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

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Status: Temporarily Closed to Accrual

Description

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 extracranial Ewing sarcoma that has not spread from the primary site to other places in the body. 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, by stopping them from dividing, or by stopping them from spreading. 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.

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

Locations & Contacts

Alabama

Birmingham
Children's Hospital of Alabama
Status: Temporarily closed to accrual
Contact: Alyssa Terry Reddy
Phone: 205-638-9285
University of Alabama at Birmingham Cancer Center
Status: Temporarily closed to accrual
Contact: Alyssa Terry Reddy
Phone: 205-638-9285

Alaska

Anchorage
Providence Alaska Medical Center
Status: Temporarily closed to accrual
Contact: Benjamin Buckner Bridges
Phone: 208-381-3376 Email: mcdonagd@slhs.org

Arizona

Phoenix
Phoenix Childrens Hospital
Status: Temporarily closed to accrual
Contact: Jessica Boklan
Phone: 602-546-0920
Tucson
The University of Arizona Medical Center-University Campus
Status: Temporarily closed to accrual
Contact: Lisa M. Kopp
Phone: 520-626-9008

Arkansas

Little Rock
Arkansas Children's Hospital
Status: Temporarily closed to accrual
Contact: David L. Becton
Phone: 501-364-7373

California

Downey
Southern California Permanente Medical Group
Status: Temporarily closed to accrual
Contact: Robert Michael Cooper
Phone: 626-564-3455
Duarte
City of Hope Comprehensive Cancer Center
Status: Temporarily closed to accrual
Contact: Anna Beata Pawlowska
Phone: 800-826-4673 Email: becomingapatient@coh.org
Long Beach
Miller Children's and Women's Hospital Long Beach
Status: Temporarily closed to accrual
Contact: Pamela Helen-Heilge Kempert
Phone: 562-933-5600
Los Angeles
Cedars Sinai Medical Center
Status: Temporarily closed to accrual
Contact: Fataneh (Fae) Majlessipour
Phone: 310-423-8965
Children's Hospital Los Angeles
Status: Temporarily closed to accrual
Contact: Leo Mascarenhas
Phone: 323-361-4110
Los Angeles County-USC Medical Center
Status: Temporarily closed to accrual
Contact: James Shun Dah Hu
Phone: 323-865-0451
Mattel Children's Hospital UCLA
Status: Temporarily closed to accrual
Contact: Noah C. Federman
Phone: 310-825-6708
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Contact: Pamela Helen-Heilge Kempert
Phone: 310-825-6708
USC / Norris Comprehensive Cancer Center
Status: Temporarily closed to accrual
Contact: James Shun Dah Hu
Phone: 323-865-0451
Madera
Children's Hospital Central California
Status: Temporarily closed to accrual
Contact: Vonda Lee Crouse
Phone: 866-353-5437
Oakland
Children's Hospital and Research Center at Oakland
Status: Temporarily closed to accrual
Contact: Carla Barbara Golden
Phone: 510-450-7600
Kaiser Permanente-Oakland
Status: Temporarily closed to accrual
Contact: Steven K. Bergstrom
Phone: 626-564-3455
Orange
Children's Hospital of Orange County
Status: Temporarily closed to accrual
Contact: Elyssa M. Rubin
Phone: 714-997-3000
Palo Alto
Lucile Packard Children's Hospital Stanford University
Status: Temporarily closed to accrual
Contact: Sheri Lee Spunt
Phone: 650-498-7061 Email: ccto-office@stanford.edu
Sacramento
Sutter Medical Center Sacramento
Status: Temporarily closed to accrual
Contact: Yung Soon Yim
Phone: 415-209-2686 Email: bernicl@sutterhealth.org
University of California Davis Comprehensive Cancer Center
Status: Temporarily closed to accrual
Contact: Marcio Henrique Malogolowkin
Phone: 916-734-3089
San Diego
Rady Children's Hospital - San Diego
Status: Temporarily closed to accrual
Contact: William D. Roberts
Phone: 858-966-5934
San Francisco
UCSF Medical Center-Mission Bay
Status: Temporarily closed to accrual
Contact: Robert Edward Goldsby
Phone: 877-827-3222

