Ipilimumab or High-Dose Interferon Alfa-2b in Treating Patients with High-Risk Stage III-IV Melanoma That Has Been Removed by Surgery

  • Resize font
  • Print
  • Email
  • Facebook
  • Twitter
  • Google+
  • Pinterest

Basic Trial Information

PhaseTypeAgeTrial IDs
Phase IIIBiomarker/Laboratory analysis, Treatment18 and overE1609
NCI-2011-02649, CDR0000692568, ECOG-E1609, NCT01274338

Trial Description

Summary

This randomized phase III trial studies ipilimumab to see how well it works compared to high-dose interferon alfa-2b in treating patients with high-risk stage III-IV melanoma that has been removed by surgery. Monoclonal antibodies, such as ipilimumab, may interfere with the ability of tumor cells to grow and spread. Interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of melanoma and other cancers. It is not yet known whether ipilimumab is more effective than interferon alfa-2b in treating patients with melanoma.

Further Study Information

PRIMARY OBJECTIVES:

I. To evaluate recurrence-free survival (RFS) between patients randomized to receive post-operative adjuvant ipilimumab given at either 10 mg/kg (high dose ipilimumab; HIP) or 3 mg/kg (low dose ipilimumab: LIP) versus those randomized to receive high-dose interferon alfa-2b (HDI) utilizing a hierarchical design assessing HIP versus HDI first and LIP versus HDI second (if the first comparison is significant).

II. To evaluate overall survival (OS) between patients randomized to receive post-operative adjuvant ipilimumab given at either 10 mg/kg (HIP) or 3 mg/kg (LIP) versus those randomized to receive HDI utilizing a hierarchical design assessing HIP versus HDI first and LIP versus HDI second (if the first comparison is significant).

SECONDARY OBJECTIVES:

I. To evaluate safety and tolerability of post-operative adjuvant ipilimumab therapy given at either 10 mg/kg (HIP) or 3 mg/kg (LIP).

II. Among patients enrolled by Clinical Community Oncology programs (CCOPs), to compare the global quality of life (QOL) between the ipilimumab arms versus HDI using Functional Assessment of Cancer Therapy (FACT)-General (G) form and to evaluate the effect of treatment-related side effects that may have an impact on the health-related domains of QOL using Functional Assessment of Chronic Illness Therapy (FACIT)-diarrhea (D) and FACT-biological response modifiers (BRM).

OUTLINE: Patients age >= 18 are randomized to Arms A, B, or C and patients ages 12-17 are randomized to Arms D, E, or F.

ARM A: Patients receive induction high-dose ipilimumab intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 90 days for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity. (closed accrual as of 4/4/14) (adult accrual has completed to Arms A, B, and C as of 8/15/2014)

ARM B: Patients receive induction high-dose recombinant interferon alfa-2b IV over 20 minutes on days 1-5, 8-12, 15-19, and 22-26 in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance high-dose recombinant interferon alfa-2b subcutaneously (SC) on days 1, 3, and 5. Treatment repeats every week for 48 weeks in the absence of disease progression or unacceptable toxicity. (adult accrual has completed to Arms A, B, and C as of 8/15/2014)

ARM C: Patients receive induction low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 90 days for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity. (adult accrual has completed to Arms A, B, and C as of 8/15/2014)

ARM D: Patients receive induction high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 90 days for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.

ARM E: Patients receive induction high-dose recombinant interferon alfa-2b IV over 20 minutes on days 1-5, 8-12, 15-19, and 22-26 in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance high-dose recombinant interferon alfa-2b SC on days 1, 3, and 5. Treatment repeats every week for 48 weeks in the absence of disease progression or unacceptable toxicity

ARM F: Patients receive induction low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 90 days for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then yearly for up to 15 years.

