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

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIBiomarker/Laboratory analysis, TreatmentActive18 and overNCINCI-2012-01932
CDR0000741878, ECOG-E3611, E3611, U10CA180820, 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, 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 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
  • 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
  • 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; 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
  • 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 Tarhini, Principal Investigator

    Trial Sites

    U.S.A.

    Alabama
    Birmingham

    UAB Comprehensive Cancer Center

    Robert M Conry
    Ph: 205-934-0309

    Connecticut
    Hartford

    Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

    Philip J. Stella
    Ph: 734-712-4673

    Delaware
    Lewes

    Tunnell Cancer Center at Beebe Medical Center

    Gregory A. Masters
    Ph: 302-733-6227

    Newark

    Christiana Gynecologic Oncology, LLC

    Gregory A. Masters
    Ph: 302-733-6227

    Delaware Clinical and Laboratory Physicians

    Gregory A. Masters
    Ph: 302-733-6227

    Helen F. Graham Cancer Center at Christiana Hospital

    Gregory A. Masters
    Ph: 302-733-6227

    Gregory A. Masters
    Ph: 302-733-6227

    Medical Oncology Hematology Consultants, PA at Helen F. Graham Cancer Center

    Gregory A. Masters
    Ph: 302-733-6227

    Regional Hematology/Oncology, PA - Newark

    Gregory A. Masters
    Ph: 302-733-6227

    Rehoboth Beach

    Beebe Health Campus

    Gregory A. Masters
    Ph: 302-733-6227

    Seaford

    Nanticoke Memorial Hospital

    Gregory A. Masters
    Ph: 302-733-6227

    Wilmington

    Christiana Care Health System-Wilmington 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: 734-712-4673

