Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation, Radiation Therapy, and/or Surgery in Treating Patients With Ewing's Sarcoma

June 23, 2014 updated by: University of Leicester

European Ewing Tumour Working Initiative of National Groups Ewing Tumour Studies 1999 (EURO-E.W.I.N.G.99)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and kill more tumor cells. It is not yet known if combination chemotherapy is more effective with or without radiation therapy and/or surgery in treating Ewing's sarcoma.

PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens to see how well they work when given with or without peripheral stem cell transplantation, radiation therapy, and/or surgery in treating patients with Ewing's sarcoma.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Compare the event-free and overall survival of patients with tumor of the Ewing's family treated with standard induction chemotherapy comprising vincristine, dactinomycin, ifosfamide and etoposide (VIDE) followed by consolidation chemotherapy comprising vincristine, dactinomycin, and ifosfamide versus high-dose busulfan and melphalan (Bu-Mel) followed by autologous peripheral blood stem cell (PBSC) transplantation with or without radiotherapy and/or surgery.

Secondary

  • Determine the prognostic significance of EWS-Flil transcript in these patients.
  • Determine the frequency and prognostic value of minimal disease in bone marrow and PBSC, as determined by the presence or absence of EWS-Flil transcript, in these patients.
  • Determine the feasibility and toxicity of VIDE induction chemotherapy in these patients.
  • Determine the response of these patients to VIDE induction chemotherapy.
  • Determine the feasibility and toxicity of VAI consolodation chemotherapy in these patients.
  • Determine the feasibility and toxicity of Bu-Mel consolodation chemotherapy in these patients.
  • Determine event-free survival and overall survival of patients treated with these regimens by prognostic group analysis.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age and local treatment of the primary tumor (yes vs no).

Patients receive induction chemotherapy comprising vincristine IV on day 1 and ifosfamide IV over 3 hours, doxorubicin IV over 4 hours, and etoposide IV over 1 hour on days 1-3 (VIDE). Treatment repeats every 21 days for 4 courses in the absence of unacceptable toxicity. Peripheral blood stem cells (PBSC) are collected after course 3 and/or 4. Patients are evaluated after course 4. Patients in need of early radiotherapy due to an axial tumor or patients who require radiotherapy to the brain and/or spinal cord (at any time during study) are assigned to group 1. Patients not needing early radiotherapy are assigned to group 2.

  • Group 1: Patients receive 2 additional courses of VIDE induction chemotherapy (courses 5 and 6). Patients requiring radiotherapy to the axial tumor also undergo concurrent radiotherapy 5 days a week. Some patients may then undergo surgical resection of the tumor. All patients will then receive vincristine IV on day 1 and dactinomycin IV and ifosfamide IV over 3 hours on days 1 and 2 (VAI). Treatment repeats every 21 days for 8 courses (courses 7-14). Patients requiring radiotherapy to the brain and/or spinal cord also undergo concurrent radiotherapy.

  • Group 2: Patients undergo 2 additional courses of VIDE induction chemotherapy (courses 5 and 6). Some patients may then undergo surgical resection of the tumor. All patients receive VAI chemotherapy as in group 1 for 1 course. Patients are randomized to 1 of 2 consolidation therapy arms.

    • Arm I: Patients receive 7 additional courses of VAI chemotherapy (courses 8-14). Patients with unresectable, partially resected, or inadequately resected disease undergo concurrent whole-lung radiotherapy for 6-12 days.
    • Arm II: Patients receive high-dose chemotherapy comprising oral busulfan every 6 hours on days -6 to -3 and melphalan IV over 30 minutes on day -2. Patients receive autologous PBSC IV on day 0. Patients with unresectable, partially resected, or inadequately resected disease undergo concurrent radiotherapy 5 days a week for at least 5 weeks.

Patients are followed every 3 months for 4 years, every 6 months for 1 year, and then periodically thereafter.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: Approximately 1,200 patients will be accrued for this study within approximately 7 years.

