Combination Chemotherapy in Treating Patients With Non-Metastatic Extracranial Ewing Sarcoma

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIBiomarker/Laboratory analysis, TreatmentActive50 and underNCI, OtherAEWS1031
NCI-2011-02611, COG-AEWS1031, CDR0000687639, U10CA098543, NCT01231906

Trial Description

Summary

This randomized phase III trial studies combination chemotherapy to see how well it works compared to combination chemotherapy with topotecan hydrochloride in treating patients with non-metastatic extracranial Ewing sarcoma. Drugs used in chemotherapy, such as vincristine sulfate, doxorubicin hydrochloride, cyclophosphamide, ifosfamide, etoposide, and topotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether combination chemotherapy is more effective with topotecan hydrochloride in treating Ewing sarcoma.

Further Study Information

PRIMARY OBJECTIVES:

l. Test the effect of the combination of vincristine (vincristine sulfate), cyclophosphamide, and topotecan (topotecan hydrochloride) (VTC) added to the standard 5-drug chemotherapy interval-compressed backbone on event-free and overall survival of children and young adults with Ewing sarcoma.

SECONDARY OBJECTIVES:

I. To evaluate initial volumetric tumor size as a prognostic factor for event free survival (EFS) in patients with localized Ewing tumors.

II. To evaluate histologic response as a prognostic factor for EFS in patients with localized Ewing tumors.

III. To continue evaluation of biologic markers both as related to prognosis and as eventual therapeutic targets via encouraging concurrent enrollment on a Ewing sarcoma specimen-collection study.

IV. To evaluate imaging response by fludeoxyglucose F 18 (FDG)-positron emission tomography (PET) as a prognostic factor for EFS.

V. To evaluate the effects of the type of local therapy on EFS and overall survival.

VI. To evaluate the effect of local surgical margins in conjunction with histologic response on EFS in patients with localized Ewing tumors.

VII. To evaluate the effect of local therapy modality (surgery, radiotherapy, or a combination) as well as the type of surgical reconstruction on musculoskeletal complications.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I:

INDUCTION THERAPY: Patients receive vincristine sulfate intravenously (IV) on day 1 in weeks 1, 2, 5, 6, 9, and 10; doxorubicin hydrochloride IV on days 1 and 2 and cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 5, and 9; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 7, and 11.

CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 7, 8, 9, 10, 13, 14, 17, 18, 21, and 22; doxorubicin hydrochloride IV on days 1 and 2 in weeks 1 and 9; cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 7, 9, 13, 17, and 21; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 5, 11, 15, and 19.

ARM II:

INDUCTION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 5, 6, 9, 10, 11 and 12; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1 and 9; cyclophosphamide IV over 15-60 minutes on days 1-5 in weeks 1 and 9, and on day 1 of weeks 5 and 11; ifosfamide and etoposide as in arm I; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 5 and 11.

CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 7-10, 13-16, 19, and 20; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1, 7, and 15; cyclophosphamide IV over 15-60 minutes on days 1-5 in weeks 1, 7, and 15, and on day 1 in weeks 9, 13, and 19; ifosfamide IV over 1 hour and etoposide IV over 1- 2 hours on days 1-5 in weeks 3, 5, 11, 17, and 21; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 9,13, and 19.

Patients with responsive or stable disease undergo may undergo surgery alone in week 13 if lesion can be complete resected with negative margins and with reasonable functional result. Patients with unresectable lesions or inadequate margins after surgery receive radiotherapy during weeks 1-7. Patients with bulky lesions in surgically difficult sites such as the spine, skull, and periacetabular pelvis, patients with a poor response to induction chemotherapy, or those patients in whom surgery would result in unacceptable functional results may undergo radiotherapy alone in weeks 1-7 of consolidation therapy, and surgery should be performed after completion of consolidation chemotherapy. Patients with microscopic residual disease after planned pre-operative radiotherapy receive additional radiotherapy.