    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

    Centralia

    Centralia Oncology Clinic

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

    Chicago

    Robert H. Lurie Comprehensive Cancer Center at Northwestern University

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

    Danville

    Carle on Vermilion

    James R Egner
    Ph: 800-446-5532

    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

    Carle Physician Group-Effingham

    James R Egner
    Ph: 800-446-5532

    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

    InterCommunity Cancer Center of Western Illinois

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

    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

    Highland Park

    Hematology Oncology Associates of Illinois-Highland Park

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

    Libertyville

    North Shore Oncology and Hematology Associates, Limited - Libertyville

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

    Macomb

    Illinois CancerCare - Macomb

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

    Mattoon

    Carle Physician Group-Mattoon/Charleston

    James R Egner
    Ph: 800-446-5532

    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

    Niles

    Cancer Care and Hematology Specialists of Chicagoland - Niles

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

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

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

    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

    Valley Cancer Center

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

    Rockford

    Advanced Care and Treatment Medical Group, PC

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

    Skokie

    Hematology Oncology Associates - Skokie

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

    Springfield

    Central Illinois Hematology Oncology Center

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

    Regional Cancer Center at Memorial Medical Center

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

    Simmons Cooper Cancer Institute

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

    Springfield Clinic - Main Campus

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

    Urbana

    Carle Cancer Center at Carle Foundation Hospital

    James R Egner
    Ph: 800-446-5532

    James R Egner
    Ph: 800-446-5532

    Yorkville

    Rush-Copley Healthcare Center

    James R Egner
    Ph: 800-446-5532

    Indiana
    Michigan City

    Saint Anthony Memorial Health Centers

    James R Egner
    Ph: 800-446-5532

    Woodland Cancer Care Center

    James R Egner
    Ph: 800-446-5532

    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

    Des Moines

    John Stoddard Cancer Center at Iowa Lutheran Hospital

    Robert J Behrens
    Ph: 515-282-2921

    John Stoddard Cancer Center at Iowa Methodist Medical Center

    Robert J Behrens
    Ph: 515-282-2921

    Medical Oncology and Hematology Associates at John Stoddard Cancer Center

    Robert J Behrens
    Ph: 515-282-2921

    Fort Dodge

    Trinity Regional Medical Center

    Joseph James Merchant
    Ph: 515-239-2621

    Jefferson

    McFarland Clinic PC-Jefferson

    Joseph James Merchant
    Ph: 515-239-2621

    Marshalltown

    McFarland Clinic PC-Marshalltown

    Joseph James Merchant
    Ph: 515-239-2621

    Sioux City

    Siouxland Hematology-Oncology Associates, LLP

    Donald Bruce Wender
    Ph: 712-252-0088

    West Des Moines

    Methodist West Hospital

    Robert J Behrens
    Ph: 515-282-2921

    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

    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

    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: 800-444-3561

    Ann Arbor

    Saint Joseph Mercy Cancer Center

    Philip J. Stella
    Ph: 734-712-4673

    Dearborn

    Oakwood Cancer Center at Oakwood Hospital and Medical Center

    Philip J. Stella
    Ph: 734-712-4673

    Detroit

    Van Elslander Cancer Center at St. John Hospital and Medical Center

    Philip J. Stella
    Ph: 734-712-4673

    Escanaba

    Green Bay Oncology, Limited - Escanaba

    Brian L Burnette
    Ph: 800-432-6049

    Flint

    Genesys Hurley Cancer Institute

    Philip J. Stella
    Ph: 734-712-4673

    Hurley Medical Center

    Philip J. Stella
    Ph: 734-712-4673

    Iron Mountain

    Green Bay Oncology - Iron Mountain

    Brian L Burnette
    Ph: 800-432-6049

    Jackson

    Gayle M. Jacob Cancer Center at Allegiance Health

    Philip J. Stella
    Ph: 734-712-4673

    Lansing

    Sparrow Regional Cancer Center

    Philip J. Stella
    Ph: 734-712-4673

    Livonia

    St. Mary Mercy Hospital

    Philip J. Stella
    Ph: 734-712-4673

    Monroe

    Community Cancer Center of Monroe

    Rex B Mowat
    Ph: 800-444-3561

    Port Huron

    Mercy Regional Cancer Center at Mercy Hospital

    Philip J. Stella
    Ph: 734-712-4673

    Saginaw

    Seton Cancer Institute at Saint Mary's - Saginaw

    Philip J. Stella
    Ph: 734-712-4673

    Minnesota
    Burnsville

    Fairview Ridges Hospital

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

    Coon Rapids

    Mercy and Unity Cancer Center at Mercy Hospital

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

    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

    Health Partners Inc

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

    Hennepin County Medical Center - Minneapolis

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

    Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

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

    Robbinsdale

    Humphrey Cancer Center at North Memorial Outpatient Center

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

    Saint Louis Park

    Park Nicollet Cancer Center

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

    Saint Paul

    Regions Hospital Cancer Care Center

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

    United Hospital

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

    Shakopee

    St. Francis Cancer Center at St. Francis Medical Center

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

    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
    Bonne Terre

    Parkland Health Center-Bonne Terre

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

    Cape Girardeau

    Saint Francis Medical Center

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

    Southeast Cancer Center

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

    Jefferson City

    Goldschmidt Cancer Center

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

    Saint Louis

    Missouri Baptist Cancer Center

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

    Sainte Genevieve

    Sainte Genevieve County Memorial Hospital

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

    Sullivan

    Missouri Baptist Sullivan Hospital

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

    Sunset Hills

    Missouri Baptist Outpatient Center-Sunset Hills

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

    Nebraska
    Lincoln

    Nebraska Hematology and Oncology

    Gamini S. Soori
    Ph: 402-991-8070ext202
    Email: mwilwerding@mvcc.cc

    Southeast Nebraska Hematology Oncology Consultants at Southeast Nebraska Cancer Center

    Gamini S. Soori
    Ph: 402-991-8070
    Email: mwilwerding@mvcc.cc

    Omaha

    Oncology Hematology West PC

    Gamini S. Soori
    Ph: 402-991-8070ext202
    Email: mwilwerding@mvcc.cc

    Oncology Hematology West, PC - Omaha Bergan

    Gamini S. Soori
    Ph: 402-991-8070ext202
    Email: mwilwerding@mvcc.cc

    Scottsbluff

    Cancer Treatment Center at Regional West Medical Center

    Gamini S. Soori
    Ph: 402-991-8070ext202
    Email: mwilwerding@mvcc.cc

    New Jersey
    East Orange

    Veterans Affairs Medical Center - East Orange

    Victor T Chang
    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
    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: 614-566-3275