Colorado

Aurora
Children's Hospital Colorado
Status: Temporarily closed to accrual
Contact: Timothy Price Garrington
Phone: 720-777-6672
Denver
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Status: Temporarily closed to accrual
Contact: Jennifer Jocelyn Clark
Phone: 866-775-6246

Connecticut

Hartford
Connecticut Children's Medical Center
Status: Temporarily closed to accrual
Contact: Michael Scott Isakoff
Phone: 860-545-9981
New Haven
Yale University
Status: Temporarily closed to accrual
Contact: Nina Singh Kadan-Lottick
Phone: 203-785-5702

Delaware

Wilmington
Alfred I duPont Hospital for Children
Status: Temporarily closed to accrual
Contact: Scott M. Bradfield
Phone: 904-697-3529

District of Columbia

Washington
Children's National Medical Center
Status: Temporarily closed to accrual
Contact: Jeffrey Stuart Dome
Phone: 202-884-2549
MedStar Georgetown University Hospital
Status: Temporarily closed to accrual
Contact: Corina Elena Gonzalez
Phone: 202-444-2223

Florida

Fort Lauderdale
Broward Health Medical Center
Status: Temporarily closed to accrual
Contact: Hector M. Rodriguez-Cortes
Phone: 954-355-5346
Fort Myers
Golisano Children's Hospital of Southwest Florida
Status: Temporarily closed to accrual
Contact: Emad K. Salman
Phone: 239-343-5333
Gainesville
University of Florida Health Science Center �� Gainesville
Status: Temporarily closed to accrual
Contact: William Birdsall Slayton
Phone: 352-273-8675 Email: trials@cancer.ufl.edu
Hollywood
Memorial Regional Hospital / Joe DiMaggio Children's Hospital
Status: Temporarily closed to accrual
Contact: Iftikhar Hanif
Phone: 954-265-2234
Jacksonville
Nemours Children's Clinic-Jacksonville
Status: Temporarily closed to accrual
Contact: Scott M. Bradfield
Phone: 904-697-3529
Miami
Baptist Hospital of Miami
Status: Temporarily closed to accrual
Contact: Doured Daghistani
Phone: 800-599-2456 Email: cancerinfo@baptisthealth.net
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: Temporarily closed to accrual
Contact: Julio Cesar Barredo
Phone: 305-243-2647
Orlando
Arnold Palmer Hospital for Children
Status: Temporarily closed to accrual
Contact: Vincent Ferdinando Giusti
Phone: 321-843-2584
Florida Hospital Orlando
Status: Temporarily closed to accrual
Contact: Fouad M. Hajjar
Phone: 407-303-2090 Email: FH.Cancer.Research@flhosp.org
Nemours Children's Hospital
Status: Temporarily closed to accrual
Contact: Scott M. Bradfield
Phone: 904-697-3529
UF Cancer Center at Orlando Health
Status: Temporarily closed to accrual
Contact: Vincent Ferdinando Giusti
Phone: 321-843-2584
Pensacola
Nemours Children's Clinic - Pensacola
Status: Temporarily closed to accrual
Contact: Scott M. Bradfield
Phone: 904-697-3529
Saint Petersburg
Johns Hopkins All Children's Hospital
Status: Temporarily closed to accrual
Contact: Jonathan Layne Metts Email: helpdesk@childrensoncologygroup.org
Tampa
Saint Joseph's Hospital / Children's Hospital-Tampa
Status: Temporarily closed to accrual
Contact: Mark J. Mogul
Phone: 800-882-4123
West Palm Beach
Saint Mary's Hospital
Status: Temporarily closed to accrual
Contact: Narayana Gowda
Phone: 561-881-2815

