Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: Drugs used in chemotherapy 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.

PURPOSE: This randomized phase III trial is studying combination chemotherapy in treating patients with non-metastatic extracranial Ewing sarcoma.

Further Study Information

OBJECTIVES:

Primary

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

Secondary

• Evaluate initial volumetric tumor size as a prognostic factor for EFS in patients with localized Ewing tumors.

• Evaluate histologic response as a prognostic factor for EFS in patients with localized Ewing tumors.

• 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.

• Evaluate imaging response by FDG-positron emission tomography (PET) as a prognostic factor for EFS.

• Evaluate the effects of the type of local therapy on EFS and overall survival.

• Evaluate the effect of local surgical margins in conjunction with histologic response on EFS in patients with localized Ewing tumors.

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

OUTLINE: This is a multicenter study.

Patients are stratified according to age (≤ 17 years vs ≥ 18 years) and primary tumor site (pelvic vs non-pelvic vs extra-osseous). Patients are randomized to 1 of 2 treatment arms.

• Arm I:

• Induction therapy: Patients receive vincristine sulfate 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 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 periodically for 10 years.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Newly diagnosed extracranial, non-metastatic Ewing sarcoma or primitive neuroectodermal tumors of bone or soft tissue

• For the purpose of this study, any of the following are considered localized disease:

• Chest wall tumors with ipsilateral pleural effusions

• Ipsilateral positive pleural fluid cytology

• Ipsilateral pleural-based secondary tumor nodules

• Regional node involvement, based on clinical suspicion confirmed by pathologic documentation, are considered to be non-metastatic disease

• Tumors arising in the bony skull (extra-dural) are considered to be extracranial

• No evidence of metastatic disease, including the following:

• Lesions that are discontinuous from the primary tumor, are not regional lymph nodes, and do not share a body cavity with the primary tumor

• Contralateral pleural effusion and contralateral pleural nodules

• Distant lymph node involvement

• Pulmonary nodules that meet the following criteria:

• Solitary nodule > 0.5 cm or multiple nodules of > 0.3 cm unless biopsied and negative for Ewing sarcoma

• Biopsies of solitary nodule < 0.5 cm or multiple nodules < 3.0 cm (are not required but if performed) positive for metastatic disease

• No tumors arising in the intra-dural soft tissue

PATIENT CHARACTERISTICS:

• Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR serum creatinine based on age and/or gender as follows:

• 0.4 mg/dL (1 month to < 6 months of age)

• 0.5 mg/dL (6 months to < 1 year of age)

• 0.6 mg/dL (1 year to < 2 years of age)

• 0.8 mg/dL (2 years to < 6 years of age)

• 1.0 mg/dL (6 years to < 10 years of age)

• 1.2 mg/dL (10 years to < 13 years of age)

• 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 years to < 16 years of age)

• 1.7 mg/dL (male) or 1.4 mg/dL (female) (≥ 16 years of age)

• Total bilirubin < 1.5 times upper limit of normal (ULN)

• AST or ALT < 2.5 times ULN

• Shortening fraction of ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by radionuclide angiogram

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception for the duration of study treatment

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy or radiotherapy

• Prior biopsy of the primary tumor without an attempt at complete or partial resection allowed

• Patients are still allowed if unplanned excision was attempted or accomplished as long as adequate imaging was obtained prior to surgery

• No other concurrent chemotherapy or immunomodulating agents (including steroids unless used as an antiemetic)

• No concurrent sargramostim (GM-CSF)

