Recruiting
Phase 3

Combination Chemotherapy

Sponsor:

University of Leicester

Code:

NCT00020566

Conditions

Sarcoma

Eligibility Criteria

Sex: All

Age: 0 - 49

Healthy Volunteers: Not accepted

Interventions

dactinomycin

busulfan

doxorubicin hydrochloride

etoposide

ifosfamide

Study Details

Brief summary:

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.

Conditions

Sarcoma

Study ID

NCT00020566

Start date

Feb, 2001

Status verified date

Jun, 2012

Primary completion date

Dec, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 49

Healthy Volunteers: Not accepted

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 Design

Enrollment

1200 participants

Anticipated

Allocation

Randomized

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

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.

Interventions

dactinomycin

Given IV

busulfan

Given orally and IV

doxorubicin hydrochloride

Given IV

etoposide

Given IV

ifosfamide

Given IV

melphalan

Given orally and IV

vincristine sulfate

Given IV

autologous hematopoietic stem cell transplantation

Given IV

conventional surgery

Given to patients deemed to require it

radiation therapy

Given to patients deemed to require it

Primary outcome measure

  • Event-free survival [ Time Frame: undefined ]
  • Overall survival [ Time Frame: undefined ]

Central Contacts and Locations

Locations

UAB Comprehensive Cancer Center

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Clinical Trials Office - UAB Comprehensive Cancer Center

205-934-0309

Phoenix Children's Hospital

Recruiting

Phoenix, Arizona, United States, 85016-7710

Contacts

Jessica Boklan

602-546-0920

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Clinical Trial Office - Arkansas Cancer Research Center at Uni

501-686-8274

City of Hope Comprehensive Cancer Center

Recruiting

Duarte, California, United States, 91010-3000

Contacts

Clinical Trials Office - City of Hope Comprehensive Cancer Cen

800-826-4673becomingapatient@coh.org

Childrens Hospital Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Contacts

Leo Mascarenhas

323-361-2529

Southern California Permanente Medical Group

Recruiting

Los Angeles, California, United States, 90027

Contacts

Robert M. Cooper

323-783-5307

Lucile Packard Children's Hospital at Stanford University Medical Center

Recruiting

Palo Alto, California, United States, 95798

Contacts

Neyssa M. Marina

650-723-5535

Kaiser Permanente Medical Center - Oakland

Recruiting

Sacramento, California, United States, 95661

Contacts

Vincent A. Kiley

916-474-2326

Rady Children's Hospital - San Diego

Recruiting

San Diego, California, United States, 92123-4282

Contacts

Clinical Trials Office - Rady Children's Hospital - San Diego

858-966-5934

UCSF Helen Diller Family Comprehensive Cancer Center

Recruiting

San Francisco, California, United States, 94115

Contacts

Clinical Trials Office - UCSF Helen Diller Family Comprehensi

877-827-3222

Children's Hospital Colorado Center for Cancer and Blood Disorders

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Kelly W. Maloney

720-777-6673

Alfred I. duPont Hospital for Children

Recruiting

Wilmington, Delaware, United States, 19803

Contacts

Clinical Trials Office - Alfred I. duPont Hospital for Childre

302-651-5755

Children's National Medical Center

Recruiting

Washington, District of Columbia, United States, 20010-2970

Contacts

Clinical Trials Office - Children's National Medical Center

202-884-2549

Nemours Children's Clinic

Recruiting

Jacksonville, Florida, United States, 32207

Contacts

Eric S. Sandler

904-697-3793

University of Miami Sylvester Comprehensive Cancer Center - Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

