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

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIBiomarker/Laboratory analysis, TreatmentActive18 and overNCINCI-2011-02649
ECOG-E1609, CDR0000692568, E1609, U10CA180820, U10CA021115, 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:

  • 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
  • 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 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 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
  • 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
  • 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
  • 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 have Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Patients must not have an active infection requiring current treatment with parenteral antibiotics
  • 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
  • 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
  • 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 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 had any infectious disease vaccination (e.g., standard influenza, H1N1 influenza, pneumococcal, meningococcal, or tetanus toxoid) within 4 weeks prior to randomization
  • 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 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
  • 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
  • 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
  • White blood cell (WBC) >= 3,000/uL
  • Absolute neutrophil count (ANC) >= 1,500/uL
  • Platelets >= 100 x 10^3/uL
  • Hemoglobin >= 10 g/dL
  • Serum creatinine =< 1.5 mg/dL
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x ULN
  • Serum bilirubin =< 1.5 x ULN, (except patients with Gilbert's syndrome, who must have a total bilirubin less than 3.0 mg/dL)
  • 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

Trial Contact Information

Trial Lead Organizations/Sponsors

National Cancer Institute

    Ahmad Tarhini, Principal Investigator

    Trial Sites

    U.S.A.

    Arizona
    Tucson

    Arizona Cancer Center at University of Arizona Health Sciences Center

    Joanne M Jeter
    Ph: 520-626-9008

    California
    Los Angeles

    Mattel Children's Hospital at UCLA

    Bartosz Chmielowski
    Ph: 888-798-0719

    Oakland

    Kaiser Permanente-Oakland

    Louis Fehrenbacher
    Ph: 626-564-3455

    Sacramento

    Sutter Cancer Center

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

    District of Columbia
    Washington

    Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

    Michael Benjamin Atkins
    Ph: 202-444-0381

    Florida
    Gainesville

    UF Health Cancer Center

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

    Miami

    University of Miami Sylvester Comprehensive Cancer Center - Miami

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

    Stuart

    Robert and Carol Weissman Cancer Center at Martin Memorial

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

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

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

    Georgia
    Atlanta

    CCOP - Atlanta Regional

    Thomas E. Seay
    Ph: 404-303-3355

    Augusta

    Medical College of Georgia Cancer Center

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

    Columbus

    John B. Amos Cancer Center

    Thomas E. Seay
    Ph: 404-303-3355

    Hawaii
    Honolulu

    Kapiolani Medical Center for Women and Children

    Jeffrey L. Berenberg
    Ph: 808-586-2979

    Idaho
    Boise

    Mountain States Tumor Institute at St. Luke's Regional Medical Center

    Paul G. Montgomery
    Ph: 800-845-4624

    Illinois
    Galesburg

    Medical and Surgical Specialists, LLC

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

    Maywood

    Cardinal Bernardin Cancer Center at Loyola University Medical Center

    Joseph I. Clark
    Ph: 708-226-4357

    Springfield

    Simmons Cooper Cancer Institute

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

    Urbana

    Carle Cancer Center at Carle Foundation Hospital

    Adam I Riker
    Ph: 800-323-8622

    Iowa
    Iowa City

    Holden Comprehensive Cancer Center at University of Iowa

    Mohammed M Milhem
    Ph: 800-237-1225

    Kansas
    Shawnee Mission

    Kansas City Cancer Center - Shawnee Mission

    Peter J. VanVeldhuizen
    Ph: 800-525-1483

    Louisiana
    New Orleans

    Ochsner Cancer Institute at Ochsner Clinic Foundation

    Jyotsna Fuloria
    Ph: 888-562-4763

    Maryland
    Baltimore

    Alvin and Lois Lapidus Cancer Institute at Sinai Hospital

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

    Massachusetts
    Boston

    Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute

    F. Stephen Hodi
    Ph: 866-790-4500

    Massachusetts General Hospital

    F. Stephen Hodi
    Ph: 866-790-4500

    Springfield

    Baystate Medical Center

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

    Worcester

    UMASS Memorial Cancer Center - University Campus

    Ahmad D Siddiqui
    Ph: 508-856-3216
    Email: cancer.research@umassmed.edu

    Michigan
    Ann Arbor

    University of Michigan Comprehensive Cancer Center

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

    Detroit

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

    Philip J. Stella
    Ph: 734-712-4673

    Wayne State University

    Lawrence E. Flaherty
    Ph: 313-576-9363

    Flint

    Hurley Medical Center

    Philip J. Stella
    Ph: 734-712-4673

    Grand Rapids

    Butterworth Hospital at Spectrum Health

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

    Kalamazoo

    West Michigan Cancer Center

    Sunil Nagpal
    Ph: 269-373-7458

    Missouri
    Saint Louis

    David C. Pratt Cancer Center at St. John's Mercy

    Jay W Carlson
    Ph: 800-821-7532

    Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

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

    Nebraska
    Omaha

    CCOP - Missouri Valley Cancer Consortium

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

    Nevada
    Las Vegas

    Cancer Institute of Nevada at Summerlin Hospital Medical Center

    John Allan Ellerton
    Ph: 702-384-0013

    CCOP - Nevada Cancer Research Foundation

    John Allan Ellerton
    Ph: 702-384-0013

    New Hampshire
    Lebanon

    Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Marc Stuart Ernstoff
    Ph: 866-223-8100

