

Toledo Clinic Cancer Centers-Monroe

Rex B. Mowat
Ph: 800-444-3561

Rex B. Mowat
Principal Investigator

Port Huron

Saint Joseph Mercy Port Huron

Philip J. Stella
Ph: 734-712-4673

Philip J. Stella
Principal Investigator

Saginaw

Saint Mary's of Michigan

Philip J. Stella
Ph: 734-712-4673

Philip J. Stella
Principal Investigator

Minnesota
Burnsville

Fairview Ridges Hospital

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

Joseph W. Leach
Principal Investigator

Coon Rapids

Mercy Hospital

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

Joseph W. Leach
Principal Investigator

Edina

Fairview-Southdale Hospital

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

Joseph W. Leach
Principal Investigator

Fridley

Unity Hospital

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

Joseph W. Leach
Principal Investigator

Hutchinson

Hutchinson Area Health Care

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

Joseph W. Leach
Principal Investigator

Maplewood

Minnesota Oncology Hematology PA-Maplewood

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

Joseph W. Leach
Principal Investigator

Saint John's Hospital - Healtheast

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

Joseph W. Leach
Principal Investigator

Minneapolis

Abbott-Northwestern Hospital

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

Joseph W. Leach
Principal Investigator

Health Partners Inc

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

Joseph W. Leach
Principal Investigator

Hennepin County Medical Center

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

Joseph W. Leach
Principal Investigator

Robbinsdale

North Memorial Medical Health Center

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

Joseph W. Leach
Principal Investigator

Saint Louis Park

Park Nicollet Clinic - Saint Louis Park

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

Joseph W. Leach
Principal Investigator

Saint Paul

Regions Hospital

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

Joseph W. Leach
Principal Investigator

United Hospital

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

Joseph W. Leach
Principal Investigator

Shakopee

Saint Francis Regional Medical Center

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

Joseph W. Leach
Principal Investigator

Waconia

Ridgeview Medical Center

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

Joseph W. Leach
Principal Investigator

Willmar

Rice Memorial Hospital

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

Joseph W. Leach
Principal Investigator

Woodbury

Minnesota Oncology and Hematology PA-Woodbury

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

Joseph W. Leach
Principal Investigator

Missouri
Bonne Terre

Parkland Health Center-Bonne Terre

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

James Lloyd Wade
Principal Investigator

Cape Girardeau

Saint Francis Medical Center

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

James Lloyd Wade
Principal Investigator

Southeast Cancer Center

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

James Lloyd Wade
Principal Investigator

Jefferson City

Capital Region Medical Center-Goldschmidt Cancer Center

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

James Lloyd Wade
Principal Investigator

Saint Louis

Missouri Baptist Medical Center

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

James Lloyd Wade
Principal Investigator

Sainte Genevieve

Sainte Genevieve County Memorial Hospital

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

James Lloyd Wade
Principal Investigator

Sullivan