Trial Contact Information

Trial Lead Organizations/Sponsors

Children's Oncology Group

Mason Bond

Principal Investigator

U.S.A.
Alabama
	Birmingham
	Children's Hospital of Alabama at University of Alabama at Birmingham
		Alyssa T Reddy	Ph: 205-934-0309
	Mobile
	University of South Alabama Mitchell Cancer Institute
		Felicia L Wilson	Ph: 251-665-8000
Arizona
	Phoenix
	Phoenix Children's Hospital
		Jessica Boklan	Ph: 602-546-0920
	Tucson
	Arizona Cancer Center at University of Arizona Health Sciences Center
		Brenda J Wittman	Ph: 520-626-9008
Arkansas
	Little Rock
	Arkansas Cancer Research Center at 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
	Loma Linda
	Loma Linda University Cancer Institute at Loma Linda University Medical Center
		Antranik A Bedros	Ph: 909-558-3375
	Los Angeles
	Childrens Hospital Los Angeles
		Leo Mascarenhas	Ph: 323-361-4110
	Mattel Children's Hospital at UCLA
		Pamela H Kempert	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
	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
		Christopher N Frantz	Ph: 302-651-5755
District of Columbia
	Washington
	Children's National Medical Center
		Jeffrey S Dome	Ph: 202-884-2549
Florida
	Fort Lauderdale
	Broward General Medical Center Cancer Center
		Hector M Rodriguez-Cortes	Ph: 954-355-5346
	Fort Myers
	Lee Cancer Care of Lee Memorial Health System
		Emad K Salman	Ph: 239-343-5333
	Gainesville
	University of Florida Shands Cancer Center
		Amy A Smith	Ph: 352-273-8675
	Hollywood
	Joe DiMaggio Children's Hospital
		Iftikhar Hanif	Ph: 954-265-2234
	Jacksonville
	Nemours Children's Clinic
		Eric S Sandler	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
	Florida Hospital Cancer Institute at Florida Hospital Orlando
		Clifford A Selsky	Ph: 407-303-5623
	M.D. Anderson Cancer Center at Orlando
		Vincent F Giusti	Ph: 321-841-7246
	Nemours Children's Clinic - Orlando
		Ramamoorthy Nagasubramanian	Ph: 407-650-7150
	Pensacola
	Nemours Children's Clinic - Pensacola
		Jeffrey H Schwartz	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
		Hardeo K Panchoosingh	Ph: 800-882-4123
Georgia
	Atlanta
	AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
		Howard M Katzenstein	Ph: 888-785-1112
	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. Martin Johnston	Ph: 912-350-8568
Hawaii
	Honolulu
	Cancer Research Center of Hawaii
		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
	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
		Ricarchito B Manera	Ph: 708-226-4357
	Oak Lawn
	Keyser Family Cancer Center at Advocate Hope Children's Hospital
		Sharad N Salvi	Ph: 847-723-7570
	Peoria
	Saint Jude Midwest Affiliate
		Pedro A De Alarcon	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: 317-274-2552
	St. Vincent Indianapolis Hospital
		Bassem I Razzouk	Ph: 317-338-2194
Iowa
	Des Moines
	Blank Children's Hospital
		Wendy L Woods-Swafford	Ph: 888-823-5923
			Email: ctsucontact@westat.com
	Iowa City
	Holden Comprehensive Cancer Center at University of Iowa
		Ayman A El-Sheikh	Ph: 800-237-1225
	Sioux City
	Mercy Medical Center - Sioux City
		Donald Bruce Wender	Ph: 712-252-0088
	Siouxland Hematology-Oncology Associates, LLP
		Donald Bruce Wender	Ph: 712-252-0088
	St. Luke's Regional Medical Center
		Donald Bruce Wender	Ph: 712-252-0088
Kentucky
	Lexington
	University of Kentucky Chandler Medical Center
		Martha F Greenwood	Ph: 859-257-3379
	Louisville
	Kosair Children's Hospital
		Salvatore J Bertolone	Ph: 866-530-5516
Louisiana
	New Orleans
	Ochsner Cancer Institute at Ochsner Clinic Foundation
		Rajasekharan P. Warrier	Ph: 504-894-5377
Maine
	Bangor
	CancerCare of Maine at Eastern Maine Medical Center
		Sarah J Fryberger	Ph: 207-973-4274
Maryland
	Baltimore
	Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
		Joseph M Wiley	Ph: 410-601-6120
			Email: pridgely@lifebridgehealth.org
	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
		David M Loeb	Ph: 410-955-8804
			Email: jhcccro@jhmi.edu
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
	Worcester
	UMASS Memorial Cancer Center - University Campus
		Christopher P Keuker	Ph: 508-856-2464
			Email: laura.lefko@umassmed.edu
Michigan
	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
	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
	Lansing
	Breslin Cancer Center at Ingham Regional Medical Center
		Renuka Gera	Ph: 517-334-2765
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
	Ellis Fischel Cancer Center at University of Missouri - Columbia
		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: 409-772-1950
Nevada
	Las Vegas
	CCOP - Nevada Cancer Research Foundation