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

Eligibility Criteria

Inclusion Criteria:

  • Patients with newly diagnosed, biopsy confirmed, extracranial, non-metastatic Ewing sarcoma or primitive neuroectodermal tumor (PNET) of bone or soft tissue are eligible for this study; note:
  • For the purpose of this study, chest wall tumors with ipsilateral pleural effusions, ipsilateral positive pleural fluid cytology or ipsilateral pleural based secondary tumor nodules will be considered localized disease
  • Patients with regional node involvement, based on clinical suspicion confirmed by pathologic documentation are considered to be non-metastatic
  • Patients with discontinuous osseous lesions within the same bone are considered to be non-metastatic
  • Tumors arising in the bony skull (extra-dural) are considered to be extracranial
  • Patient eligibility will be based on a diagnosis of Ewing sarcoma or PNET by institutional pathologist
  • No prior chemotherapy or radiation therapy is allowed; patients should only have had a biopsy of the primary tumor without an attempt at complete or partial resection; patients will still be eligible if unplanned excision was attempted or accomplished as long as adequate imaging was obtained prior to surgery
  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70mL/min/1.73 m^2 or serum creatinine based on age/gender as follows:
  • 1 month to < 6 months: 0.4 mg/dL
  • 6 months to < 1 year: 0.5 mg/dL
  • 1 to < 2 years: 0.6 mg/dL
  • 2 to < 6 years: 0.8 mg/dL
  • 6 to < 10 years: 1 mg/dL
  • 10 to < 13 years: 1.2 mg/dL
  • 13 to < 16 years: 1.5 mg/dL (male), 1.4 mg/dL (female)
  • >= 16 years: 1.7 mg/dL (male), 1.4 mg/dL (female)
  • Total bilirubin < 1.5 x upper limit of normal (ULN) for age
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x upper limit of normal (ULN) for age
  • Shortening fraction of >= 27% by echocardiogram, or ejection fraction of >= 50% by radionuclide angiogram

Exclusion Criteria:

  • Patients must have no evidence of metastatic disease; metastatic disease:
  • Are lesions which are discontinuous from the primary tumor, are not regional lymph nodes and do not share a body cavity with the primary tumor; if there is any doubt whether lesions are metastatic, a biopsy of those lesions should be taken
  • Skeletal lesions in adjacent bones (trans-articular)
  • Contralateral pleural effusion and contralateral pleural nodules
  • Distant lymph node involvement
  • Patients with pulmonary nodules are considered to have metastatic disease if the patient has:
  • Solitary nodule > 0.5 cm or multiple nodules of > 0.3 cm unless biopsied and negative for Ewing's
  • Biopsies of solitary nodule =< 0.5 cm or multiple nodules =< 0.3 cm are not required but if performed and positive indicate metastatic disease
  • Patients whose tumors arise in the dural and intra-dural soft tissues of the cranium and spine are not eligible
  • Patients with pathologic diagnoses other than Ewing sarcoma will be excluded
  • Patients diagnosed with Ewing Sarcoma as a second malignant neoplasm are not eligible if they have received chemotherapy or radiation for the treatment of their primary malignancy
  • Pregnant women will not be entered on this study; pregnancy tests must be obtained in female patients who are post-menarchal; lactating females may not participate unless they have agreed not to breastfeed their infants; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method for the duration of the study treatment
  • All patients and/or their parents or legal guardians must sign a written informed consent
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Trial Contact Information

Trial Lead Organizations/Sponsors

Children's Oncology Group

  • National Cancer Institute
Patrick Leavey, MD, Principal Investigator

Trial Sites

U.S.A.