Missouri Baptist Sullivan Hospital

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

James Lloyd Wade
Principal Investigator

Sunset Hills

Missouri Baptist Outpatient Center-Sunset Hills

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

James Lloyd Wade
Principal Investigator

New Jersey
New Brunswick

Rutgers Cancer Institute of New Jersey

Janice M. Mehnert
Ph: 732-235-8675

Janice M. Mehnert
Principal Investigator

New York
Stony Brook

Stony Brook University Medical Center

Andrzej P. Kudelka
Ph: 800-862-2215

Andrzej P. Kudelka
Principal Investigator

Ohio
Akron

Summa Akron City Hospital/Cooper Cancer Center

Jennifer Eileen Payne
Ph: 330-375-6101

Jennifer Eileen Payne
Principal Investigator

Belpre

Strecker Cancer Center-Belpre

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

Chillicothe

Adena Regional Medical Center

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

Columbus

Columbus Oncology and Hematology Associates Inc

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

Doctors Hospital

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

Grant Medical Center

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

Mount Carmel Health Center West

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

Riverside Methodist Hospital

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

The Mark H Zangmeister Center

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

Delaware

Delaware Health Center-Grady Cancer Center

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

Delaware Radiation Oncology

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

Grady Memorial Hospital

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

Lancaster

Fairfield Medical Center

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

Marietta

Marietta Memorial Hospital

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

Maumee

Toledo Clinic Cancer Centers-Maumee

Rex B. Mowat
Ph: 800-444-3561

Rex B. Mowat
Principal Investigator

Mount Vernon

Knox Community Hospital

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

Newark

Licking Memorial Hospital

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

Newark Radiation Oncology

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

Oregon

Saint Charles Hospital

Rex B. Mowat
Ph: 800-444-3561

Rex B. Mowat
Principal Investigator

Portsmouth

Southern Ohio Medical Center

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

Toledo

Mercy Saint Anne Hospital

Rex B. Mowat
Ph: 800-444-3561

Rex B. Mowat
Principal Investigator

Toledo Clinic Cancer Centers-Toledo

Rex B. Mowat
Ph: 800-444-3561

Rex B. Mowat
Principal Investigator

Westerville

Saint Ann's Hospital

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

Zanesville

Genesis HealthCare System

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

John Philip Kuebler
Principal Investigator

Pennsylvania
Danville

Geisinger Medical Center

Christian S. Adonizio
Ph: 570-271-5251

Christian S. Adonizio
Principal Investigator

Hazleton

Geisinger Medical Center-Cancer Center Hazleton

Christian S. Adonizio
Ph: 570-271-5251

Christian S. Adonizio
Principal Investigator

Lewisburg

Geisinger Medical Oncology at Evangelical Community Hospital

Christian S. Adonizio
Ph: 570-271-5251

Christian S. Adonizio
Principal Investigator

Lewistown

Lewistown Hospital

Christian S. Adonizio
Ph: 570-271-5251

Christian S. Adonizio
Principal Investigator

Philadelphia

Fox Chase Cancer Center

Anthony J. Olszanski
Ph: 215-728-4790

Anthony J. Olszanski
Principal Investigator

Pittsburgh

University of Pittsburgh Cancer Institute (UPCI)