Eligibility Criteria

Inclusion Criteria:

Patients must have primary cutaneous melanoma that belong to one of the following American Joint Commission on Cancer (AJCC) stages (2009 AJCC Melanoma Staging System):

Stage IIIB

  • T1-4b N1a M0
  • T1-4b N2a M0
  • T1-4b N1b M0
  • T1-4b N2b M0
  • T1-4b N2c M0

Stage IIIC

  • T1-4b N1b M0
  • T1-4b N2b M0
  • T1-4b N2c M0
  • Any T N3 M0

Stage IV

  • M1a
  • M1b
  • NOTE: patients with stage IV melanoma must have normal lactate dehydrogenase (LDH) and either distant skin, subcutaneous, lymph node, or lung metastases, but no other visceral metastases in order to be eligible; for patients with resected stage IV melanoma, LDH within the institutional upper limit of normal (ULN) must be documented within 4 weeks prior to randomization

Patients with unknown primary melanoma (Tx) who present with cutaneous, subcutaneous, nodal and/or lung metastases that are completely surgically resected with free margins are allowed; these patients are allowed even if they don’t fit the strict staging criteria; for stage IV patients LDH within the institutional ULN must be documented within 4 weeks prior to randomization (M1c is not eligible)

NOTE: all subjects should be classified as IIIB, IIIC, M1a or M1b including subjects with disease recurrence after adequate surgical excision of the original primary melanoma; that is the treating team/physician investigator should review an overall TNM status (that includes primary tumor presentation and disease recurrence status) and provide a designation of IIIB, IIIC, M1a or M1b

Serum bilirubin =< 1.5 x ULN, (except patients with Gilbert’s syndrome, who must have a total bilirubin less than 3.0 mg/dL)

Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x ULN

WOCBP must be using an adequate method of contraception to avoid 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; 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 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

WOCBP are not eligible if they satisfy any of the following:

  • A positive pregnancy test at baseline
  • Pregnant or breastfeeding

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: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months); post-menopause is defined as:

  • Amenorrhea >= 12 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

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 (i.e., 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, Sjögren'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 received any adjuvant treatment (chemotherapy, biotherapy, or limb perfusion) after the resection(s) that make(s) them eligible for this trial

NOTE: previous radiation therapy, including after the surgical resection, is allowed as long as 21 days have elapsed between the radiation and initiation of this adjuvant systemic therapy

Patients must be randomized within 84 days (12 weeks) of surgical resection; if more than one surgical procedure is required to render the patient disease-free, the patient must be randomized within 12 weeks of the last surgery

NOTE: patients with clinically positive lymph nodes for melanoma involvement or those with positive lymph nodes identified through lymphoscintigraphic and/or dye lymphographic techniques in the groin, axilla, or neck should have additional lymphadenectomy in those sites; the complete lymph node dissection procedure would be considered as the last surgery in counting the 84 days unless a subsequent surgical procedure(s) was clinically required to ensure the disease free status

Absolute neutrophil count (ANC) >= 1,500/uL

Platelets >= 100 x 10^3/uL

White blood cell (WBC) >= 3,000/uL

Hemoglobin >= 10 g/dL

Patients must not be prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness

Patients must not have had any infectious disease vaccination (e.g., standard influenza, H1N1 influenza, pneumococcal, meningococcal, or tetanus toxoid) within 4 weeks prior to randomization

No active or chronic infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; patients must have negative testing for HIV, hepatitis B virus (HBV), hepatitis C virus (HCV) within 4 weeks prior to randomization

Serum creatinine =< 1.5 mg/dL

Patients must not have an active infection requiring current treatment with parenteral antibiotics

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; 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 melanoma in situ are eligible; patients with prior history of basal or squamous skin cancer are eligible; patients who have had multiple primary melanomas are eligible

Patients must not have a documented history of inflammatory bowel disease (including ulcerative colitis and Crohn’s disease) or diverticulitis (history of diverticulosis is allowed)

Patients with disease recurrence after adequate surgical excision of the original primary cutaneous/unknown primary melanoma are allowed even if they don’t fit the strict staging criteria, but only as follows:

Recurrence in a regional lymph node basin after a prior complete lymph node dissection; relapsed disease must be completely surgically resected with free margins

Recurrence in the form of in-transit or satellite metastases or distant skin/subcutaneous, nodal, or lung metastases that are completely surgically resected with free margins

Recurrence in a regional lymph node basin; relapsed disease must be completely surgically resected with free margins

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

Patients should be carefully screened for depression at baseline and if there are indications or a history of depression it is strongly recommended that these patients be closely followed together with behavioral health or psychiatric medical support; patients with an established diagnosis of depression that, in the assessment of the investigator may make the administration of interferon (IFN)-alfa or ipilimumab hazardous, should not be enrolled on this protocol; the risks and benefits of being treated with standard adjuvant IFN-alfa should be weighed very carefully in consultation with behavioral health or psychiatry