Study Type

Interventional

Enrollment (Anticipated)

1200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Recruiting
        • Children's Hospital at Westmead
        • Contact:
          • Geoffrey B. McCowage
          • Phone Number: 61298452122
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Recruiting
        • Royal Children's Hospital
        • Contact:
          • Helen Irving
          • Phone Number: 617-3636-8671
    • South Australia
      • North Adelaide, South Australia, Australia, 5006
        • Recruiting
        • Women's and Children's Hospital
        • Contact:
          • Maria L. Kirby
          • Phone Number: 61881617411
    • Western Australia
      • Perth, Western Australia, Australia, 6001
        • Recruiting
        • Princess Margaret Hospital for Children
        • Contact:
          • Catherine H. Cole
          • Phone Number: 011-6189340-8238
  • Canada
      • Quebec, Canada, G1V 4G2
        • Recruiting
        • Centre Hospitalier Universitaire de Quebec
        • Contact:
          • Bruno Michon
          • Phone Number: 418-656-4141X47191
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Recruiting
        • University of Alberta Hospital
        • Contact:
          • Sunil Jayantilal' S. Desai
          • Phone Number: 780-248-5530
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • Recruiting
        • Children's and Women's Hospital of British Columbia
        • Contact:
          • Caron Strahlendorf
          • Phone Number: 604-875-3576
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • Recruiting
        • CancerCare Manitoba
        • Contact:
          • Rochelle A. Yanofsky
          • Phone Number: 204-787-4163
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Recruiting
        • Janeway Children's Health and Rehabilitation Centre
        • Contact:
          • Lisa Anne B. Goodyear
          • Phone Number: 709-777-4303
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3J 3G9
        • Recruiting
        • IWK Health Centre
        • Contact:
          • Margaret C. Yhap
          • Phone Number: 902-470-8778
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Recruiting
        • Hospital for Sick Children
        • Contact:
          • Sylvain Baruchel
          • Phone Number: 416-813-7795
    • Quebec
      • Montreal, Quebec, Canada, H3T 1C5
        • Recruiting
        • Hopital Sainte Justine
        • Contact:
          • Yvan Samson
          • Phone Number: 514-345-4931x2790
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Recruiting
        • Saskatoon Cancer Centre at the University of Saskatchewan
        • Contact:
          • Christopher Mpofu
          • Phone Number: 306-655-2744
  • New Zealand
      • Auckland, New Zealand, 1
        • Recruiting
        • Starship Children's Health
        • Contact:
          • Lochie R. Teague
          • Phone Number: 649-307-4949x22423
  • Puerto Rico
      • Santurce, Puerto Rico, 00912
        • Recruiting
        • San Jorge Children's Hospital
        • Contact:
          • Luis A. Clavell
          • Phone Number: 787-728-1575
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • Uab Comprehensive Cancer Center
    • Arizona
      • Phoenix, Arizona, United States, 85016-7710
        • Recruiting
        • Phoenix Children's Hospital
        • Contact:
          • Jessica Boklan
          • Phone Number: 602-546-0920
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
        • Contact:
          • Clinical Trial Office - Arkansas Cancer Research Center at Uni
          • Phone Number: 501-686-8274
    • California
      • Duarte, California, United States, 91010-3000
        • Recruiting
        • City of Hope Comprehensive Cancer Center
        • Contact:
          • Clinical Trials Office - City of Hope Comprehensive Cancer Cen
          • Phone Number: 800-826-4673
          • Email: becomingapatient@coh.org
      • Los Angeles, California, United States, 90027
        • Recruiting
        • Southern California Permanente Medical Group
        • Contact:
          • Robert M. Cooper
          • Phone Number: 323-783-5307
      • Los Angeles, California, United States, 90027
        • Recruiting
        • Childrens Hospital Los Angeles
        • Contact:
          • Leo Mascarenhas
          • Phone Number: 323-361-2529