Alabama
Birmingham

Children's Hospital of Alabama at University of Alabama at Birmingham

Alyssa T Reddy
Ph: 888-823-5923
Email: ctsucontact@westat.com

Mobile

University of South Alabama Mitchell Cancer Institute

Felicia L Wilson
Ph: 251-665-8000

Alaska
Anchorage

Providence Cancer Center

Brenda J Wittman
Ph: 907-261-3109

Arizona
Phoenix

Phoenix Children's Hospital

Jessica Boklan
Ph: 602-546-0920

Tucson

Arizona Cancer Center at University of Arizona Health Sciences Center

Lisa M Kopp
Ph: 520-626-9008

Arkansas
Little Rock

Arkansas Children's Hospital at the University of Arkansas for Medical Sciences

David L Becton
Ph: 501-364-7373

California
Downey

Southern California Permanente Medical Group

Robert M Cooper
Ph: 626-564-3455

Duarte

City of Hope Comprehensive Cancer Center

Anna B Pawlowska
Ph: 800-826-4673
Email: becomingapatient@coh.org

Loma Linda

Loma Linda University Cancer Institute at Loma Linda University Medical Center

Antranik A Bedros
Ph: 909-558-3375

Long Beach

Jonathan Jaques Children's Cancer Center at Miller Children's Hospital

Theodore Zwerdling
Ph: 562-933-5600

Los Angeles

Children's Hospital Los Angeles

Leo Mascarenhas
Ph: 323-361-4110

Jonsson Comprehensive Cancer Center at UCLA

Pamela H Kempert
Ph: 310-825-6708

Mattel Children's Hospital at UCLA

Noah C Federman
Ph: 310-825-6708

Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

Fataneh (Fae) Majlessipour
Ph: 310-423-8965

Madera

Children's Hospital Central California

Vonda L Crouse
Ph: 866-353-5437

Oakland

Children's Hospital and Research Center Oakland

Carla B Golden
Ph: 510-450-7600

Kaiser Permanente-Oakland

Steven K Bergstrom
Ph: 626-564-3455

Orange

Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

Leonard S. Sender
Ph: 877-827-8839
Email: ucstudy@uci.edu

Children's Hospital of Orange County

Violet Shen
Ph: 714-997-3000

Palo Alto

Lucile Packard Children's Hospital at Stanford University Medical Center

Neyssa M Marina
Ph: 650-498-7061
Email: clinicaltrials@med.stanford.edu

Sacramento

Sutter Cancer Center

Yung S Yim
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

University of California Davis Cancer Center

Jay Michael S Balagtas
Ph: 916-734-3089

San Diego

Rady Children's Hospital - San Diego

William D Roberts
Ph: 858-966-5934

San Francisco

UCSF Helen Diller Family Comprehensive Cancer Center

Steven G DuBois
Ph: 877-827-3222

Colorado
Aurora

Children's Hospital Colorado Center for Cancer and Blood Disorders

Timothy P Garrington
Ph: 720-777-6672

Denver

Presbyterian - St. Luke's Medical Center

Jennifer J Clark
Ph: 866-775-6246

Connecticut
Hartford

Connecticut Children's Medical Center

Michael S Isakoff
Ph: 860-545-9981

New Haven

Yale Cancer Center

Nina S Kadan-Lottick
Ph: 203-785-5702

Delaware
Wilmington

Alfred I. duPont Hospital for Children

Scott M Bradfield
Ph: 904-697-3529

District of Columbia
Washington

Children's National Medical Center

Jeffrey S Dome
Ph: 202-884-2549

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Aziza T Shad
Ph: 202-444-0381

