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

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

Alaska

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

Arizona

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

Arkansas

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

California

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

Colorado

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

Connecticut

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

Delaware

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

District of Columbia

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

Florida

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

Georgia

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

Hawaii

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

Idaho

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

Illinois

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

Indiana

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

Iowa

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

Kentucky

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

Louisiana

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

Maine

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

Maryland

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

Massachusetts

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

Michigan

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

Minnesota

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

Missouri

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

Nebraska

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

Nevada

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

New Hampshire

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

New Jersey

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

New Mexico

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

New York

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

North Carolina

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

North Dakota

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

Ohio

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

Oklahoma

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

Oregon

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

Pennsylvania

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

Puerto Rico

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

Rhode Island

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

South Carolina

BI-LO Charities Children's Cancer Center
Status: Temporarily closed to accrual
Greenville, South Carolina
Contact: Nichole Leigh Bryant
Phone: 864-241-6251
Medical University of South Carolina
Status: Temporarily closed to accrual
Charleston, South Carolina
Contact: Jacqueline M. Kraveka
Phone: 843-792-9321
Palmetto Health Richland
Status: Temporarily closed to accrual
Columbia, South Carolina
Contact: Ronnie W. Neuberg
Phone: 803-434-3680

South Dakota

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

Tennessee

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

Texas

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

Virginia

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

Washington

Madigan Army Medical Center
Status: Temporarily closed to accrual
Tacoma, Washington
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
Tacoma, Washington
Contact: Robert G. Irwin
Phone: 800-552-1419
Providence Sacred Heart Medical Center and Children's Hospital
Status: Temporarily closed to accrual
Spokane, Washington
Contact: Judy L. Felgenhauer
Phone: 800-228-6618 Email: HopeBeginsHere@providence.org
Seattle Children's Hospital
Status: Temporarily closed to accrual
Seattle, Washington
Contact: Douglas S. Hawkins
Phone: 866-987-2000

West Virginia

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

Wisconsin

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

Alberta

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

Ontario

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

Quebec

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

Australia

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

New Zealand

Starship Children's Hospital
Status: Temporarily closed to accrual
Grafton, Auckland
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

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