Georgia

Augusta
Augusta University Medical Center
Status: Temporarily closed to accrual
Contact: Colleen H. McDonough
Phone: 706-721-1663 Email: cancer@augusta.edu
Savannah
Memorial University Medical Center
Status: Temporarily closed to accrual
Contact: J. Martin Johnston
Phone: 912-350-8568

Hawaii

Honolulu
Kapiolani Medical Center for Women and Children
Status: Temporarily closed to accrual
Contact: Wade T. Kyono
Phone: 808-983-6090
Straub Clinic and Hospital
Status: Temporarily closed to accrual
Contact: Wade T. Kyono
Phone: 808-983-6090

Idaho

Boise
Saint Luke's Mountain States Tumor Institute
Status: Temporarily closed to accrual
Contact: Benjamin Buckner Bridges
Phone: 208-381-3376 Email: mcdonagd@slhs.org

Illinois

Chicago
Lurie Children's Hospital-Chicago
Status: Temporarily closed to accrual
Contact: David O. Walterhouse
Phone: 773-880-4562
University of Illinois
Status: Temporarily closed to accrual
Contact: Mary Lou Schmidt
Phone: 312-355-3046
Maywood
Loyola University Medical Center
Status: Temporarily closed to accrual
Contact: Eugene Suh
Phone: 708-226-4357
Oak Lawn
Advocate Children's Hospital-Oak Lawn
Status: Temporarily closed to accrual
Contact: Rebecca Erin McFall
Phone: 847-723-7570
Park Ridge
Advocate Children's Hospital-Park Ridge
Status: Temporarily closed to accrual
Contact: Caroline Yingwen Hu
Phone: 847-723-9472
Peoria
Saint Jude Midwest Affiliate
Status: Temporarily closed to accrual
Contact: Pedro A. De Alarcon
Phone: 309-655-3258
Springfield
Memorial Medical Center
Status: Temporarily closed to accrual
Contact: Gregory P. Brandt
Phone: 217-545-7929
Saint John's Hospital
Status: Temporarily closed to accrual
Contact: Gregory P. Brandt
Phone: 217-545-7929
Southern Illinois University School of Medicine
Status: Temporarily closed to accrual
Contact: Gregory P. Brandt
Phone: 217-545-7929

Indiana

Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: Temporarily closed to accrual
Contact: Robert J. Fallon
Phone: 800-248-1199
Riley Hospital for Children
Status: Temporarily closed to accrual
Contact: Robert J. Fallon
Phone: 800-248-1199
Saint Vincent Hospital and Health Care Center
Status: Temporarily closed to accrual
Contact: Bassem I. Razzouk
Phone: 317-338-2194 Email: research@stvincent.org

Iowa

Des Moines
Blank Children's Hospital
Status: Temporarily closed to accrual
Contact: Wendy Leigh Woods-Swafford
Phone: 515-241-6729
Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: Temporarily closed to accrual
Contact: Mariko Sato
Phone: 800-237-1225

Kentucky

Lexington
University of Kentucky / Markey Cancer Center
Status: Temporarily closed to accrual
Contact: Lars Martin Wagner
Phone: 859-257-3379

Louisiana

New Orleans
Children's Hospital New Orleans
Status: Temporarily closed to accrual
Contact: Lolie C. Yu
Phone: 504-894-5377
Ochsner Medical Center Jefferson
Status: Temporarily closed to accrual
Contact: Craig Lotterman
Phone: 888-562-4763

Maine

Bangor
Eastern Maine Medical Center
Status: Temporarily closed to accrual
Contact: Sam Wei Lew
Phone: 800-987-3005
Scarborough
Maine Children's Cancer Program
Status: Temporarily closed to accrual
Contact: Aaron Robert Weiss
Phone: 207-396-7565