Florida
Fort Lauderdale

Broward General Medical Center Cancer Center

Hector M Rodriguez-Cortes
Ph: 954-355-5346

Fort Myers

Children's Hospital of Southwest Florida

Emad K Salman
Ph: 239-343-5333

Hollywood

Joe DiMaggio Children's Hospital

Iftikhar Hanif
Ph: 954-265-2234

Jacksonville

Nemours Children's Clinic

Scott M Bradfield
Ph: 904-697-3529

Miami

Baptist-South Miami Regional Cancer Program

Doured Daghistani
Ph: 800-599-2456
Email: cancerinfo@baptisthealth.net

University of Miami Sylvester Comprehensive Cancer Center - Miami

Julio C Barredo
Ph: 866-574-5124
Email: Sylvester@emergingmed.com

Orlando

Arnold Palmer Hospital for Children

Vincent F Giusti
Ph: 321-841-7246
Email: CancerClinicalTrials@orlandohealth.com

Florida Hospital Cancer Institute at Florida Hospital Orlando

Fouad M Hajjar
Ph: 407-303-5623

Nemours Children's Hospital

Scott M Bradfield
Ph: 904-697-3529

Pensacola

Nemours Children's Clinic - Pensacola

Scott M Bradfield
Ph: 904-697-3529

Saint Petersburg

All Children's Hospital

Gregory A Hale
Ph: 727-767-2423
Email: HamblinF@allkids.org

Tampa

St. Joseph's Children's Hospital of Tampa

Erin M Cockrell
Ph: 800-882-4123

West Palm Beach

Kaplan Cancer Center at St. Mary's Medical Center

Narayana Gowda
Ph: 888-823-5923
Email: ctsucontact@westat.com

Georgia
Atlanta

AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus

Howard M Katzenstein
Ph: 800-811-8480

Augusta

Medical College of Georgia Cancer Center

Colleen H McDonough
Ph: 706-721-1663
Email: cancer@georgiahealth.edu

Savannah

Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

J. M Johnston
Ph: 912-350-8568

Hawaii
Honolulu

Kapiolani Medical Center for Women and Children

Robert W Wilkinson
Ph: 808-983-6090

Straub Clinic and Hospital, Incorporated

Robert W Wilkinson
Ph: 808-983-6090

Tripler Army Medical Center

Jeremy V Edwards
Ph: 808-433-6336

Idaho
Boise

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

Eugenia Chang
Ph: 800-845-4624

Illinois
Chicago

Ann and Robert H. Lurie Children's Hospital of Chicago

David O Walterhouse
Ph: 773-880-4562

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Mark Agulnik
Ph: 312-695-1301
Email: cancer@northwestern.edu