University of Miami Sylvester Comprehensive Cancer Center Clin

866-574-5124Sylvester@emergingmed.com

Nemours Children's Clinic - Orlando

Recruiting

Orlando, Florida, United States, 32806

Contacts

Ramamoorthy Nagasubramanian

407-650-7230

Nemours Children's Clinic - Pensacola

Recruiting

Pensacola, Florida, United States, 32504

Contacts

Jeffrey H. Schwartz

850-505-4790

All Children's Hospital

Recruiting

Saint Petersburg, Florida, United States, 33701

Contacts

Gregory A. Hale

727-767-4176

St. Joseph's Cancer Institute at St. Joseph's Hospital

Recruiting

Tampa, Florida, United States, 33607

Contacts

Clinical Trials Office - St. Joseph's Cancer Institute

800-882-4123

Kaplan Cancer Center at St. Mary's Medical Center

Recruiting

West Palm Beach, Florida, United States, 33407

Contacts

Narayana Gowda

561-844-6363

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

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Todd M. Cooper

404-785-1838

Cancer Research Center of Hawaii

Recruiting

Honolulu, Hawaii, United States, 96813

Contacts

Clinical Trials Office - Cancer Research Center of Hawaii

808-586-2979

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

Recruiting

Boise, Idaho, United States, 83712-6297

Contacts

Eugenia Chang

208-381-2731

University of Chicago Cancer Research Center

Recruiting

Chicago, Illinois, United States, 60637-1470

Contacts

Clinical Trials Office - University of Chicago Cancer Research

773-834-7424

Saint Jude Midwest Affiliate

Recruiting

Peoria, Illinois, United States, 61603

Contacts

Pedro A. De Alarcon

309-655-4242

Simmons Cooper Cancer Institute

Recruiting

Springfield, Illinois, United States, 62794-9677

Contacts

Clinical Trials Office - Simmons Cooper Cancer Institute

217-545-7929

Holden Comprehensive Cancer Center at University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242-1002

Contacts

Cancer Information Service

800-237-1225

Kosair Children's Hospital

Recruiting

Louisville, Kentucky, United States, 40232

Contacts

Clinical Trials Office - Kosair Children's Hospital

502-629-5500CancerResource@nortonhealthcare.org

Children's Hospital of New Orleans

Recruiting

New Orleans, Louisiana, United States, 70118

Contacts

Clinical Trials Office - Children's Hospital of New Orleans

504-894-5377

Alvin and Lois Lapidus Cancer Institute at Sinai Hospital

Recruiting

Baltimore, Maryland, United States, 21215

Contacts

Joseph M. Wiley

410-601-6266

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

Recruiting

Boston, Massachusetts, United States, 2115

Contacts

Carlos Rodriguez-Galindo

617-632-4580

Hurley Medical Center

Recruiting

Flint, Michigan, United States, 48503

Contacts

Clinical Trials Office - Hurley Medical Center

810-762-8057

Helen DeVos Children's Hospital at Spectrum Health

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Clinical Trials Office - Helen DeVos Children's Hospital

616-391-3050

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

Recruiting

Grosse Pointe Woods, Michigan, United States, 48236

Contacts

Clincial Trials Office - Van Elslander Cancer Center at St. Jo

313-343-3166

Bronson Methodist Hospital

Recruiting

Kalamazoo, Michigan, United States, 49007-5381

Contacts

Jeffrey S. Lobel

269-341-6350

Breslin Cancer Center at Ingham Regional Medical Center

Recruiting

Lansing, Michigan, United States, 48910

Contacts

Clinical Trials Office - Breslin Cancer Center at Ingham Regio

517-334-2765

CCOP - Duluth

Recruiting

Duluth, Minnesota, United States, 55805-1983

Contacts

Contact Person

218-786-8364

Children's Hospitals and Clinics of Minnesota - Minneapolis

Recruiting

Minneapolis, Minnesota, United States, 55404

Contacts

Clinical Trials Office - Children's Hospitals and Clinics of M

612-813-5193

Masonic Cancer Center at University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Clinical Trials Office - Masonic Cancer Center at University o

612-624-2620

Mayo Clinic Cancer Center

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Office - All Mayo Clinic Locations

507-538-7623

Children's Hospitals and Clinics of Minnesota - St. Paul

Recruiting

St. Paul, Minnesota, United States, 55102-2392

Contacts

Contact Person

612-220-6000

University of Mississippi Cancer Clinic

Recruiting

Jackson, Mississippi, United States, 39216-4505

Contacts

Gail C. Megason

601-984-5220

Children's Mercy Hospital

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Maxine L. Hetherington

816-234-3265

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

Recruiting

St. Louis, Missouri, United States, 63110

Contacts

Robert J. Hayashi

314-454-2041

CCOP - Nevada Cancer Research Foundation

Recruiting

Las Vegas, Nevada, United States, 89109-2306

Contacts

Jonathan Bernstein

702-732-1493

Hackensack University Medical Center Cancer Center

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Clinical Trials Office - Hackensack University Medical Center