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: Temporarily closed to accrual
Contact: David M. Loeb
Phone: 410-955-8804 Email: jhcccro@jhmi.edu
Sinai Hospital of Baltimore
Status: Temporarily closed to accrual
Contact: Jason M. Fixler
Phone: 410-601-6120 Email: pridgely@lifebridgehealth.org
University of Maryland / Greenebaum Cancer Center
Status: Temporarily closed to accrual
Contact: Teresa Anne York
Phone: 800-888-8823
Bethesda
Walter Reed National Military Medical Center
Status: Temporarily closed to accrual
Contact: Anne Benedicta Warwick
Phone: 301-319-2100

Massachusetts

Boston
Massachusetts General Hospital Cancer Center
Status: Temporarily closed to accrual
Contact: Howard Jeffrey Weinstein
Phone: 877-726-5130
Springfield
Baystate Medical Center
Status: Temporarily closed to accrual
Contact: Joanna G. Luty
Phone: 413-794-3565 Email: tamara.wrenn@baystatehealth.org
Worcester
University of Massachusetts Medical School
Status: Temporarily closed to accrual
Contact: Christopher P. Keuker
Phone: 508-856-3216 Email: cancer.research@umassmed.edu

Michigan

Ann Arbor
C S Mott Children's Hospital
Status: Temporarily closed to accrual
Contact: Brenda Joyce Kitchen
Phone: 248-551-7695
Detroit
Saint John Hospital and Medical Center
Status: Temporarily closed to accrual
Contact: Hadi Sawaf
Phone: 313-343-3166
Wayne State University / Karmanos Cancer Institute
Status: Temporarily closed to accrual
Contact: Roland L. Chu
Phone: 313-576-9363
Grand Rapids
Helen DeVos Children's Hospital at Spectrum Health
Status: Temporarily closed to accrual
Contact: David Scott Dickens
Phone: 616-391-1230 Email: crcwm-regulatory@crcwm.org
Kalamazoo
Bronson Methodist Hospital
Status: Temporarily closed to accrual
Contact: Katharina Elisabeth Elliott
Phone: 616-391-1230 Email: crcwm-regulatory@crcwm.org
Royal Oak
Beaumont Children's Hospital-Royal Oak
Status: Temporarily closed to accrual
Contact: Laura Kate Gowans
Phone: 248-551-7695

Minnesota

Minneapolis
University of Minnesota / Masonic Cancer Center
Status: Temporarily closed to accrual
Contact: Brenda J. Weigel
Phone: 612-624-2620
Rochester
Mayo Clinic
Status: Temporarily closed to accrual
Contact: Nadia Nicole Laack
Phone: 855-776-0015

Missouri

Columbia
Columbia Regional
Status: Temporarily closed to accrual
Contact: Thomas Ward Loew
Phone: 800-237-1225
Saint Louis
Mercy Hospital Saint Louis
Status: Temporarily closed to accrual
Contact: Bethany Graham Sleckman
Phone: 913-948-5588
Washington University School of Medicine
Status: Temporarily closed to accrual
Contact: Frederick Szujuei Huang
Phone: 800-600-3606 Email: info@siteman.wustl.edu

Nebraska

Omaha
Children's Hospital and Medical Center of Omaha
Status: Temporarily closed to accrual
Contact: Minnie Abromowitch
Phone: 402-955-3949
University of Nebraska Medical Center
Status: Temporarily closed to accrual
Contact: Minnie Abromowitch
Phone: 402-955-3949

Nevada

Las Vegas
Children's Specialty Center of Nevada II
Status: Temporarily closed to accrual
Contact: Alan K. Ikeda
Phone: 702-384-0013
Nevada Cancer Research Foundation CCOP
Status: Active
Contact: Jonathan Bernstein
Phone: 702-384-0013
Summerlin Hospital Medical Center
Status: Temporarily closed to accrual
Contact: Alan K. Ikeda
Phone: 702-384-0013
Sunrise Hospital and Medical Center
Status: Temporarily closed to accrual
Contact: Alan K. Ikeda
Phone: 702-384-0013
University Medical Center of Southern Nevada
Status: Temporarily closed to accrual
Contact: Alan K. Ikeda
Phone: 702-384-0013
Reno
Saint Mary's Regional Medical Center
Status: Temporarily closed to accrual
Contact: Alan K. Ikeda
Phone: 702-384-0013