University of Chicago Cancer Research Center

Susan L Cohn
Ph: 773-834-7424

University of Illinois Cancer Center

Mary L Schmidt
Ph: 312-355-3046

Maywood

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Eugene Suh
Ph: 708-226-4357

Oak Lawn

Keyser Family Cancer Center at Advocate Hope Children's Hospital

Rebecca E McFall
Ph: 847-723-7570

Park Ridge

Advocate Children's Hospital-Park Ridge

Jong-Hyo Kwon
Ph: 847-384-3621

Peoria

Saint Jude Midwest Affiliate

Karen S Fernandez
Ph: 309-655-3258

Springfield

Cancer Institute at St. John's Hospital

Gregory P Brandt
Ph: 217-545-7929

Regional Cancer Center at Memorial Medical Center

Gregory P Brandt
Ph: 217-545-7929

Simmons Cooper Cancer Institute

Gregory P Brandt
Ph: 217-545-7929

Indiana
Indianapolis

Riley's Children Cancer Center at Riley Hospital for Children

Robert J Fallon
Ph: 888-823-5923
Email: ctsucontact@westat.com

St. Vincent Indianapolis Hospital

Bassem I Razzouk
Ph: 317-338-2194

Iowa
Des Moines

Blank Children's Hospital

Wendy L Woods-Swafford
Ph: 515-241-6729

Iowa City

Holden Comprehensive Cancer Center at University of Iowa

Ayman A El-Sheikh
Ph: 800-237-1225

Sioux City

Siouxland Hematology-Oncology Associates, LLP

Donald Bruce Wender
Ph: 712-252-0088

Kentucky
Lexington

University of Kentucky Chandler Medical Center

Lars M Wagner
Ph: 859-257-3379

Louisville

Kosair Children's Hospital

Kenneth G Lucas
Ph: 866-530-5516

Louisiana
New Orleans

Children's Hospital of New Orleans

Lolie C Yu
Ph: 504-894-5377

Ochsner Cancer Institute at Ochsner Clinic Foundation

Craig Lotterman
Ph: 888-562-4763

Maine
Bangor

CancerCare of Maine at Eastern Maine Medical Center

Sarah J Fryberger
Ph: 207-973-4274

Scarborough

Maine Children's Cancer Program at Barbara Bush Children's Hospital

Aaron R Weiss
Ph: 207-396-8090
Email: wrighd@mmc.org

Maryland
Baltimore

Alvin and Lois Lapidus Cancer Institute at Sinai Hospital

Joseph M Wiley
Ph: 410-601-6120
Email: pridgely@lifebridgehealth.org

Greenebaum Cancer Center at University of Maryland Medical Center

Teresa A York
Ph: 800-888-8823

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

David M Loeb
Ph: 410-955-8804
Email: jhcccro@jhmi.edu

Bethesda

National Naval Medical Center

Anne B Warwick
Ph: 301-319-2100

Massachusetts
Boston

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

Carlos Rodriguez-Galindo
Ph: 866-790-4500

Massachusetts General Hospital

Howard J Weinstein
Ph: 877-726-5130

Springfield

Baystate Medical Center

Joanna G Luty
Ph: 413-794-3565
Email: tamara.wrenn@baystatehealth.org

Worcester

UMASS Memorial Cancer Center - University Campus

Christopher P Keuker
Ph: 508-856-3216
Email: cancer.research@umassmed.edu

Michigan
Ann Arbor

C.S. Mott Children's Hospital at University of Michigan Medical Center

Brenda J Kitchen
Ph: 248-551-7695

Detroit

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

Hadi Sawaf
Ph: 313-343-3166

Wayne State University

Roland L Chu
Ph: 313-576-9363

East Lansing

Breslin Cancer Center at Ingham Regional Medical Center

Renuka Gera
Ph: 517-975-9547

Flint

Hurley Medical Center

Susumu Inoue
Ph: 888-606-6556

Grand Rapids

Helen DeVos Children's Hospital at Spectrum Health

David S Dickens
Ph: 616-267-1925

Kalamazoo

Bronson Methodist Hospital

Jeffrey S Lobel
Ph: 800-227-2345

Royal Oak

William Beaumont Hospital - Royal Oak Campus

Laura K Gowans
Ph: 248-551-7695

Minnesota
Minneapolis

Children's Hospitals and Clinics of Minnesota - Minneapolis

Bruce C Bostrom
Ph: 612-813-5193

Masonic Cancer Center at University of Minnesota

Brenda J Weigel
Ph: 612-624-2620

Rochester

Mayo Clinic Cancer Center

Nadia N Laack
Ph: 507-538-7623

Mississippi
Jackson

University of Mississippi Cancer Clinic

Gail C Megason
Ph: 601-815-6700

Missouri
Columbia

Columbia Regional Hospital

Thomas W Loew
Ph: 573-882-7440

Kansas City

Children's Mercy Hospital

Maxine L Hetherington
Ph: 816-234-3265

Saint Louis

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

Bethany G. Sleckman
Ph: 913-948-5588

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

Frederick S Huang
Ph: 800-600-3606
Email: info@siteman.wustl.edu

Nebraska
Omaha

Children's Hospital

Minnie Abromowitch
Ph: 402-955-3949

Fred and Pamela Buffett Cancer Center

Minnie Abromowitch
Ph: 402-955-3949

Nevada
Las Vegas

Cancer Institute of Nevada at Summerlin Hospital Medical Center

Jonathan Bernstein
Ph: 702-384-0013

CCOP - Nevada Cancer Research Foundation

Jonathan Bernstein
Ph: 702-384-0013

Children's Specialty Center of Nevada

Jonathan Bernstein
Ph: 702-384-0013

Sunrise Hospital and Medical Center

Nik Farahana N Rashid
Ph: 702-384-0013

University Medical Center of Southern Nevada

Jonathan Bernstein
Ph: 702-384-0013

New Hampshire
Lebanon

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Sara Chaffee
Ph: 800-639-6918
Email: cancer.research.nurse@dartmouth.edu