201-996-2879

Albert Einstein Cancer Center at Albert Einstein College of Medicine

Recruiting

Bronx, New York, United States, 10461

Contacts

Clinical Trials Office - Albert Einstein Cancer Center at Albe

718-904-2730aecc@aecom.yu.edu

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263-0001

Contacts

Clinical Trials Office - Roswell Park Cancer Institute

877-275-7724

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Clinical Trials Office - Herbert Irving Comprehensive Cancer C

212-305-8615

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

Recruiting

Rochester, New York, United States, 14642

Contacts

Lisa R. Hackney

585-275-2981

SUNY Upstate Medical University Hospital

Recruiting

Syracuse, New York, United States, 13210

Contacts

Clinical Trials Office - SUNY Upstate Medical University Hospi

315-464-5476

Blumenthal Cancer Center at Carolinas Medical Center

Recruiting

Charlotte, North Carolina, United States, 28232-2861

Contacts

Clinical Trials Office - Blumenthal Cancer Center at Carolinas

704-355-2884

Presbyterian Cancer Center at Presbyterian Hospital

Recruiting

Charlotte, North Carolina, United States, 28233-3549

Contacts

Clinical Trials Office - Presbyterian Cancer Center at Presbyt

704-384-5369

Duke Cancer Institute

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Clinical Trials Office - Duke Cancer Institute

888-275-3853

Leo W. Jenkins Cancer Center at ECU Medical School

Recruiting

Greenville, North Carolina, United States, 27834

Contacts

Clinical Trials Office - Leo W. Jenkins Cancer Center at ECU M

252-744-2391

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229-3039

Contacts

Clinical Trials Office - Cincinnati Children's Hospital Medica

513-636-2799

Rainbow Babies and Children's Hospital

Recruiting

Cleveland, Ohio, United States, 44106-5000

Contacts

Yousif (Joe) H. Matloub

216-844-3345

Cleveland Clinic Taussig Cancer Center

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente

866-223-8100

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205-2696

Contacts

Laura T. Martin

614-722-3582

Dayton Children's - Dayton

Recruiting

Dayton, Ohio, United States, 45404-1815

Contacts

Emmett H. Broxson

937-641-3111

Toledo Hospital

Recruiting

Toledo, Ohio, United States, 43606

Contacts

Clinical Trials Office - Toledo Hospital

419-824-1842

Tod Children's Hospital

Recruiting

Youngstown, Ohio, United States, 44501

Contacts

Clinical Trials Office - Tod Children's Hospital

330-884-3955

Oklahoma University Cancer Institute

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Rene Y. McNall-Knapp

405-271-5311

Legacy Emanuel Children's Hospital

Recruiting

Portland, Oregon, United States, 97227

Contacts

Clinical Trials Office - Legacy Emanuel Children's Hospital

503-413-2560

Lehigh Valley Hospital - Muhlenberg

Recruiting

Bethlehem, Pennsylvania, United States, 18017

Contacts

Philip M. Monteleone

484-884-3333

Penn State Children's Hospital

Recruiting

Hershey, Pennsylvania, United States, 17033-0850

Contacts

John F. Kuttesch

717-531-6012

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Elizabeth Fox

267-425-3010

Children's Hospital of Pittsburgh of UPMC

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Clinical Trials Office - Children's Hospital of Pittsburgh

412-692-7056

Greenville Hospital Cancer Center

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Clinical Trials Office - Greenville Hospital Cancer Center

864-241-6251

Avera Cancer Institute

Recruiting

Sioux Falls, South Dakota, United States, 57105

Contacts

Contact Person

605-322-3000

East Tennessee Children's Hospital

Recruiting

Knoxville, Tennessee, United States, 37916

Contacts

Ray C. Pais

865-541-8266

Texas Tech University Health Sciences Center School of Medicine - Amarillo

Recruiting

Amarillo, Texas, United States, 79106

Contacts

Osvaldo Regueira

806-354-5434x282

Driscoll Children's Hospital

Recruiting

Corpus Christi, Texas, United States, 78411

Contacts

Clinical Trials Office - Driscoll Children's Hospital

361-694-5311

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

Recruiting

Dallas, Texas, United States, 75390

Contacts

Clinical Trials Office - Simmons Comprehensive Cancer Center a

866-460-4673; 214-648-7097

Cook Children's Medical Center - Fort Worth

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Clinical Trials Office - Cook's Children's Medical Center