      • Palo Alto, California, United States, 95798
        • Recruiting
        • Lucile Packard Children's Hospital at Stanford University Medical Center
        • Contact:
          • Neyssa M. Marina
          • Phone Number: 650-723-5535
      • Sacramento, California, United States, 95661
        • Recruiting
        • Kaiser Permanente Medical Center - Oakland
        • Contact:
          • Vincent A. Kiley
          • Phone Number: 916-474-2326
      • San Diego, California, United States, 92123-4282
        • Recruiting
        • Rady Children's Hospital - San Diego
        • Contact:
          • Clinical Trials Office - Rady Children's Hospital - San Diego
          • Phone Number: 858-966-5934
      • San Francisco, California, United States, 94115
        • Recruiting
        • UCSF Helen Diller Family Comprehensive Cancer Center
        • Contact:
          • Clinical Trials Office - UCSF Helen Diller Family Comprehensi
          • Phone Number: 877-827-3222
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Children's Hospital Colorado Center for Cancer and Blood Disorders
        • Contact:
          • Kelly W. Maloney
          • Phone Number: 720-777-6673
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • Recruiting
        • Alfred I. DuPont Hospital for Children
        • Contact:
          • Clinical Trials Office - Alfred I. duPont Hospital for Childre
          • Phone Number: 302-651-5755
    • District of Columbia
      • Washington, District of Columbia, United States, 20010-2970
        • Recruiting
        • Children's National Medical Center
        • Contact:
          • Clinical Trials Office - Children's National Medical Center
          • Phone Number: 202-884-2549
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Nemours Children's Clinic
        • Contact:
          • Eric S. Sandler
          • Phone Number: 904-697-3793
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Sylvester Comprehensive Cancer Center - Miami
        • Contact:
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Nemours Children's Clinic - Orlando
        • Contact:
          • Ramamoorthy Nagasubramanian
          • Phone Number: 407-650-7230
      • Pensacola, Florida, United States, 32504
        • Recruiting
        • Nemours Children's Clinic - Pensacola
        • Contact:
          • Jeffrey H. Schwartz
          • Phone Number: 850-505-4790
      • Saint Petersburg, Florida, United States, 33701
        • Recruiting
        • All Children's Hospital
        • Contact:
          • Gregory A. Hale
          • Phone Number: 727-767-4176
      • Tampa, Florida, United States, 33607
        • Recruiting
        • St. Joseph's Cancer Institute at St. Joseph's Hospital
        • Contact:
          • Clinical Trials Office - St. Joseph's Cancer Institute
          • Phone Number: 800-882-4123
      • West Palm Beach, Florida, United States, 33407
        • Recruiting
        • Kaplan Cancer Center at St. Mary's Medical Center
        • Contact:
          • Narayana Gowda
          • Phone Number: 561-844-6363
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
        • Contact:
          • Todd M. Cooper
          • Phone Number: 404-785-1838
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Recruiting
        • Cancer Research Center of Hawaii
        • Contact:
          • Clinical Trials Office - Cancer Research Center of Hawaii
          • Phone Number: 808-586-2979
    • Idaho
      • Boise, Idaho, United States, 83712-6297
        • Recruiting
        • Mountain States Tumor Institute at St. Luke's Regional Medical Center
        • Contact:
          • Eugenia Chang
          • Phone Number: 208-381-2731
    • Illinois
      • Chicago, Illinois, United States, 60637-1470
        • Recruiting
        • University of Chicago Cancer Research Center
        • Contact:
          • Clinical Trials Office - University of Chicago Cancer Research
          • Phone Number: 773-834-7424
      • Peoria, Illinois, United States, 61603
        • Recruiting
        • Saint Jude Midwest Affiliate
        • Contact:
          • Pedro A. De Alarcon
          • Phone Number: 309-655-4242
      • Springfield, Illinois, United States, 62794-9677
        • Recruiting
        • Simmons Cooper Cancer Institute
        • Contact:
          • Clinical Trials Office - Simmons Cooper Cancer Institute