New Jersey
Hackensack

Hackensack University Medical Center Cancer Center

Michael B Harris
Ph: 201-996-2879

Morristown

Carol G. Simon Cancer Center at Morristown Memorial Hospital

Steven L Halpern
Ph: 973-971-5900

New Brunswick

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

Richard A Drachtman
Ph: 732-235-8675

Saint Peter's University Hospital

Stanley Calderwood
Ph: 732-745-8600ext6163
Email: kcovert@saintpetersuh.com

Newark

Newark Beth Israel Medical Center

Peri Kamalakar
Ph: 973-926-7230

Paterson

St. Joseph's Hospital and Medical Center

Mary A Bonilla
Ph: 973-754-2909

Summit

Overlook Hospital

Steven L Halpern
Ph: 973-971-5900

New Mexico
Albuquerque

University of New Mexico Cancer Center

Koh B Boayue
Ph: 505-272-6972

New York
Albany

Albany Medical Center Hospital

Vikramjit S Kanwar
Ph: 518-262-3368

Bronx

Montefiore Medical Center

Peter D Cole
Ph: 718-904-2730
Email: aecc@aecom.yu.edu

Buffalo

Roswell Park Cancer Institute

Martin L Brecher
Ph: 877-275-7724

New Hyde Park

Schneider Children's Hospital

Carolyn F Levy
Ph: 718-470-3470

New York

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

Alice Lee
Ph: 212-305-8615

Mount Sinai Medical Center

Birte Wistinghausen
Ph: 212-824-7320
Email: jenny.figueroa@mssm.edu

New York University Medical Center

Linda Granowetter
Ph: 212-263-4434
Email: prmc.coordinator@nyumc.org

Rochester

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

Lisa R Hackney
Ph: 585-275-5830

Stony Brook

Stony Brook University Cancer Center

Robert I Parker
Ph: 800-862-2215

Syracuse

SUNY Upstate Medical University Hospital

Karol H Kerr
Ph: 315-464-5476

Valhalla

New York Medical College

Jessica C Hochberg
Ph: 914-594-3794

North Carolina
Asheville

Mission Hospitals - Memorial Campus

Douglas J Scothorn
Ph: 828-213-4150

Chapel Hill

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

Stuart H Gold
Ph: 877-668-0683
Email: cancerclinicaltrials@med.unc.edu

Charlotte

Blumenthal Cancer Center at Carolinas Medical Center

Joel A Kaplan
Ph: 704-355-2884

Presbyterian Cancer Center at Presbyterian Hospital

Paulette C Bryant
Ph: 704-384-5369

Durham

Duke Cancer Institute

Susan G Kreissman
Ph: 888-275-3853

Winston-Salem

Wake Forest University Comprehensive Cancer Center

Thomas W McLean
Ph: 336-713-6771

North Dakota
Fargo

Roger Maris Cancer Center at MeritCare Hospital

Samuel O Anim
Ph: 701-234-6161

Ohio
Akron

Akron Children's Hospital

Steven J Kuerbitz
Ph: 330-543-3193

Cincinnati

Cincinnati Children's Hospital Medical Center

John P Perentesis
Ph: 513-636-2799

Cleveland

Cleveland Clinic Taussig Cancer Center

Margaret C Thompson
Ph: 866-223-8100

Seidman Cancer Center at University Hospitals/Case Medical Center

Yousif (Joe) H Matloub
Ph: 216-844-5437

Columbus

Nationwide Children's Hospital

Mark A Ranalli
Ph: 614-722-2708

Dayton

Dayton Children's - Dayton

Emmett H Broxson
Ph: 800-228-4055

Toledo

Mercy Children's Hospital

Rama Jasty
Ph: 419-251-8210

Toledo Hospital

Jamie L Dargart
Ph: 419-824-1842

Oklahoma
Oklahoma City

Stephenson Cancer Center at the University of Oklahoma

Rene Y McNall-Knapp
Ph: 405-271-4272
Email: julie-traylor@ouhsc.edu

Tulsa

Natalie Warren Bryant Cancer Center at St. Francis Hospital

Gregory B Kirkpatrick
Ph: 918-494-2200

Oregon
Portland

Knight Cancer Institute at Oregon Health and Science University

Suman Malempati
Ph: 503-494-1080
Email: trials@ohsu.edu

Legacy Emanuel Children's Hospital

Janice F Olson
Ph: 503-413-2560

Legacy Emanuel Hospital and Health Center and Children's Hospital

Janice F Olson
Ph: 503-413-2560

Providence St. Vincent Medical Center

Matthew C Solhjem
Ph: 503-215-6412
Email: Julie.Cramer@providence.org

Pennsylvania
Bethlehem

Lehigh Valley Hospital - Muhlenberg

Philip M Monteleone
Ph: 484-884-2201

Danville

Geisinger Cancer Institute at Geisinger Health

Jagadeesh Ramdas
Ph: 570-271-5251

Hershey

Penn State Children's Hospital

Lisa M McGregor
Ph: 717-531-6012

Philadelphia