    New Jersey
    Hackensack

    CCOP - Northern New Jersey

    Donna T McNamara
    Ph: 201-996-2879

    Hackensack University Medical Center Cancer Center

    Donna T McNamara
    Ph: 201-996-2879

    Morristown

    Carol G. Simon Cancer Center at Morristown Memorial Hospital

    Eric D Whitman
    Ph: 973-971-5900

    New Mexico
    Albuquerque

    University of New Mexico Cancer Center

    Montaser Shaheen
    Ph: 505-272-6972

    New York
    Glens Falls

    Charles R. Wood Cancer Center at Glens Falls Hospital

    John P Stoutenburg
    Ph: 518-926-6700

    Rochester

    James P. Wilmot Cancer Center at University of Rochester Medical Center

    Jonathan W Friedberg
    Ph: 585-275-5830

    North Carolina
    Asheville

    Mission Hospitals - Memorial Campus

    Christopher H Chay
    Ph: 828-213-4150

    Chapel Hill

    Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

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

    Charlotte

    Blumenthal Cancer Center at Carolinas Medical Center

    Asim Amin
    Ph: 704-355-2884

    Durham

    Duke Cancer Institute

    Jeffrey Crawford
    Ph: 888-275-3853

    Greenville

    Leo W. Jenkins Cancer Center at ECU Medical School

    Prashanti Atluri
    Ph: 252-744-2161

    Rutherfordton

    Rutherford Hospital

    Charles E Bowers
    Ph: 800-486-5941

    North Dakota
    Bismarck

    Bismarck Cancer Center

    Edward J. Wos
    Ph: 701-323-5760
    Email: tfischer@mohs.org

    Ohio
    Cleveland

    Cleveland Clinic Taussig Cancer Center

    Anjali S Advani
    Ph: 866-223-8100

    Toledo

    Toledo Hospital

    Rex B Mowat
    Ph: 800-444-3561

    Oklahoma
    Oklahoma City

    Mercy Health Center

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

    Stephenson Cancer Center at the University of Oklahoma

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

    Oregon
    Portland

    Knight Cancer Institute at Oregon Health and Science University

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

    Providence St. Vincent Medical Center

    Keith S. Lanier
    Ph: 503-215-6412

    Pennsylvania
    Bethlehem

    Lehigh Valley Hospital - Muhlenberg

    Eliot Lawrence Friedman
    Ph: 610-402-2273

    Danville

    Geisinger Cancer Institute at Geisinger Health

    Christian Adonizio
    Ph: 570-271-5251

    South Carolina
    Anderson

    AnMed Cancer Center

    Charles E Bowers
    Ph: 800-486-5941

    Greenville

    Greenville Memorial Hospital

    Jeffrey Kent Giguere
    Ph: 864-241-6251

    South Dakota
    Sioux Falls

    Sanford Cancer Center at Sanford USD Medical Center

    Preston D. Steen
    Ph: 701-234-6161

    Tennessee
    Nashville

    Vanderbilt-Ingram Cancer Center

    Igor Puzanov
    Ph: 800-811-8480

    Virginia
    Richmond

    Virginia Commonwealth University Massey Cancer Center

    Andrew Poklepovic
    Ph: 804-628-1939

    Washington
    Seattle

    CCOP - Virginia Mason Research Center

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

    West Virginia
    Charleston

    West Virginia University Medical School - Charleston

    Steven J. Jubelirer
    Ph: 304-344-3457

    Morgantown

    Mary Babb Randolph Cancer Center at West Virginia University Hospitals

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

    Wisconsin
    Green Bay

    St. Vincent Hospital Regional Cancer Center

    Brian L Burnette
    Ph: 800-432-6049

    Madison

    University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

    Mark R. Albertini
    Ph: 877-405-6866

    Marshfield

    Marshfield Clinic - Marshfield Center

    Seth Olusegun Fagbemi
    Ph: 715-389-4457

    Milwaukee

    Oncology Alliance, SC - Milwaukee - South

    Rubina Qamar
    Ph: 888-709-2080

    Canada

    Manitoba
    Winnipeg

    CancerCare Manitoba

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

    Link to the current ClinicalTrials.gov record.
    NLM Identifier NCT01274338
    ClinicalTrials.gov processed this data on May 21, 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.