New Hampshire

Lebanon
Dartmouth Hitchcock Medical Center
Status: Temporarily closed to accrual
Contact: Sara Chaffee
Phone: 800-639-6918 Email: cancer.research.nurse@dartmouth.edu

New Jersey

Hackensack
Hackensack University Medical Center
Status: Temporarily closed to accrual
Contact: Michael Bertram Harris
Phone: 201-996-2879
Livingston
Saint Barnabas Medical Center
Status: Temporarily closed to accrual
Contact: Stacey Rifkin-Zenenberg
Phone: 201-996-2879
Morristown
Morristown Medical Center
Status: Temporarily closed to accrual
Contact: Steven Lon Halpern
Phone: 973-971-5900
New Brunswick
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
Status: Temporarily closed to accrual
Contact: Richard A. Drachtman
Phone: 732-235-8675
Saint Peter's University Hospital
Status: Temporarily closed to accrual
Contact: Nibal Ahmad Zaghloul
Phone: 732-745-8600ext6163 Email: kcovert@saintpetersuh.com
Paterson
Saint Joseph's Regional Medical Center
Status: Temporarily closed to accrual
Contact: Mary Ann Bonilla
Phone: 973-754-2909

New Mexico

Albuquerque
University of New Mexico Cancer Center
Status: Temporarily closed to accrual
Contact: Koh B. Boayue
Phone: 505-925-0366 Email: LByatt@nmcca.org

New York

Albany
Albany Medical Center
Status: Temporarily closed to accrual
Contact: Vikramjit Singh Kanwar
Phone: 518-262-3368
Bronx
Montefiore Medical Center - Moses Campus
Status: Temporarily closed to accrual
Contact: Lisa Figueiredo
Phone: 718-904-2730 Email: aecc@aecom.yu.edu
New Hyde Park
The Steven and Alexandra Cohen Children's Medical Center of New York
Status: Temporarily closed to accrual
Contact: Carolyn Fein Levy
Phone: 718-470-3470 Email: clevy4@northwell.edu
New York
Columbia University / Herbert Irving Cancer Center
Status: Temporarily closed to accrual
Contact: Alice Lee
Phone: 212-305-8615
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: Temporarily closed to accrual
Contact: Sharon Leigh Gardner
Phone: 212-263-4434 Email: prmc.coordinator@nyumc.org
Mount Sinai Hospital
Status: Temporarily closed to accrual
Contact: Birte Wistinghausen
Phone: 212-824-7309 Email: CCTO@mssm.edu
Stony Brook
Stony Brook University Medical Center
Status: Temporarily closed to accrual
Contact: Robert Ingalls Parker
Phone: 800-862-2215
Syracuse
State University of New York Upstate Medical University
Status: Temporarily closed to accrual
Contact: Philip M. Monteleone
Phone: 315-464-5476
Valhalla
New York Medical College
Status: Temporarily closed to accrual
Contact: Jessica Cassara Hochberg
Phone: 914-594-3794

North Carolina

Asheville
Mission Hospital-Memorial Campus
Status: Temporarily closed to accrual
Contact: Douglas James Scothorn
Phone: 828-213-4150
Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: Temporarily closed to accrual
Contact: Stuart Harrison Gold
Phone: 877-668-0683 Email: cancerclinicaltrials@med.unc.edu
Charlotte
Novant Health Presbyterian Medical Center
Status: Temporarily closed to accrual
Contact: Paulette Charese Bryant
Phone: 704-384-5369
Durham
Duke University Medical Center
Status: Temporarily closed to accrual
Contact: Susan G. Kreissman
Phone: 888-275-3853
Winston-Salem
Wake Forest University Health Sciences
Status: Temporarily closed to accrual
Contact: Thomas Bennett Russell
Phone: 336-713-6771