Children's Hospital of Philadelphia

Richard B Womer
Ph: 215-590-2810

Fox Chase Cancer Center - Philadelphia

Margaret von Mehren
Ph: 215-728-4790

St. Christopher's Hospital for Children

Gregory E Halligan
Ph: 215-427-8991

Pittsburgh

Children's Hospital of Pittsburgh of UPMC

Michael R Wollman
Ph: 412-692-5573

PR
San Juan

San Jorge Children's Hospital

Luis A Clavell
Ph: 787-765-2363

Rhode Island
Providence

Rhode Island Hospital Comprehensive Cancer Center

Jennifer J Greene Welch
Ph: 401-444-1488

South Carolina
Charleston

Hollings Cancer Center at Medical University of South Carolina

Jacqueline M Kraveka
Ph: 843-792-9321

Columbia

Palmetto Health South Carolina Cancer Center

Ronnie W. Neuberg
Ph: 803-434-3680

Greenville

BI-LO Charities Children's Cancer Center

Nichole L Bryant
Ph: 864-241-6251

Cancer Centers of the Carolinas - Faris Road

Cary E Stroud
Ph: 864-241-6251

South Dakota
Sioux Falls

Sanford Cancer Center at Sanford USD Medical Center

Kayelyn J Wagner
Ph: 605-328-1367

Tennessee
Chattanooga

T.C. Thompson Children's Hospital

Manoo G Bhakta
Ph: 423-778-7289

Knoxville

East Tennessee Children's Hospital

Ray C Pais
Ph: 865-541-8266

Memphis

St. Jude Children's Research Hospital

Fariba Navid
Ph: 866-278-5833
Email: info@stjude.org

Nashville

Vanderbilt-Ingram Cancer Center

Scott C Borinstein
Ph: 800-811-8480

Texas
Austin

Dell Children's Medical Center of Central Texas

Amy C Fowler
Ph: 214-648-7097

Corpus Christi

Driscoll Children's Hospital

M. C Johnson
Ph: 361-694-5311

Dallas

Medical City Dallas Hospital

Carl Lenarsky
Ph: 972-566-5588

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Patrick J Leavey
Ph: 214-648-7097

El Paso

El Paso Children's Hospital

Lisa L Hartman
Ph: 888-823-5923
Email: ctsucontact@westat.com

Fort Worth

Cook Children's Medical Center - Fort Worth

Lauren J Akers
Ph: 682-885-2103

Houston

Dan L. Duncan Cancer Center at Baylor College of Medicine

Lisa L Wang
Ph: 713-798-1354
Email: burton@bcm.edu

M. D. Anderson Cancer Center at University of Texas

Cynthia E Herzog
Email: cherzog@mdanderson.org

Univeristy of Texas M.D. Anderson Cancer Center

Cynthia E Herzog
Ph: 713-792-3245

Lubbock

Covenant Children's Hospital

Latha Prasannan
Ph: 806-725-8000
Email: jaccresearch@covhs.org

San Antonio

Children's Hospital of San Antonio

Timothy C Griffin
Ph: 713-798-1354
Email: burton@bcm.edu

University of Texas Health Science Center at San Antonio

Anne-Marie R Langevin
Ph: 210-450-3800
Email: CTO@uthscsa.edu

Temple

Scott and White Cancer Institute

Guy H Grayson
Ph: 254-724-5407

Utah
Salt Lake City

Primary Children's Medical Center

Phillip E Barnette
Ph: 801-585-5270

Vermont
Burlington

University of Vermont Cancer Center

Alan C Homans
Ph: 802-656-4101

Virginia
Charlottesville

University of Virginia Cancer Center

Kimberly P Dunsmore
Ph: 434-243-6143

Falls Church

Inova Fairfax Hospital

Marshall A Schorin
Ph: 703-208-6650

Norfolk

Children's Hospital of The King's Daughters

Eric J Lowe
Ph: 757-668-7243

Portsmouth

Naval Medical Center - Portsmouth

Bethany M Mikles
Ph: 757-953-5939

Richmond

Virginia Commonwealth University Massey Cancer Center

Gita V Massey
Ph: 804-628-1939

Washington
Seattle

Children's Hospital and Regional Medical Center - Seattle

Douglas S Hawkins
Ph: 866-987-2000

Spokane

Providence Cancer Center at Sacred Heart Medical Center

Judy L Felgenhauer
Ph: 800-228-6618
Email: HopeBeginsHere@providence.org

Tacoma

Madigan Army Medical Center - Tacoma

Melissa A Forouhar
Ph: 253-968-0129
Email: mamcdci@amedd.army.mil

Mary Bridge Children's Hospital and Health Center - Tacoma

Robert G Irwin
Ph: 253-403-3229

West Virginia
Charleston

West Virginia University Medical School - Charleston

Howard M Grodman
Ph: 304-388-9944

Wisconsin
Green Bay

St. Vincent Hospital Regional Cancer Center

John R Hill
Ph: 920-433-8889

Madison

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Kenneth B DeSantes
Ph: 608-262-5223