682-885-2103

University of Texas Health Science Center at San Antonio

Recruiting

San Antonio, Texas, United States, 78207

Contacts

Anne-Marie R. Langevin

210-567-7477

Methodist Children's Hospital of South Texas

Recruiting

San Antonio, Texas, United States, 78229-3993

Contacts

Jaime Estrada

210-575-7268

Primary Children's Medical Center

Recruiting

Salt Lake City, Utah, United States, 84113-1100

Contacts

Phillip E. Barnette

801-662-4700

University of Virginia Cancer Center

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Kimberly P. Dunsmore

434-924-5105

Inova Fairfax Hospital

Recruiting

Falls Church, Virginia, United States, 22042-3300

Contacts

Clinical Trials Office - Inova Fairfax Hospital

703-208-6650

Children's Hospital of The King's Daughters

Recruiting

Norfolk, Virginia, United States, 23507-1971

Contacts

Eric J. Lowe

757-668-7243

Children's Hospital and Regional Medical Center - Seattle

Recruiting

Seattle, Washington, United States, 98105

Contacts

Julie R. Park

206-987-2106

Providence Cancer Center at Sacred Heart Medical Center

Recruiting

Spokane, Washington, United States, 99220-2555

Contacts

Judy L. Felgenhauer

509-474-2777

Mary Bridge Children's Hospital and Health Center - Tacoma

Recruiting

Tacoma, Washington, United States, 98405

Contacts

Robert G. Irwin

253-403-3481

West Virginia University Health Sciences Center - Charleston

Recruiting

Charleston, West Virginia, United States, 25302

Contacts

Allen R. Chauvenet

304-388-1552

St. Vincent Hospital Regional Cancer Center

Recruiting

Green Bay, Wisconsin, United States, 54307-3508

Contacts

Clinical Trials Office - St. Vincent Hospital Regional Cancer

920-433-8889

Marshfield Clinic - Marshfield Center

Recruiting

Marshfield, Wisconsin, United States, 54449

Contacts

Clinical Trials Office - Marshfield Clinic - Marshfield Center

800-782-1581 ext. 94457

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

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Michael E. Kelly

414-456-4170

University of Alberta Hospital

Recruiting

Edmonton, Alberta, Canada, T6G 2B7

Contacts

Sunil Jayantilal' S. Desai

780-248-5530

Children's and Women's Hospital of British Columbia

Recruiting

Vancouver, British Columbia, Canada, V6H 3V4

Contacts

Caron Strahlendorf

604-875-3576

CancerCare Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3E 0V9

Contacts

Rochelle A. Yanofsky

204-787-4163

Janeway Children's Health and Rehabilitation Centre

Recruiting

St. John's, Newfoundland and Labrador, Canada, A1B 3V6

Contacts

Lisa Anne B. Goodyear

709-777-4303

IWK Health Centre

Recruiting

Halifax, Nova Scotia, Canada, B3J 3G9

Contacts

Margaret C. Yhap

902-470-8778

Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5G 1X8

Contacts

Sylvain Baruchel

416-813-7795

Hopital Sainte Justine

Recruiting

Montreal, Quebec, Canada, H3T 1C5

Contacts

Yvan Samson

514-345-4931x2790

Saskatoon Cancer Centre at the University of Saskatchewan

Recruiting

Saskatoon, Saskatchewan, Canada, S7N 4H4

Contacts

Christopher Mpofu

306-655-2744

Centre Hospitalier Universitaire de Quebec

Recruiting

Quebec, Canada, G1V 4G2

Contacts

Bruno Michon

418-656-4141X47191

More Information

Sponsor

University of Leicester

Last update posted

Jun 24, 2014

Last verified

Jun, 2012

Keywords

  • localized Ewing sarcoma/peripheral primitive neuroectodermal tumor
  • metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Leicester on 2014-06-24.