    Chillicothe

    Adena Regional Medical Center

    J. Philip Kuebler
    Ph: 614-566-3275

    Columbus

    Columbus Oncology Associates, Incorporated

    J. Philip Kuebler
    Ph: 614-566-3275

    Doctors Hospital at Ohio Health

    J. Philip Kuebler
    Ph: 614-566-3275

    Grant Medical Center Cancer Care

    J. Philip Kuebler
    Ph: 614-566-3275

    Mount Carmel Health - West Hospital

    J. Philip Kuebler
    Ph: 614-566-3275

    Riverside Methodist Hospital Cancer Care

    J. Philip Kuebler
    Ph: 614-566-3275

    Zangmeister Center

    J. Philip Kuebler
    Ph: 614-566-3275

    Delaware

    Delaware Health Center

    J. Philip Kuebler
    Ph: 614-566-3275

    Delaware Radiation Oncology

    J. Philip Kuebler
    Ph: 614-566-3275

    Grady Memorial Hospital

    J. Philip Kuebler
    Ph: 614-566-3275

    Lancaster

    Fairfield Medical Center

    J. Philip Kuebler
    Ph: 614-566-3275

    Marietta

    Strecker Cancer Center at Marietta Memorial Hospital

    J. Philip Kuebler
    Ph: 614-566-3275

    Maumee

    Northwest Ohio Oncology Center

    Rex B Mowat
    Ph: 800-444-3561

    Mount Vernon

    Knox Community Hospital

    J. Philip Kuebler
    Ph: 614-566-3275

    Newark

    Licking Memorial Cancer Care Program at Licking Memorial Hospital

    J. Philip Kuebler
    Ph: 614-566-3275

    Newark Radiation Oncology

    J. Philip Kuebler
    Ph: 614-566-3275

    Oregon

    St. Charles Mercy Hospital

    Rex B Mowat
    Ph: 800-444-3561

    Portsmouth

    Southern Ohio Medical Center Cancer Center

    J. Philip Kuebler
    Ph: 614-566-3275

    Springfield

    Community Hospital of Springfield and Clark County

    J. Philip Kuebler
    Ph: 614-566-3275

    Toledo

    St. Anne Mercy Hospital

    Rex B Mowat
    Ph: 800-444-3561

    Toledo Clinic, Incorporated - Main Clinic

    Rex B Mowat
    Ph: 800-444-3561

    Westerville

    Mount Carmel St. Ann's Cancer Center

    J. Philip Kuebler
    Ph: 614-566-3275

    Zanesville

    Genesis - Good Samaritan Hospital

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

    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

    Lewisburg

    Geisinger Medical Oncology at Evangelical Community Hospital

    Christian Adonizio
    Ph: 570-271-5251

    Lewistown

    Lewistown Hospital

    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

    West Virginia
    Charleston

    West Virginia University Medical School - Charleston

    Steven J. Jubelirer
    Ph: 304-344-3457

    Wisconsin
    Burlington

    Aurora Cancer Care-Burlington

    Rubina Qamar
    Ph: 888-709-2080

    Elkhorn

    Vince Lombardi Cancer Center at Aurora Lakeland Medical Center - Elkhorn

    Rubina Qamar
    Ph: 888-709-2080

    Fond Du Lac

    Aurora Health Center-Fond du Lac

    Dhimant R. Patel
    Ph: 800-252-2990

    Grafton

    Aurora Cancer Care-Grafton

    Rubina Qamar
    Ph: 888-709-2080

    Green Bay

    Green Bay Oncology, Limited at St. Mary's Hospital

    Brian L Burnette
    Ph: 800-432-6049

    Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center

    Brian L Burnette
    Ph: 800-432-6049

    St. Mary's Hospital Medical Center - Green Bay

    Brian L Burnette
    Ph: 800-432-6049

    St. Vincent Hospital Regional Cancer Center

    Brian L Burnette
    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

    Kenosha

    Oncology Alliance - Kenosha South

    Rubina Qamar
    Ph: 888-709-2080

    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

    Brian L Burnette
    Ph: 800-432-6049

    Marinette

    Bay Area Cancer Care Center at Bay Area Medical Center

    Brian L Burnette
    Ph: 800-432-6049

    Vince Lombardi Cancer Clinic - Marinette

    Dhimant R. Patel
    Ph: 800-252-2990

    Menomonee Falls

    Aurora Advanced Healthcare Inc-Menomonee Falls

    Rubina Qamar
    Ph: 888-709-2080

    Milwaukee

    Aurora Cancer Care-Milwaukee

    Rubina Qamar
    Ph: 888-709-2080

    Aurora Sinai Medical Center

    Rubina Qamar
    Ph: 888-709-2080

    Froedtert Hospital and Medical College of Wisconsin

    Stuart J. Wong
    Ph: 414-805-4380

    Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center

    Rubina Qamar
    Ph: 888-709-2080

    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

    Brian L Burnette
    Ph: 800-432-6049

    Oshkosh

    Vince Lombardi Cancer Clinic - Oshkosh

    Dhimant R. Patel
    Ph: 800-252-2990

    Racine

    Aurora Health Center - Racine

    Rubina Qamar
    Ph: 888-709-2080

    Sheboygan

    Saint Nicholas Hospital

    Brian L Burnette
    Ph: 800-432-6049

    Vince Lombardi Cancer Clinic - Sheboygan

    Dhimant R. Patel
    Ph: 800-252-2990

    Sturgeon Bay

    Green Bay Oncology, Limited - Sturgeon Bay

    Brian L Burnette
    Ph: 800-432-6049

    Summit

    Aurora Medical Center

    Dhimant R. Patel
    Ph: 800-252-2990

    Two Rivers

    Vince Lombardi Cancer Clinic - Two Rivers

    Dhimant R. Patel
    Ph: 800-252-2990

    Waukesha

    Aurora Cancer Care-Waukesha

    Rubina Qamar
    Ph: 888-709-2080

    Wauwatosa

    Oncology Alliance, SC - Milwaukee - West

    Rubina Qamar
    Ph: 888-709-2080

    West Allis

    Aurora Women's Pavilion of West Allis Memorial Hospital

    Rubina Qamar
    Ph: 888-709-2080

    Link to the current ClinicalTrials.gov record.
    NLM Identifier NCT01708941
    ClinicalTrials.gov processed this data on May 11, 2015

    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.