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Comparison of Combination Chemotherapy Regimens in Treating Patients With Ewing's Sarcoma or Neuroectodermal Tumor

Primary Purpose

Sarcoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
filgrastim
cyclophosphamide
doxorubicin hydrochloride
etoposide
ifosfamide
vincristine sulfate
adjuvant therapy
conventional surgery
neoadjuvant therapy
brachytherapy
radiation therapy
Sponsored by
Children's Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring localized Ewing sarcoma/peripheral primitive neuroectodermal tumor

Eligibility Criteria

0 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed localized Ewing's sarcoma or peripheral primitive neuroectodermal tumor (PNET) of the bone or soft tissues Diagnostic biopsy of primary tumor within 30 days of study Paraspinal or bony skull tumors of extradural origin allowed No intradural soft tissue tumors Askin's tumor of the chest wall allowed Chest wall tumors with ipsilateral pleural effusions or ipsilateral pleural-based secondary tumor nodules allowed No contralateral pleural effusions No metastatic disease or distant node involvement One pulmonary or pleural nodule greater than 1 cm in diameter OR more than 1 nodule greater than 0.5 cm in diameter are considered pulmonary metastasis Solitary lung nodules of 0.5-1 cm OR multiple nodules of 0.3-0.5 cm allowed unless biopsy positive for tumor Light microscopic appearance (hematoxylin and eosin stained) consistent with Ewing's sarcoma or peripheral PNET No immunohistochemical or ultrastructural evidence of rhabdomyosarcoma No esthesioneuroblastoma Clinically or pathologically involved regional lymph nodes allowed No CNS involvement PATIENT CHARACTERISTICS: Age: 50 and under at diagnosis Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine normal for age Creatinine clearance or isotope glomerular filtration rate at least 75 mL/min Cardiovascular: Shortening fraction at least 28% by echocardiography OR Ejection fraction at least 55% by radionuclide angiogram Other: Not pregnant or nursing Fertile patients must use effective contraception No other prior malignancy except skin cancer diagnosed at least 5 years ago and currently in remission PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy for skin cancer No concurrent sargramostim (GM-CSF) No concurrent pegfilgrastim Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Prior complete or partial excision of primary tumor allowed