          • Phone Number: 217-545-7929
    • Iowa
      • Iowa City, Iowa, United States, 52242-1002
        • Recruiting
        • Holden Comprehensive Cancer Center at University of Iowa
        • Contact:
          • Cancer Information Service
          • Phone Number: 800-237-1225
    • Kentucky
      • Louisville, Kentucky, United States, 40232
    • Louisiana
      • New Orleans, Louisiana, United States, 70118
        • Recruiting
        • Children's Hospital of New Orleans
        • Contact:
          • Clinical Trials Office - Children's Hospital of New Orleans
          • Phone Number: 504-894-5377
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Recruiting
        • Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
        • Contact:
          • Joseph M. Wiley
          • Phone Number: 410-601-6266
    • Massachusetts
      • Boston, Massachusetts, United States, 2115
        • Recruiting
        • Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
        • Contact:
          • Carlos Rodriguez-Galindo
          • Phone Number: 617-632-4580
    • Michigan
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Hurley Medical Center
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Helen DeVos Children's Hospital at Spectrum Health
        • Contact:
          • Clinical Trials Office - Helen DeVos Children's Hospital
          • Phone Number: 616-391-3050
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Recruiting
        • Van Elslander Cancer Center at St. John Hospital and Medical Center
      • Kalamazoo, Michigan, United States, 49007-5381
        • Recruiting
        • Bronson Methodist Hospital
        • Contact:
          • Jeffrey S. Lobel
          • Phone Number: 269-341-6350
      • Lansing, Michigan, United States, 48910
        • Recruiting
        • Breslin Cancer Center at Ingham Regional Medical Center
        • Contact:
          • Clinical Trials Office - Breslin Cancer Center at Ingham Regio
          • Phone Number: 517-334-2765
    • Minnesota
      • Duluth, Minnesota, United States, 55805-1983
        • Recruiting
        • CCOP - Duluth
        • Contact:
          • Contact Person
          • Phone Number: 218-786-8364
      • Minneapolis, Minnesota, United States, 55404
        • Recruiting
        • Children's Hospitals and Clinics of Minnesota - Minneapolis
        • Contact:
          • Clinical Trials Office - Children's Hospitals and Clinics of M
          • Phone Number: 612-813-5193
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • Masonic Cancer Center at University of Minnesota
        • Contact:
          • Clinical Trials Office - Masonic Cancer Center at University o
          • Phone Number: 612-624-2620
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic Cancer Center
      • St. Paul, Minnesota, United States, 55102-2392
        • Recruiting
        • Children's Hospitals and Clinics of Minnesota - St. Paul
        • Contact:
          • Contact Person
          • Phone Number: 612-220-6000
    • Mississippi
      • Jackson, Mississippi, United States, 39216-4505
        • Recruiting
        • University of Mississippi Cancer Clinic
        • Contact:
          • Gail C. Megason
          • Phone Number: 601-984-5220
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Recruiting
        • Children's Mercy Hospital
        • Contact:
          • Maxine L. Hetherington
          • Phone Number: 816-234-3265
      • St. Louis, Missouri, United States, 63110
        • Recruiting
        • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
        • Contact:
          • Robert J. Hayashi
          • Phone Number: 314-454-2041
    • Nevada
      • Las Vegas, Nevada, United States, 89109-2306
        • Recruiting
        • CCOP - Nevada Cancer Research Foundation
        • Contact:
          • Jonathan Bernstein
          • Phone Number: 702-732-1493
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Hackensack University Medical Center Cancer Center
        • Contact:
          • Clinical Trials Office - Hackensack University Medical Center
          • Phone Number: 201-996-2879
    • New York
      • Bronx, New York, United States, 10461
        • Recruiting
        • Albert Einstein Cancer Center at Albert Einstein College of Medicine
      • Buffalo, New York, United States, 14263-0001