All patients must have disease-free status documented by a complete physical examination and imaging studies within 4 weeks prior to randomization; imaging studies must include a total body positron emission tomography (PET)-computed tomography (CT) scan (with or without brain) and brain magnetic resonance imaging (MRI) or CT (if MRI is contraindicated); if PET-CT cannot be done, CT of neck, chest, abdomen, and pelvis should be done

If for some reason a CT cannot be done, an MRI may be done instead; any other imaging studies if performed (eg, bone scan) must show no evidence of disease

Prior treatment with anti-cytotoxic T-lymphocyte antigen 4 (CTLA4) monoclonal antibodies or prior CTLA-4 inhibitor or agonist or prior clusters of differentiation (CD)137 agonist or prior interferon-alfa is not allowed; other forms of prior treatment for melanoma (e.g., aldesleukin [IL-2], anti-tumor vaccine, chemotherapy) are allowed if given before the resection(s) that make(s) the patient eligible for this trial, but these must have been completed at least 4 weeks prior to randomization

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 with a baseline of frequent diarrhea (e.g. irritable bowel syndrome) are not eligible

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

National Cancer Institute

  • National Cancer Institute
Ahmad A. Tarhini, Principal Investigator

Trial Sites

U.S.A.

Arizona
Tucson

The University of Arizona Medical Center-University Campus

Joanne M. Jeter
Ph: 520-626-9008

Joanne M. Jeter
Principal Investigator

California
Los Angeles

Mattel Children's Hospital UCLA

Bartosz Chmielowski
Ph: 888-798-0719

Bartosz Chmielowski
Principal Investigator

Oakland

Kaiser Permanente-Oakland

Louis Fehrenbacher
Ph: 626-564-3455

Louis Fehrenbacher
Principal Investigator

Sacramento

Sutter General Hospital

Deepti Behl
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Deepti Behl
Principal Investigator