Sites / Locations

  • Comprehensive Cancer Center at University of Alabama at Birmingham
  • University of South Alabama Cancer Research Institute
  • Phoenix Children's Hospital
  • Arizona Cancer Center at University of Arizona Health Sciences Center
  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
  • Southern California Permanente Medical Group
  • City of Hope Comprehensive Cancer Center
  • Rebecca and John Moores UCSD Cancer Center
  • Loma Linda University Cancer Institute at Loma Linda University Medical Center
  • Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
  • Children's Hospital Los Angeles
  • Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
  • Jonsson Comprehensive Cancer Center at UCLA
  • Children's Hospital Central California
  • Children's Hospital and Research Center at Oakland
  • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
  • Children's Hospital of Orange County
  • Lucile Packard Children's Hospital at Stanford University Medical Center
  • Sutter Cancer Center
  • University of California Davis Cancer Center
  • Kaiser Permanente Medical Center - Sacramento
  • Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
  • Children's Hospital and Health Center - San Diego
  • UCSF Comprehensive Cancer Center
  • Santa Barbara Cottage Hospital
  • Kaiser Permanente Medical Center - Santa Clara
  • General Robert Huyser Cancer Center at David Grant Medical Center
  • Children's Hospital Cancer Center
  • Presbyterian - St. Luke's Medical Center
  • Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
  • Yale Comprehensive Cancer Center
  • Alfred I. duPont Hospital for Children
  • Lombardi Cancer Center at Georgetown University Medical Center
  • Children's National Medical Center
  • Broward General Medical Center
  • Children's Hospital of Southwest Florida
  • University of Florida Shands Cancer Center
  • Joe DiMaggio Children's Hospital at Memorial
  • Nemours Children's Clinic
  • Jackson Memorial Hospital
  • Miami Children's Hospital
  • Baptist-South Miami Regional Cancer Program
  • Florida Hospital Cancer Institute
  • Nemours Children's Clinic-Orlando
  • Sacred Heart Children's Hospital
  • All Children's Hospital
  • St. Joseph's Children's Hospital of Tampa
  • Kaplan Cancer Center at St. Mary's Medical Center
  • AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus
  • MBCCOP-Medical College of Georgia Cancer Center
  • Medical Center of Central Georgia
  • Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
  • Cancer Research Center of Hawaii
  • Tripler Army Medical Center
  • St. Luke's Mountain States Tumor Institute - Boise
  • University of Chicago Cancer Research Center
  • Rush University Medical Center
  • University of Illinois Medical Center
  • Children's Memorial Hospital - Chicago
  • Advocate Hope Children's Hospital
  • Lutheran General Cancer Care Center
  • Saint Jude Midwest Affiliate
  • Southern Illinois University School of Medicine
  • Riley Children Cancer Center at Riley Hospital for Children
  • St. Vincent Hospitals and Health Care Centers
  • Blank Children's Hospital
  • Holden Comprehensive Cancer Center at University of Iowa
  • Wesley Medical Center
  • Markey Cancer Center at University of Kentucky Chandler Medical Center
  • Kosair Children's Hospital
  • MBCCOP - LSU Health Sciences Center
  • Tulane Cancer Center at Tulane University Hospital and Clinic
  • Children's Hospital of New Orleans
  • Ochsner Cancer Institute at Ochsner Clinic Foundation
  • Pediatric Specialty Clinic at Eastern Maine Medical Center
  • Maine Children's Cancer Program
  • Greenebaum Cancer Center at University of Maryland Medical Center
  • Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Walter Reed Army Medical Center
  • Floating Hospital for Children
  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
  • Baystate Regional Cancer Program at D'Amour Center for Cancer Care
  • UMASS Memorial Cancer Center - University Campus
  • University of Michigan Comprehensive Cancer Center
  • Children's Hospital of Michigan
  • Van Elslander Cancer Center at St. John Hospital and Medical Center
  • Hurley Medical Center
  • DeVos Children's Hospital
  • Bronson Methodist Hospital
  • Breslin Cancer Center at Ingham Regional Medical Center
  • William Beaumont Hospital - Royal Oak Campus
  • St. Mary's - Duluth Clinic Cancer Center
  • Children's Hospitals and Clinics - Minneapolis/St. Paul
  • Mayo Clinic Cancer Center
  • University of Mississippi Medical Center
  • Children's Mercy Hospital
  • Cardinal Glennon Children's Hospital
  • St. Louis Children's Hospital
  • CCOP - Montana Cancer Consortium
  • Great Falls Clinic
  • Sletten Regional Cancer Institute
  • Children's Hospital of Omaha
  • UNMC Eppley Cancer Center at the University of Nebraska Medical Center
  • Sunrise Hospital and Medical Center
  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
  • Cancer Center at Hackensack University Medical Center
  • St. Barnabas Medical Center
  • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
  • Newark Beth Israel Medical Center
  • St. Joseph's Hospital and Medical Center
  • Valerie Fund Children's Center at Atlantic Health
  • University of New Mexico Cancer Research and Treatment Center
  • Children's Hospital at Albany Medical Center
  • Albert Einstein Cancer Center at Albert Einstein College of Medicine
  • Brooklyn Hospital Center
  • SUNY Downstate Medical Center
  • Brookdale University Hospital and Medical Center
  • Comprehensive Cancer Center at Maimonides Medical Center
  • Roswell Park Cancer Institute