North Dakota

Fargo
Sanford Broadway Medical Center
Status: Temporarily closed to accrual
Contact: Samuel Odame Anim
Phone: 701-234-6161

Ohio

Akron
Children's Hospital Medical Center of Akron
Status: Temporarily closed to accrual
Contact: Steven J. Kuerbitz
Phone: 330-543-3193
Cincinnati
Cincinnati Children's Hospital Medical Center
Status: Temporarily closed to accrual
Contact: Joseph G. Pressey
Phone: 513-636-2799
Cleveland
Cleveland Clinic Foundation
Status: Temporarily closed to accrual
Contact: Aron Flagg
Phone: 866-223-8100
Rainbow Babies and Childrens Hospital
Status: Temporarily closed to accrual
Contact: Yousif (Joe) H. Matloub
Phone: 216-844-5437
Columbus
Nationwide Children's Hospital
Status: Temporarily closed to accrual
Contact: Mark Anthony Ranalli
Phone: 614-722-2708
Dayton
Dayton Children's Hospital
Status: Temporarily closed to accrual
Contact: Ayman Aly El-Sheikh
Phone: 800-228-4055
Toledo
Mercy Children's Hospital
Status: Temporarily closed to accrual
Contact: Rama Jasty
Phone: 800-865-1125
The Toledo Hospital / Toledo Children's Hospital
Status: Temporarily closed to accrual
Contact: Dagmar Tichy Stein
Phone: 419-824-1842

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: Temporarily closed to accrual
Contact: Rene Yvonne McNall-Knapp
Phone: 405-271-8777 Email: ou-clinical-trials@ouhsc.edu
Tulsa
Natalie Warren Bryant Cancer Center at Saint Francis
Status: Temporarily closed to accrual
Contact: Gregory Brian Kirkpatrick
Phone: 918-494-2200

Oregon

Portland
Legacy Emanuel Children's Hospital
Status: Temporarily closed to accrual
Contact: Janice Faye Olson
Phone: 503-413-2560
Oregon Health and Science University
Status: Temporarily closed to accrual
Contact: Suman Malempati
Phone: 503-494-1080 Email: trials@ohsu.edu
Providence Saint Vincent Medical Center
Status: Temporarily closed to accrual
Contact: Keith S. Lanier
Phone: 503-215-2614 Email: CanRsrchStudies@providence.org

Pennsylvania

Bethlehem
Lehigh Valley Hospital - Muhlenberg
Status: Temporarily closed to accrual
Contact: Lydia Alberta Boateng
Phone: 484-884-2201
Danville
Geisinger Medical Center
Status: Temporarily closed to accrual
Contact: Jagadeesh Ramdas
Phone: 570-271-5251
Hershey
Penn State Children's Hospital
Status: Temporarily closed to accrual
Contact: Lisa MacNabb McGregor
Phone: 717-531-6012
Philadelphia
Children's Hospital of Philadelphia
Status: Temporarily closed to accrual
Contact: Richard Berry Womer
Phone: 215-590-2810
Fox Chase Cancer Center
Status: Temporarily closed to accrual
Contact: Margaret von Mehren
Phone: 215-728-4790
Pittsburgh
Children's Hospital of Pittsburgh of UPMC
Status: Temporarily closed to accrual
Contact: Michael R. Wollman
Phone: 412-692-5573

Puerto Rico

San Juan
San Jorge Children's Hospital
Status: Temporarily closed to accrual
Contact: Luis A. Clavell
Phone: 787-727-1000

Rhode Island

Providence
Rhode Island Hospital
Status: Temporarily closed to accrual
Contact: Jennifer J. Greene Welch
Phone: 401-444-1488