        • Recruiting
        • Roswell Park Cancer Institute
        • Contact:
          • Clinical Trials Office - Roswell Park Cancer Institute
          • Phone Number: 877-275-7724
      • New York, New York, United States, 10032
        • Recruiting
        • Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
        • Contact:
          • Clinical Trials Office - Herbert Irving Comprehensive Cancer C
          • Phone Number: 212-305-8615
      • Rochester, New York, United States, 14642
        • Recruiting
        • James P. Wilmot Cancer Center at University of Rochester Medical Center
        • Contact:
          • Lisa R. Hackney
          • Phone Number: 585-275-2981
      • Syracuse, New York, United States, 13210
        • Recruiting
        • SUNY Upstate Medical University Hospital
        • Contact:
          • Clinical Trials Office - SUNY Upstate Medical University Hospi
          • Phone Number: 315-464-5476
    • North Carolina
      • Charlotte, North Carolina, United States, 28232-2861
        • Recruiting
        • Blumenthal Cancer Center at Carolinas Medical Center
        • Contact:
          • Clinical Trials Office - Blumenthal Cancer Center at Carolinas
          • Phone Number: 704-355-2884
      • Charlotte, North Carolina, United States, 28233-3549
        • Recruiting
        • Presbyterian Cancer Center at Presbyterian Hospital
        • Contact:
          • Clinical Trials Office - Presbyterian Cancer Center at Presbyt
          • Phone Number: 704-384-5369
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke Cancer Institute
        • Contact:
          • Clinical Trials Office - Duke Cancer Institute
          • Phone Number: 888-275-3853
      • Greenville, North Carolina, United States, 27834
        • Recruiting
        • Leo W. Jenkins Cancer Center at ECU Medical School
        • Contact:
          • Clinical Trials Office - Leo W. Jenkins Cancer Center at ECU M
          • Phone Number: 252-744-2391
    • Ohio
      • Cincinnati, Ohio, United States, 45229-3039
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
        • Contact:
          • Clinical Trials Office - Cincinnati Children's Hospital Medica
          • Phone Number: 513-636-2799
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Taussig Cancer Center
        • Contact:
          • Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente
          • Phone Number: 866-223-8100
      • Cleveland, Ohio, United States, 44106-5000
        • Recruiting
        • Rainbow Babies and Children's Hospital
        • Contact:
          • Yousif (Joe) H. Matloub
          • Phone Number: 216-844-3345
      • Columbus, Ohio, United States, 43205-2696
        • Recruiting
        • Nationwide Children's Hospital
        • Contact:
          • Laura T. Martin
          • Phone Number: 614-722-3582
      • Dayton, Ohio, United States, 45404-1815
        • Recruiting
        • Dayton Children's - Dayton
        • Contact:
          • Emmett H. Broxson
          • Phone Number: 937-641-3111
      • Toledo, Ohio, United States, 43606
        • Recruiting
        • Toledo Hospital
      • Youngstown, Ohio, United States, 44501
        • Recruiting
        • Tod Children's Hospital
        • Contact:
          • Clinical Trials Office - Tod Children's Hospital
          • Phone Number: 330-884-3955
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • Oklahoma University Cancer Institute
        • Contact:
          • Rene Y. McNall-Knapp
          • Phone Number: 405-271-5311
    • Oregon
      • Portland, Oregon, United States, 97227
        • Recruiting
        • Legacy Emanuel Children's Hospital
        • Contact:
          • Clinical Trials Office - Legacy Emanuel Children's Hospital
          • Phone Number: 503-413-2560
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18017
        • Recruiting
        • Lehigh Valley Hospital - Muhlenberg
        • Contact:
          • Philip M. Monteleone
          • Phone Number: 484-884-3333
      • Hershey, Pennsylvania, United States, 17033-0850
        • Recruiting
        • Penn State Children's Hospital
        • Contact:
          • John F. Kuttesch
          • Phone Number: 717-531-6012
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Children's Hospital of Philadelphia
        • Contact:
          • Elizabeth Fox