Ahmad A. Tarhini
Ph: 412-647-8073

Ahmad A. Tarhini
Principal Investigator

State College

Geisinger Medical Group

Christian S. Adonizio
Ph: 570-271-5251

Christian S. Adonizio
Principal Investigator

Wilkes-Barre

Geisinger Wyoming Valley/Henry Cancer Center

Christian S. Adonizio
Ph: 570-271-5251

Christian S. Adonizio
Principal Investigator

West Virginia
Charleston

West Virginia University Charleston

Steven James Jubelirer
Ph: 304-344-3457

Steven James Jubelirer
Principal Investigator

Wisconsin
Burlington

Aurora Cancer Care-Burlington

Rubina Qamar
Ph: 888-709-2080

Rubina Qamar
Principal Investigator

Elkhorn

Aurora Cancer Care-Southern Lakes

Rubina Qamar
Ph: 888-709-2080

Rubina Qamar
Principal Investigator

Fond Du Lac

Aurora Health Center-Fond du Lac

Dhimant R. Patel
Ph: 800-252-2990

Dhimant R. Patel
Principal Investigator

Grafton

Aurora Cancer Care-Grafton

Rubina Qamar
Ph: 888-709-2080

Rubina Qamar
Principal Investigator

Green Bay

Aurora BayCare Medical Center

Dhimant R. Patel
Ph: 800-252-2990

Dhimant R. Patel
Principal Investigator

Green Bay Oncology at Saint Vincent Hospital

Brian Leslie Burnette
Ph: 800-432-6049

Brian Leslie Burnette
Principal Investigator

Green Bay Oncology Limited at Saint Mary's Hospital

Brian Leslie Burnette
Ph: 800-432-6049

Brian Leslie Burnette
Principal Investigator

Saint Mary's Hospital

Brian Leslie Burnette
Ph: 800-432-6049

Brian Leslie Burnette
Principal Investigator

Saint Vincent Hospital

Brian Leslie Burnette
Ph: 800-432-6049

Brian Leslie Burnette
Principal Investigator

Johnson Creek

UW Cancer Center Johnson Creek

Mark Richard Albertini
Ph: 877-405-6866

Mark Richard Albertini
Principal Investigator

Kenosha

Aurora Cancer Care-Kenosha South

Rubina Qamar
Ph: 888-709-2080

Rubina Qamar
Principal Investigator

La Crosse

Gundersen Lutheran Medical Center

Kurt Oettel
Ph: 608-775-2385
Email: cancerctr@gundluth.org

Kurt Oettel
Principal Investigator

Madison

University of Wisconsin Hospital and Clinics

Mark Richard Albertini
Ph: 877-405-6866

Mark Richard Albertini
Principal Investigator

Manitowoc

Holy Family Memorial Hospital

Brian Leslie Burnette
Ph: 800-432-6049

Brian Leslie Burnette
Principal Investigator

Marinette

Bay Area Medical Center

Brian Leslie Burnette
Ph: 800-432-6049

Brian Leslie Burnette
Principal Investigator

Vince Lombardi Cancer Clinic-Marinette

Dhimant R. Patel
Ph: 800-252-2990

Dhimant R. Patel
Principal Investigator

Menomonee Falls

Aurora Advanced Healthcare Inc-Menomonee Falls

Rubina Qamar
Ph: 888-709-2080

Rubina Qamar
Principal Investigator

Milwaukee

Aurora Cancer Care-Milwaukee

Rubina Qamar
Ph: 888-709-2080

Rubina Qamar
Principal Investigator

Aurora Saint Luke's Medical Center

Rubina Qamar
Ph: 888-709-2080

Rubina Qamar
Principal Investigator

Aurora Sinai Medical Center

Rubina Qamar
Ph: 888-709-2080

Rubina Qamar
Principal Investigator

Froedtert and the Medical College of Wisconsin

Stuart J. Wong
Ph: 414-805-4380

Stuart J. Wong
Principal Investigator

Wheaton Franciscan Healthcare - Saint Joseph

Jonathan Scott Treisman
Ph: 414-427-2360

Jonathan Scott Treisman
Principal Investigator

New Richmond

Cancer Center of Western Wisconsin

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

Joseph W. Leach
Principal Investigator

Oconto Falls

Green Bay Oncology - Oconto Falls

Brian Leslie Burnette
Ph: 800-432-6049

Brian Leslie Burnette
Principal Investigator

Oshkosh

Vince Lombardi Cancer Clinic - Oshkosh

Dhimant R. Patel
Ph: 800-252-2990

Dhimant R. Patel
Principal Investigator

Racine

Aurora Cancer Care-Racine

Rubina Qamar
Ph: 888-709-2080

Rubina Qamar
Principal Investigator

Sheboygan

Saint Nicholas Hospital

Brian Leslie Burnette
Ph: 800-432-6049

Brian Leslie Burnette
Principal Investigator

Vince Lombardi Cancer Clinic-Sheboygan

Dhimant R. Patel
Ph: 800-252-2990

Dhimant R. Patel
Principal Investigator

Sturgeon Bay

Green Bay Oncology - Sturgeon Bay

Brian Leslie Burnette
Ph: 800-432-6049

Brian Leslie Burnette
Principal Investigator

Summit

Aurora Medical Center in Summit

Dhimant R. Patel
Ph: 800-252-2990

Dhimant R. Patel
Principal Investigator

Two Rivers

Vince Lombardi Cancer Clinic

Dhimant R. Patel
Ph: 800-252-2990

Dhimant R. Patel
Principal Investigator

Waukesha

Aurora Cancer Care-Waukesha

Rubina Qamar
Ph: 888-709-2080

Rubina Qamar
Principal Investigator

Wauwatosa

Aurora Cancer Care-Milwaukee West

Rubina Qamar
Ph: 888-709-2080

Rubina Qamar
Principal Investigator

West Allis

Aurora West Allis Medical Center

Rubina Qamar
Ph: 888-709-2080

Rubina Qamar
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01708941

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.