South Carolina

Charleston
Medical University of South Carolina
Status: Temporarily closed to accrual
Contact: Jacqueline M. Kraveka
Phone: 843-792-9321
Columbia
Palmetto Health Richland
Status: Temporarily closed to accrual
Contact: Stuart Louis Cramer
Phone: 205-934-0309
Greenville
BI-LO Charities Children's Cancer Center
Status: Temporarily closed to accrual
Contact: Nichole Leigh Bryant
Phone: 864-241-6251

South Dakota

Sioux Falls
Sanford USD Medical Center - Sioux Falls
Status: Temporarily closed to accrual
Contact: Kayelyn Jean Wagner
Phone: 605-328-1367

Tennessee

Chattanooga
T C Thompson Children's Hospital
Status: Temporarily closed to accrual
Contact: Manoo G. Bhakta
Phone: 865-331-1812
Nashville
Vanderbilt University / Ingram Cancer Center
Status: Temporarily closed to accrual
Contact: Scott C. Borinstein
Phone: 800-811-8480

Texas

Austin
Dell Children's Medical Center of Central Texas
Status: Temporarily closed to accrual
Contact: Amy Catherine Fowler
Phone: 214-648-7097
Corpus Christi
Driscoll Children's Hospital
Status: Temporarily closed to accrual
Contact: Nkechi Ifeoma Mba
Phone: 361-694-5311
Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: Temporarily closed to accrual
Contact: Patrick J. Leavey
Phone: 214-648-7097
El Paso
El Paso Children's Hospital
Status: Temporarily closed to accrual
Contact: Lisa Louise Rubin Hartman
Phone: 915-298-5444 Email: lisa.hartman@ttuhsc.edu
Fort Worth
Cook Children's Medical Center
Status: Temporarily closed to accrual
Contact: Lauren Jean Akers
Phone: 682-885-2103
Houston
Baylor College of Medicine / Dan L Duncan Comprehensive Cancer Center
Status: Temporarily closed to accrual
Contact: Timothy C. Griffin
Phone: 800-248-1199
M D Anderson Cancer Center
Status: Temporarily closed to accrual
Contact: Cynthia E. Herzog
Phone: 713-792-3245
Lubbock
Covenant Children's Hospital
Status: Temporarily closed to accrual
Contact: Kishor Mallikarjun Bhende
Phone: 806-775-8590
San Antonio
Children's Hospital of San Antonio
Status: Temporarily closed to accrual
Contact: Lisa Lynn Wang
Phone: 713-798-1354 Email: burton@bcm.edu
Methodist Children's Hospital of South Texas
Status: Temporarily closed to accrual
Contact: Vinod Kumar Gidvani-Diaz
Phone: 210-575-7000
University of Texas Health Science Center at San Antonio
Status: Temporarily closed to accrual
Contact: Anne-Marie R. Langevin
Phone: 210-450-3800 Email: CTO@uthscsa.edu

Virginia

Charlottesville
University of Virginia Cancer Center
Status: Temporarily closed to accrual
Contact: Kimberly Panter Dunsmore
Phone: 434-243-6322 Email: JME3D@hscmail.mcc.virginia.edu
Falls Church
Inova Fairfax Hospital
Status: Temporarily closed to accrual
Contact: Marshall A. Schorin
Phone: 703-208-6650 Email: Stephanie.VanBebber@inova.org
Norfolk
Childrens Hospital-King's Daughters
Status: Temporarily closed to accrual
Contact: Eric Jeffrey Lowe
Phone: 757-668-7243
Portsmouth
Naval Medical Center - Portsmouth
Status: Temporarily closed to accrual
Contact: Bethany Michelle Mikles
Phone: 757-953-5939
Richmond
Virginia Commonwealth University / Massey Cancer Center
Status: Temporarily closed to accrual
Contact: Gita Vasers Massey
Phone: 804-628-1939
Roanoke
Carilion Clinic Children's Hospital
Status: Temporarily closed to accrual
Contact: Mandy Meck Atkinson
Phone: 540-981-7376