          • Phone Number: 267-425-3010
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • Children's Hospital of Pittsburgh of UPMC
        • Contact:
          • Clinical Trials Office - Children's Hospital of Pittsburgh
          • Phone Number: 412-692-7056
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Recruiting
        • Greenville Hospital Cancer Center
        • Contact:
          • Clinical Trials Office - Greenville Hospital Cancer Center
          • Phone Number: 864-241-6251
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • Avera Cancer Institute
        • Contact:
          • Contact Person
          • Phone Number: 605-322-3000
    • Tennessee
      • Knoxville, Tennessee, United States, 37916
        • Recruiting
        • East Tennessee Children's Hospital
        • Contact:
          • Ray C. Pais
          • Phone Number: 865-541-8266
    • Texas
      • Amarillo, Texas, United States, 79106
        • Recruiting
        • Texas Tech University Health Sciences Center School of Medicine - Amarillo
        • Contact:
          • Osvaldo Regueira
          • Phone Number: 806-354-5434x282
      • Corpus Christi, Texas, United States, 78411
        • Recruiting
        • Driscoll Children's Hospital
        • Contact:
          • Clinical Trials Office - Driscoll Children's Hospital
          • Phone Number: 361-694-5311
      • Dallas, Texas, United States, 75390
        • Recruiting
        • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • Cook Children's Medical Center - Fort Worth
        • Contact:
          • Clinical Trials Office - Cook's Children's Medical Center
          • Phone Number: 682-885-2103
      • San Antonio, Texas, United States, 78207
        • Recruiting
        • University of Texas Health Science Center at San Antonio
        • Contact:
          • Anne-Marie R. Langevin
          • Phone Number: 210-567-7477
      • San Antonio, Texas, United States, 78229-3993
        • Recruiting
        • Methodist Children's Hospital of South Texas
        • Contact:
          • Jaime Estrada
          • Phone Number: 210-575-7268
    • Utah
      • Salt Lake City, Utah, United States, 84113-1100
        • Recruiting
        • Primary Children's Medical Center
        • Contact:
          • Phillip E. Barnette
          • Phone Number: 801-662-4700
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia Cancer Center
        • Contact:
          • Kimberly P. Dunsmore
          • Phone Number: 434-924-5105
      • Falls Church, Virginia, United States, 22042-3300
        • Recruiting
        • Inova Fairfax Hospital
        • Contact:
          • Clinical Trials Office - Inova Fairfax Hospital
          • Phone Number: 703-208-6650
      • Norfolk, Virginia, United States, 23507-1971
        • Recruiting
        • Children's Hospital of The King's Daughters
        • Contact:
          • Eric J. Lowe
          • Phone Number: 757-668-7243
    • Washington
      • Seattle, Washington, United States, 98105
        • Recruiting
        • Children's Hospital and Regional Medical Center - Seattle
        • Contact:
          • Julie R. Park
          • Phone Number: 206-987-2106
      • Spokane, Washington, United States, 99220-2555
        • Recruiting
        • Providence Cancer Center at Sacred Heart Medical Center
        • Contact:
          • Judy L. Felgenhauer
          • Phone Number: 509-474-2777
      • Tacoma, Washington, United States, 98405
        • Recruiting
        • Mary Bridge Children's Hospital and Health Center - Tacoma
        • Contact:
          • Robert G. Irwin
          • Phone Number: 253-403-3481
    • West Virginia
      • Charleston, West Virginia, United States, 25302
        • Recruiting
        • West Virginia University Health Sciences Center - Charleston
        • Contact:
          • Allen R. Chauvenet
          • Phone Number: 304-388-1552
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54307-3508
        • Recruiting
        • St. Vincent Hospital Regional Cancer Center
      • Marshfield, Wisconsin, United States, 54449
        • Recruiting
        • Marshfield Clinic - Marshfield Center
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Midwest Children's Cancer Center at Children's Hospital of Wisconsin
        • Contact:
          • Michael E. Kelly
          • Phone Number: 414-456-4170