Marshfield

Marshfield Clinic - Marshfield Center

Michael J McManus
Ph: 715-389-4457

Milwaukee

Froedtert Hospital and Medical College of Wisconsin

John A Charlson
Ph: 414-805-4380

Midwest Children's Cancer Center at Children's Hospital of Wisconsin

Meghen B Browning
Ph: 414-805-4380

Australia

New South Wales
Hunter Regional Mail Centre

John Hunter Hospital

Elizabeth L Hesketh
Ph: 888-823-5923
Email: ctsucontact@westat.com

Randwick

Sydney Children's Hospital

Draga Barbaric
Ph: (02) 9382-1721

Westmead

Children's Hospital at Westmead

Geoffrey B McCowage
Ph: 61-2-9845 1400

Queensland
Herston

Royal Brisbane and Women's Hospital

Helen Irving
Ph: 888-823-5923
Email: ctsucontact@westat.com

South Brisbane

Lady Cilento Children's Hospital

Helen Irving
Ph: 888-823-5923
Email: ctsucontact@westat.com

South Australia
North Adelaide

Women's and Children's Hospital

Maria L Kirby
Ph: (08) 8161 7327
Email: cywhs.oncsec@health.sa.gov.au

Western Australia
Perth

Princess Margaret Hospital for Children

Catherine H Cole
Ph: (08) 9340 8222
Email: catherine.cole@health.wa.gov.au

Canada

Alberta
Calgary

Alberta Children's Hospital

Douglas R Strother
Ph: 403-220-6898
Email: research4kids@ucalgary.ca

British Columbia
Vancouver

Children's and Women's Hospital of British Columbia

Caron Strahlendorf
Ph: 604-875-2345ext6477

Manitoba
Winnipeg

CancerCare Manitoba

Rochelle A Yanofsky
Ph: 866-561-1026
Email: CIO_Web@cancercare.mb.ca

Newfoundland and Labrador
Saint John's

Janeway Children's Health and Rehabilitation Centre

Lisa Anne B Goodyear
Ph: 866-722-1126

Nova Scotia
Halifax

IWK Health Centre

Conrad V Fernandez
Ph: 902-470-8394

Ontario
Hamilton

McMaster Children's Hospital at Hamilton Health Sciences

Carol Portwine
Ph: 905-521-2100ext74595

Carol Portwine
Ph: 905-521-2100ext74595

Kingston

Cancer Centre of Southeastern Ontario at Kingston General Hospital

Mariana P Silva
Ph: 613-544-2630

London

Children's Hospital of Western Ontario

Shayna M Zelcer
Ph: 519-685-8306

Ottawa

Children's Hospital of Eastern Ontario

Jacqueline M Halton
Ph: 613-738-3931

Toronto

Hospital for Sick Children

Abha A Gupta
Ph: 416-946-4501
Email: clinical.trials@uhn.on.ca

Quebec
Montreal

Hopital Sainte Justine

Yvan Samson
Ph: 514-345-4931

Montreal Children's Hospital at McGill University Health Center

Sharon B Abish
Ph: 514-412-4445
Email: info@thechildren.com

Quebec

Centre de Recherche du Centre Hospitalier de l'Universite Laval

Bruno Michon
Ph: 418-525-4444

New Zealand

Christchurch

Christchurch Hospital

Siobhan F Cross
Ph: 03 364 0640

Auckland
Grafton

Starship Children's Health

Lochie R Teague
Ph: 0800 728 436

Saudi Arabia

Riyadh

King Faisal Specialist Hospital and Research Center

Afshan A Ali
Ph: 011-966-1-464-7272 ext 38005

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01231906
ClinicalTrials.gov processed this data on April 09, 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.