  • Schneider Children's Hospital
  • Memorial Sloan-Kettering Cancer Center
  • New York Weill Cornell Cancer Center at Cornell University
  • Mount Sinai Medical Center
  • Herbert Irving Comprehensive Cancer Center at Columbia University
  • James P. Wilmot Cancer Center at University of Rochester Medical Center
  • Long Island Cancer Center at Stony Brook University Hospital
  • SUNY Upstate Medical University Hospital
  • New York Medical College
  • Mission Hospitals - Memorial Campus
  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
  • Blumenthal Cancer Center at Carolinas Medical Center
  • Presbyterian Cancer Center at Presbyterian Hospital
  • Duke Comprehensive Cancer Center
  • Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
  • Dakota Cancer Institute at Innovis Health - Dakota Clinic
  • Children's Hospital Medical Center of Akron
  • Cincinnati Children's Hospital Medical Center
  • Cleveland Clinic Taussig Cancer Center
  • Columbus Children's Hospital
  • Children's Medical Center - Dayton
  • Toledo Children's Hospital
  • Tod Children's Hospital - Forum Health
  • Children's Hospital at Oklahoma University Medical Center
  • Natalie Warren Bryant Cancer Center at St. Francis Hospital
  • CCOP - Columbia River Oncology Program
  • Legacy Emanuel Hospital and Health Center & Children's Hospital
  • Doernbecher Children's Hospital at Oregon Health & Science University
  • Geisinger Medical Center
  • Penn State Children's Hospital
  • Children's Hospital of Philadelphia
  • St. Christopher's Hospital for Children
  • Children's Hospital of Pittsburgh
  • Hollings Cancer Center at Medical University of South Carolina
  • Palmetto Health South Carolina Cancer Center
  • Children's Hospital of Greenville Hospital System
  • Avera Cancer Institute
  • Sioux Valley Hospital and University of South Dakota Medical Center
  • East Tennessee State University Cancer Center at Johnson City Medical Center
  • East Tennessee Children's Hospital
  • St. Jude Children's Research Hospital
  • Vanderbilt Children's Hospital
  • Texas Tech University Health Sciences Center School of Medicine
  • Medical City Dallas Hospital
  • Simmons Cancer Center at University of Texas Southwestern Medical Center at Dallas
  • Brooke Army Medical Center
  • Cook Children's Medical Center - Fort Worth
  • University of Texas Medical Branch
  • M.D. Anderson Cancer Center at University of Texas
  • Baylor College of Medicine
  • San Antonio Military Pediatric Cancer and Blood Disorders Center
  • Wilford Hall Medical Center
  • Covenant Children's Hospital
  • University of Texas Health Science Center at San Antonio
  • MBCCOP - South Texas Pediatrics
  • Methodist Cancer Center at Methodist Specialty and Transplant Hospital
  • CCOP - Scott and White Hospital
  • Center for Cancer Prevention and Care at Scott and White Clinic
  • Huntsman Cancer Institute at University of Utah
  • Vermont Cancer Center at University of Vermont
  • Cancer Center at the University of Virginia
  • INOVA Fairfax Hospital
  • Children's Hospital of the King's Daughters
  • Naval Medical Center - Portsmouth
  • Massey Cancer Center at Virginia Commonwealth University
  • Carilion Medical Center for Children at Roanoke Community Hospital
  • St. Joseph Hospital Community Cancer Center
  • Olympic Hematology and Oncology
  • Cancer Care Center at Skagit Valley Hospital
  • Harborview Medical Center
  • Children's Hospital and Regional Medical Center - Seattle
  • Fred Hutchinson Cancer Research Center
  • Group Health Central Hospital
  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
  • University Cancer Center at University of Washington Medical Center
  • Cancer Care Northwest - Spokane South
  • Deaconess Medical Center
  • Madigan Army Medical Center
  • Central Washington Hospital
  • Wenatchee Valley Clinic
  • West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
  • Cabell Huntington Hospital
  • Mary Babb Randolph Cancer Center at West Virginia University Hospitals
  • Bellin Memorial Hospital
  • CCOP - St. Vincent Hospital Cancer Center, Green Bay
  • St. Vincent Hospital
  • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
  • Medical College of Ohio Cancer Institute
  • University of Wisconsin Comprehensive Cancer Center
  • Marshfield Clinic - Marshfield Center
  • CCOP - Marshfield Clinic Research Foundation
  • Midwest Children's Cancer Center
  • Sydney Children's Hospital
  • Children's Hospital at Westmead
  • Royal Children's Hospital
  • Women's and Children's Hospital
  • Royal Children's Hospital
  • Princess Margaret Hospital for Children
  • Alberta Children's Hospital
  • Cross Cancer Institute at University of Alberta
  • British Columbia Children's Hospital
  • CancerCare Manitoba
  • Janeway Children's Health and Rehabilitation Centre
  • IWK Health Centre
  • McMaster Children's Hospital at Hamilton Health Sciences
  • Children's Hospital of Western Ontario
  • Children's Hospital of Eastern Ontario
  • Hospital for Sick Children
  • Montreal Children's Hospital at McGill University Health Center
  • Hopital Sainte Justine
  • Allan Blair Cancer Centre at Pasqua Hospital
  • Saskatoon Cancer Centre
  • University Medical Center Groningen
  • Starship Children's Health
  • Puerto Rico Cancer Center at University of Puerto Rico - Medical Sciences Campus
  • San Jorge Children's Hospital
  • Swiss Pediatric Oncology Group Bern
  • Swiss Pediatric Oncology Group Geneva
  • Swiss Pediatric Oncology Group Lausanne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Regimen A