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 49 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed tumor of the Ewing's family of bone or soft tissue

    • Ewing's sarcoma
    • Peripheral primitive neuroectodermal tumor

  • Disease meeting one of the following criteria:

    • Resectable localized disease (tumor volume less than 200 mL)
    • Localized disease previously resected at diagnosis
    • Unresectable disease (at least 200 mL tumor volume) but radiotherapy as local control can be delayed
    • Localized disease with early radiotherapy required
    • Pulmonary and/or pleural metastases only
    • Extrapulmonary/pleural metastases (skeleton, bone marrow, lymph nodes)
  • No more than 45 days since definitive biopsy

PATIENT CHARACTERISTICS:

Age:

  • Under 50

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Renal function normal
  • Glomerular filtration rate at least 60 mL/min

Cardiovascular:

  • Normal cardiac function
  • Fractional shortening at least 29%
  • Ejection fraction at least 40%

Other:

  • No medical, psychiatric, or social condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • See Disease Characteristics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Patients receive 2 additional courses of VIDE induction chemotherapy (courses 5 and 6). Patients requiring radiotherapy to the axial tumor also undergo concurrent radiotherapy 5 days a week. Some patients may then undergo surgical resection of the tumor. All patients will then receive vincristine IV on day 1 and dactinomycin IV and ifosfamide IV over 3 hours on days 1 and 2 (VAI). Treatment repeats every 21 days for 8 courses (courses 7-14). Patients requiring radiotherapy to the brain and/or spinal cord also undergo concurrent radiotherapy.
Drug: etoposide
Given IV
Drug: doxorubicin hydrochloride
Given IV
Drug: vincristine sulfate
Given IV
Drug: ifosfamide
Given IV
Biological: dactinomycin
Given IV
Procedure: conventional surgery
Given to patients deemed to require it
Radiation: radiation therapy
Given to patients deemed to require it
Experimental: Group 2, arm I
Patients undergo 2 additional courses of VIDE induction chemotherapy (courses 5 and 6). Some patients may then undergo surgical resection of the tumor. All patients receive VAI chemotherapy as in group 1 for 1 course. Patients then receive 7 additional courses of VAI chemotherapy (courses 8-14). Patients with unresectable, partially resected, or inadequately resected disease undergo concurrent whole-lung radiotherapy for 6-12 days.
Drug: etoposide
Given IV
Drug: doxorubicin hydrochloride
Given IV
Drug: vincristine sulfate
Given IV
Drug: ifosfamide
Given IV
Biological: dactinomycin
Given IV
Procedure: conventional surgery
Given to patients deemed to require it
Radiation: radiation therapy
Given to patients deemed to require it
Experimental: Group 2, arm II
Patients undergo 2 additional courses of VIDE induction chemotherapy (courses 5 and 6). Some patients may then undergo surgical resection of the tumor. All patients receive VAI chemotherapy as in group 1 for 1 course. Patients then receive high-dose chemotherapy comprising oral busulfan every 6 hours on days -6 to -3 and melphalan IV over 30 minutes on day -2. Patients receive autologous PBSC IV on day 0. Patients with unresectable, partially resected, or inadequately resected disease undergo concurrent radiotherapy 5 days a week for at least 5 weeks.
Drug: etoposide
Given IV
Drug: doxorubicin hydrochloride
Given IV
Drug: vincristine sulfate
Given IV
Drug: ifosfamide
Given IV
Biological: dactinomycin
Given IV
Procedure: conventional surgery
Given to patients deemed to require it
Radiation: radiation therapy
Given to patients deemed to require it
Drug: busulfan
Given orally and IV
Drug: melphalan
Given orally and IV
Procedure: autologous hematopoietic stem cell transplantation
Given IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall survival
Event-free survival

Secondary Outcome Measures

Outcome Measure
Feasibility, toxicity, and response at 1 month following induction therapy
Feasibility and toxicity of consolidation regimens at 1 month following consolidation therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leicester

Collaborators

National Cancer Institute (NCI)
Children's Cancer and Leukaemia Group
European Organisation for Research and Treatment of Cancer - EORTC
Children's Oncology Group
Swiss Group for Clinical Cancer Research
Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany
Societe Francaise Oncologie Pediatrique
Gesellschaft fur Padiatrische Onkologie und Hamatologie - Austria
EBMT Solid Tumors Working Party

Investigators

  • Study Chair: Ian J. Lewis, MD, Leeds Cancer Centre at St. James's University Hospital
  • Study Chair: Douglas Hawkins, MD, Seattle Children's Hospital
  • Study Chair: Alan W. Craft, MD, Sir James Spence Institute of Child Health at Royal Victoria Infirmary
  • Study Chair: Odile Oberlin, MD, Gustave Roussy, Cancer Campus, Grand Paris
  • Ian R. Judson, MA, MD, FRCP, Institute of Cancer Research, United Kingdom
  • Study Chair: Helmut Gadner, MD, FRCPG, St. Anna Kinderkrebsforschung
  • Study Chair: G. Ulrich Exner, MD, Balgrist Universitaetsklinik

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2001

Primary Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

July 11, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

June 24, 2014

Last Update Submitted That Met QC Criteria

June 23, 2014

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068608
  • EURO-EWING-INTERGROUP-EE99
  • EBMT-INTERGROUP-EE99
  • EORTC-62981
  • GPOH-AUSTRIA-INTERGROUP-EE99
  • GPOH-GERMANY-INTERGROUP-EE99
  • SFOP-INTERGROUP-EE99
  • SWS-SAKK-INTERGROUP-EE99
  • CCLG-INTERGROUP-EE99
  • COG-AEWS0331
  • EU-20213

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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