District of Columbia
Washington

MedStar Georgetown University Hospital

Michael B. Atkins
Ph: 202-444-0381

Michael B. Atkins
Principal Investigator

Florida
Gainesville

University of Florida

Stephen Paul Staal
Ph: 352-273-8675
Email: trials@cancer.ufl.edu

Stephen Paul Staal
Principal Investigator

Miami

University of Miami Miller School of Medicine-Sylvester Cancer Center

Mecker G. Moller
Ph: 866-574-5124
Email: Sylvester@emergingmed.com

Mecker G. Moller
Principal Investigator

Stuart

Martin Hospital South

Guillermo Abesada-Terk
Ph: 772-288-5858ext4

Guillermo Abesada-Terk
Principal Investigator

Martin Medical Center

Guillermo Abesada-Terk
Ph: 772-288-5858ext4

Guillermo Abesada-Terk
Principal Investigator

Robert and Carol Weissman Cancer Center at Martin Health

Guillermo Abesada-Terk
Ph: 772-288-5858ext4

Guillermo Abesada-Terk
Principal Investigator

Georgia
Atlanta

Atlanta Regional CCOP

Thomas Edwin Seay
Ph: 404-303-3355

Thomas Edwin Seay
Principal Investigator

Augusta

Georgia Regents University Medical Center

Sharad Anant Ghamande
Ph: 706-721-1663
Email: cancer@georgiahealth.edu

Sharad Anant Ghamande
Principal Investigator

Columbus

John B Amos Cancer Center

Thomas Edwin Seay
Ph: 404-303-3355

Thomas Edwin Seay
Principal Investigator

Hawaii
Honolulu

Kapiolani Medical Center for Women and Children

Jeffrey L. Berenberg
Ph: 808-586-2979

Jeffrey L. Berenberg
Principal Investigator

Idaho
Boise

Saint Luke's Mountain States Tumor Institute

Paul G. Montgomery
Ph: 800-845-4624

Paul G. Montgomery
Principal Investigator

Illinois
Galesburg

Illinois CancerCare-Galesburg Cottage Plaza Office

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

Nguyet Anh Le-Lindqwister
Principal Investigator

Maywood

Loyola University Medical Center

Joseph I. Clark
Ph: 708-226-4357

Joseph I. Clark
Principal Investigator

Springfield

Southern Illinois University School of Medicine

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

James Lloyd Wade
Principal Investigator

Urbana

Carle Clinic-Urbana Main

Adam Irwin Riker
Ph: 800-323-8622

Adam Irwin Riker
Principal Investigator

Iowa
Iowa City

University of Iowa/Holden Comprehensive Cancer Center

Mohammed M. Milhem
Ph: 800-237-1225

Mohammed M. Milhem
Principal Investigator

Kansas
Shawnee Mission

Kansas City Cancer Center-Shawnee Mission

Peter J. Van Veldhuizen
Ph: 800-525-1483

Peter J. Van Veldhuizen
Principal Investigator

Louisiana
New Orleans

Ochsner Medical Center Jefferson

Jyotsna Fuloria
Ph: 888-562-4763

Jyotsna Fuloria
Principal Investigator

Maryland
Baltimore

Sinai Hospital of Baltimore

Mukund S. Didolkar
Ph: 410-601-6120
Email: pridgely@lifebridgehealth.org

Mukund S. Didolkar
Principal Investigator

Massachusetts
Boston

Dana-Farber Cancer Institute

Frank Stephen Hodi
Ph: 877-442-3324

Frank Stephen Hodi
Principal Investigator

Massachusetts General Hospital Cancer Center

Frank Stephen Hodi
Ph: 877-442-3324

Frank Stephen Hodi
Principal Investigator

Springfield

Baystate Medical Center

John Charles McCann
Ph: 413-794-3565
Email: tamara.wrenn@baystatehealth.org

John Charles McCann
Principal Investigator

Worcester

University of Massachusetts Medical School

William V. Walsh
Ph: 508-856-3216
Email: cancer.research@umassmed.edu

William V. Walsh
Principal Investigator

Michigan
Ann Arbor

University of Michigan Comprehensive Cancer Center

Ahmad A. Tarhini
Ph: 412-647-8073
Email: tarhiniaa@upmc.edu

Ahmad A. Tarhini
Principal Investigator

Detroit

Saint John Hospital and Medical Center

Philip J. Stella
Ph: 734-712-4673

Philip J. Stella
Principal Investigator

Wayne State University/Karmanos Cancer Institute

Lawrence E. Flaherty
Ph: 313-576-9363

Lawrence E. Flaherty
Principal Investigator

Flint

Hurley Medical Center

Philip J. Stella
Ph: 734-712-4673

Philip J. Stella
Principal Investigator

Grand Rapids

Spectrum Health at Butterworth Campus

Gilbert D.A. Padula
Ph: 616-685-5225
Email: connie.szczepanek@grcop.org

Gilbert D.A. Padula
Principal Investigator

Kalamazoo

West Michigan Cancer Center

Sunil Nagpal
Ph: 269-373-7458

Sunil Nagpal
Principal Investigator

Missouri
Saint Louis

Mercy Hospital Saint Louis

Jay W. Carlson
Ph: 800-821-7532

Jay W. Carlson
Principal Investigator

Washington University School of Medicine

Gerald P. Linette
Ph: 800-600-3606
Email: info@siteman.wustl.edu

Gerald P. Linette
Principal Investigator

Nebraska
Omaha

Missouri Valley Cancer Consortium

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

Gamini S. Soori
Principal Investigator

Nevada
Las Vegas

Nevada Cancer Research Foundation CCOP

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Summerlin Hospital Medical Center