Washington

Seattle
Seattle Children's Hospital
Status: Temporarily closed to accrual
Contact: Douglas S. Hawkins
Phone: 866-987-2000
Spokane
Providence Sacred Heart Medical Center and Children's Hospital
Status: Temporarily closed to accrual
Contact: Judy L. Felgenhauer
Phone: 800-228-6618 Email: HopeBeginsHere@providence.org
Tacoma
Madigan Army Medical Center
Status: Temporarily closed to accrual
Contact: Melissa Anne Forouhar
Phone: 253-968-0129 Email: mamcdci@amedd.army.mil
Mary Bridge Children's Hospital and Health Center
Status: Temporarily closed to accrual
Contact: Robert G. Irwin
Phone: 800-552-1419

West Virginia

Bridgeport
United Hospital Center
Status: Temporarily closed to accrual
Contact: Stephan R. Paul
Phone: 304-293-7374 Email: cancertrialsinfo@hsc.wvu.edu
Charleston
West Virginia University Charleston
Status: Temporarily closed to accrual
Contact: Ashley E. Meyer
Phone: 304-388-9944
Morgantown
West Virginia University Healthcare
Status: Temporarily closed to accrual
Contact: Stephan R. Paul
Phone: 304-293-7374 Email: cancertrialsinfo@hsc.wvu.edu
Parkersburg
Camden-Clark Memorial Hospital
Status: Temporarily closed to accrual
Contact: Stephan R. Paul
Phone: 304-293-7374 Email: cancertrialsinfo@hsc.wvu.edu

Wisconsin

Green Bay
Saint Vincent Hospital Cancer Center Green Bay
Status: Temporarily closed to accrual
Contact: John Robert Hill
Phone: 920-433-8889 Email: Christy.Gilchrist@hshs.org
Madison
University of Wisconsin Hospital and Clinics
Status: Temporarily closed to accrual
Contact: Kenneth Brian De Santes
Phone: 715-422-7718
Marshfield
Marshfield Clinic
Status: Temporarily closed to accrual
Contact: Michael John McManus
Phone: 715-389-4457
Milwaukee
Children's Hospital of Wisconsin
Status: Temporarily closed to accrual
Contact: Meghen B. Browning
Phone: 414-805-4380

Alberta

Edmonton
University of Alberta Hospital
Status: Temporarily closed to accrual
Contact: Sunil Jayantilal Sunderlal Desai
Phone: 780-407-8798

Ontario

Ottawa
Children's Hospital of Eastern Ontario
Status: Temporarily closed to accrual
Contact: Donna Lynn Johnston
Phone: 613-738-3931
Toronto
Hospital for Sick Children
Status: Temporarily closed to accrual
Contact: Abha Anshu Gupta Email: clinical.trials@uhn.on.ca

Quebec

Quebec
Centre Hospitalier Universitaire de Quebec
Status: Temporarily closed to accrual
Contact: Bruno Michon
Phone: 418-525-4444

Australia

Herston
Royal Brisbane and Women's Hospital
Status: Temporarily closed to accrual
Contact: Helen Irving
Phone: 1300 762 831
Royal Children's Hospital-Brisbane
Status: Temporarily closed to accrual
Contact: Helen Irving
Phone: 1300 762 831
Hunter Regional Mail Centre
John Hunter Children's Hospital
Status: Temporarily closed to accrual
Contact: Draga Barbaric
Phone: (02) 9382-1721
South Brisbane
Lady Cilento Children's Hospital
Status: Temporarily closed to accrual
Contact: Helen Irving
Phone: 1300 762 831

New Zealand

Grafton
Starship Children's Hospital
Status: Temporarily closed to accrual
Contact: Mark Andrew Winstanley
Phone: +0800 728 436

Trial Objectives and Outline

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.

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Treatment

Lead Organization

Lead Organization
Childrens Oncology Group

Principal Investigator
Patrick J. Leavey

Trial IDs

Primary ID AEWS1031
Secondary IDs NCI-2011-02611, CDR0000687639, COG-AEWS1031
Clinicaltrials.gov ID NCT01231906