		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
		Burton E Appel	Ph: 201-996-2879
	Livingston
	St. Barnabas Medical Center Cancer Center
		Stacey Rifkin-Zenenberg	Ph: 973-926-7230
	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
	Paterson
	St. Joseph's Hospital and Medical Center
		Mary A Bonilla	Ph: 973-754-2909
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
		Rosanna J Ricafort	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
	Mount Sinai Medical Center
		Birte Wistinghausen	Ph: 212-824-7320
			Email: jenny.figueroa@mssm.edu
	New York University Medical Center
		Elizabeth A Raetz	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
		Mehmet F Ozkaynak	Ph: 914-594-3794
North Carolina
	Asheville
	Mission Hospitals - Memorial Campus
		Orren Beaty	Ph: 828-213-4150
	Chapel Hill
	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
		Stuart H Gold	Ph: 877-668-0683
	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
		Nathan L Kobrinsky	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
		Tanya M Tekautz	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
		Laura T Martin	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
Oklahoma
	Oklahoma City
	Oklahoma University Cancer Institute
		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
Pennsylvania
	Bethlehem
	Lehigh Valley Hospital - Muhlenberg
		Philip M Monteleone	Ph: 484-884-2201
	Danville
	Geisinger Cancer Institute at Geisinger Health
		Jeffrey S Taylor	Ph: 570-271-5251
	Hershey
	Penn State Children's Hospital
		Lisa M McGregor	Ph: 717-531-6012
	Philadelphia
	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
Rhode Island
	Providence
	Rhode Island Hospital Comprehensive Cancer Center
		Cindy L Schwartz	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
		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
		Wayne L Furman	Ph: 901-595-4644
	Nashville
	Vanderbilt-Ingram Cancer Center
		Scott C Borinstein	Ph: 800-811-8480
Texas
	Austin
	Dell Children's Medical Center of Central Texas
		Sharon K Lockhart	Ph: 512-324-8022
	Corpus Christi
	Driscoll Children's Hospital
		M. Cris 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
		Naomi J Winick	Ph: 214-648-7097
	Fort Worth
	Cook Children's Medical Center - Fort Worth
		Mary Meaghan P Granger	Ph: 682-885-2103
	Houston
	Dan L. Duncan Cancer Center at Baylor College of Medicine
		Lisa R Bomgaars	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
		Najat C Daw	Ph: 713-792-3245
	San Antonio
	University of Texas Health Science Center at San Antonio
		Anne-Marie R Langevin	Ph: 210-567-0653
			Email: che@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
	Vermont Cancer Center at University of Vermont
		Alan C Homans	Ph: 802-656-8990
Virginia
	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
	Richmond
	Virginia Commonwealth University Massey Cancer Center
		Kamar Godder	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: 888-823-5923
			Email: ctsucontact@westat.com
West Virginia
	Charleston
	West Virginia University Medical School - Charleston
		Allen R Chauvenet	Ph: 304-388-9944
Wisconsin
	Madison
	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
		Kenneth B De Santes	Ph: 608-262-5223
	Marshfield
	Marshfield Clinic - Marshfield Center
		Michael J McManus	Ph: 715-389-4457
	Milwaukee
	Froedtert Hospital and Medical College of Wisconsin
		Timothy S Fenske	Ph: 414-805-4380
	Midwest Children's Cancer Center at Children's Hospital of Wisconsin
		Michael E Kelly	Ph: 414-805-4380
Australia
New South Wales
	Randwick
	Sydney Children's Hospital
		Draga Barbaric	Ph: (02) 9382-1721
	Sydney
	Children's Hospital at Westmead
		Geoffrey B McCowage	Ph: 61-2-9845 1400
Queensland
	Herston
	Royal 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 8330
			Email: admin@childcancerresearch.com.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
		Margaret C Yhap	Ph: 902-470-8394
Ontario
	Hamilton
	McMaster Children's Hospital at Hamilton Health Sciences
		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
		Anne E Cairney	Ph: 519-685-8306
	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
	Ste-Foy
	Centre de Recherche du Centre Hospitalier de l'Universite Laval
		Bruno Michon	Ph: 418-525-4444
Saskatchewan
	Regina
	Allan Blair Cancer Centre at Pasqua Hospital
		Mansoor M Haq	Ph: 306-766-2213
	Saskatoon
	Saskatoon Cancer Centre at the University of Saskatchewan
		Christopher Mpofu	Ph: 306-655-2914

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01231906
Information obtained from ClinicalTrials.gov on November 26, 2012

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