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

New Hampshire
Lebanon

Dartmouth Hitchcock Medical Center

Marc Stuart Ernstoff
Ph: 866-223-8100

Marc Stuart Ernstoff
Principal Investigator

New Jersey
Hackensack

Hackensack University Medical CCOP

Donna Trauth McNamara
Ph: 201-996-2879

Donna Trauth McNamara
Principal Investigator

Hackensack University Medical Center

Donna Trauth McNamara
Ph: 201-996-2879

Donna Trauth McNamara
Principal Investigator

Morristown

Morristown Medical Center

Eric David Whitman
Ph: 973-971-5900

Eric David Whitman
Principal Investigator

New Mexico
Albuquerque

University of New Mexico

Montaser Shaheen
Ph: 505-272-6972

Montaser Shaheen
Principal Investigator

New York
Glens Falls

Glens Falls Hospital

John Patrick Stoutenburg
Ph: 518-926-6700

John Patrick Stoutenburg
Principal Investigator

Rochester

University of Rochester

Jonathan Willmann Friedberg
Ph: 585-275-5830

Jonathan Willmann Friedberg
Principal Investigator

North Carolina
Asheville

Mission Hospital-Memorial Campus

Christopher H. Chay
Ph: 828-213-4150

Christopher H. Chay
Principal Investigator

Chapel Hill

University of North Carolina at Chapel Hill

Carrie Lee
Ph: 877-668-0683
Email: cancerclinicaltrials@med.unc.edu

Carrie Lee
Principal Investigator

Charlotte

Carolinas Medical Center/Levine Cancer Institute

Asim Amin
Ph: 704-355-2884

Asim Amin
Principal Investigator

Durham

Duke University Medical Center

Jeffrey Crawford
Ph: 888-275-3853

Jeffrey Crawford
Principal Investigator

Greenville

East Carolina University

Prashanti Atluri
Ph: 252-744-2161

Prashanti Atluri
Principal Investigator

Rutherfordton

Rutherford Hospital

Charles E. Bowers
Ph: 800-486-5941

Charles E. Bowers
Principal Investigator

Ohio
Cleveland

Cleveland Clinic Foundation

Anjali S. Advani
Ph: 866-223-8100

Anjali S. Advani
Principal Investigator

Oklahoma
Oklahoma City

Mercy Hospital Oklahoma City

Vikki A. Canfield
Ph: 405-271-4272
Email: julie-traylor@ouhsc.edu

Vikki A. Canfield
Principal Investigator

University of Oklahoma Health Sciences Center

Alexandra P. Ikeguchi
Ph: 405-271-4272
Email: julie-traylor@ouhsc.edu

Alexandra P. Ikeguchi
Principal Investigator

Oregon
Portland

Oregon Health and Science University

John T. Vetto
Ph: 503-494-1080
Email: trials@ohsu.edu

John T. Vetto
Principal Investigator

Providence Saint Vincent Medical Center

Keith S. Lanier
Ph: 503-215-6412

Keith S. Lanier
Principal Investigator

Pennsylvania
Bethlehem

Lehigh Valley Hospital - Muhlenberg

Eliot L. Friedman
Ph: 610-402-2273

Eliot L. Friedman
Principal Investigator

Danville

Geisinger Medical Center

Christian S. Adonizio
Ph: 570-271-5251

Christian S. Adonizio
Principal Investigator

South Carolina
Anderson

AnMed Health Hospital

Charles E. Bowers
Ph: 800-486-5941

Charles E. Bowers
Principal Investigator

South Dakota
Sioux Falls

Sanford USD Medical Center - Sioux Falls

Preston D. Steen
Ph: 701-234-6161

Preston D. Steen
Principal Investigator

Tennessee
Nashville

Vanderbilt University/Ingram Cancer Center

Igor Puzanov
Ph: 800-811-8480

Igor Puzanov
Principal Investigator

Virginia
Richmond

Virginia Commonwealth University/Massey Cancer Center

Andrew Poklepovic
Ph: 804-628-1939

Andrew Poklepovic
Principal Investigator

Washington
Seattle

Virginia Mason CCOP

Craig R. Nichols
Ph: 503-215-6412
Email: vmmc.cancer_clinical_research@VirginiaMason.org

Craig R. Nichols
Principal Investigator

West Virginia
Charleston

West Virginia University Charleston

Steven James Jubelirer
Ph: 304-344-3457

Steven James Jubelirer
Principal Investigator

Morgantown

West Virginia University Healthcare

Miklos Laszlo Auber
Ph: 304-293-2745
Email: sfilburn@hsc.wvu.edu

Miklos Laszlo Auber
Principal Investigator

Wisconsin
Green Bay

Saint Vincent Hospital

Brian Leslie Burnette
Ph: 800-432-6049

Brian Leslie Burnette
Principal Investigator

Madison

University of Wisconsin Hospital and Clinics

Mark Richard Albertini
Ph: 877-405-6866

Mark Richard Albertini
Principal Investigator

Marshfield

Marshfield Clinic

Seth Olusegun Fagbemi
Ph: 715-389-4457

Seth Olusegun Fagbemi
Principal Investigator

Milwaukee

Aurora Cancer Care-Milwaukee South

Rubina Qamar
Ph: 888-709-2080

Rubina Qamar
Principal Investigator

Canada

Manitoba
Winnipeg

CancerCare Manitoba

Ralph P. W. Wong
Ph: 866-561-1026
Email: CIO_Web@cancercare.mb.ca

Ralph P. W. Wong
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01274338

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.