Regimen B

Arm Description

Test the hypothesis that chemotherapy given every two weeks (Regimen B) will produce higher event-free survival. Treatment will occur in two phases: Induction and Continuation, with 14 cycles of chemotherapy in all. Induction consists of the first twelve weeks (four cycles on Regimen A. The cycles alternate between vincristine sulfate, doxorubicin hydrochloride, cyclophosphamide, MESNA and ifosfamide, etoposide, MESNA. G-CSF (Filgrastim) is given between chemotherapy doses. Local control (Surgery, Radiation Therapy, or a combination) will begin on Week 13 which will be after four cycles of chemotherapy.

Conventional every-three-week chemotherapy for patients with Ewing sarcoma and related tumors. Treatment will occur in two phases: Induction and Continuation, with 14 cycles of chemotherapy in all. Induction consists of the first twelve weeks six cycles on Regimen B). The cycles alternate between vincristine sulfate, doxorubicin hydrochloride, cyclophosphamide, MESNA and ifosfamide etoposide MESNA. G-CSF (Filgrastim) is given between chemotherapy doses. Local control (surgery, Radiation Therapy, or a combination) will begin on Week 13, which will be after six cycles of chemotherapy.

Outcomes

Primary Outcome Measures

Event-free survival
Assessed using a two sided log rank test of 0.05.

Secondary Outcome Measures

Full Information

First Posted
December 6, 2000
Last Updated
August 1, 2023
Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI), SWOG Cancer Research Network
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1. Study Identification

Unique Protocol Identification Number
NCT00006734
Brief Title
Comparison of Combination Chemotherapy Regimens in Treating Patients With Ewing's Sarcoma or Neuroectodermal Tumor
Official Title
Trial of Chemotherapy Intensification Through Compression in Ewing's Sarcoma and Related Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 2001 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI), SWOG Cancer Research Network

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy work in 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. It is not yet known which chemotherapy regimen combined with radiation therapy and/or surgery is more effective in treating Ewing's sarcoma or primitive neuroectodermal tumor. PURPOSE: Randomized phase III trial to compare the effectiveness of different chemotherapy regimens combined with radiation therapy and/or surgery in treating patients who have Ewing's sarcoma or primitive neuroectodermal tumor.
Detailed Description
OBJECTIVES: Compare the effect of interval-compressed vs standard chemotherapy in terms of event-free survival and overall survival in patients with newly diagnosed, localized Ewing's sarcoma or peripheral primitive neuroectodermal tumor. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (under 18 years vs 18 years and over) and location of primary disease (pelvic vs nonpelvic). Patients are randomized to 1 of 2 treatment arms for induction and continuation therapy. Induction therapy (weeks 1-12): Arm I: Patients receive alternating courses of chemotherapy consisting of vincristine IV on day 1, doxorubicin IV continuously over 48 hours on days 1 and 2, and cyclophosphamide IV over 1 hour on day 1 for courses 1 and 3 and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 for courses 2 and 4. Beginning 24 hours after the last dose of chemotherapy for each course, patients receive filgrastim (G-CSF) subcutaneously (SC) daily until blood counts recover. Treatment continues every 3 weeks for 4 courses. Arm II: Patients receive alternating courses of chemotherapy consisting of vincristine, doxorubicin, and cyclophosphamide as in arm I for courses 1, 3, and 5 and ifosfamide and etoposide as in arm I for courses 2, 4, and 6. Patients also receive G-CSF as in arm I. Treatment continues every 2 weeks for 6 courses. After completion of induction therapy, patients in both arms receive local control treatment to the primary tumor. Patients receive continuation chemotherapy after surgery or concurrently with radiotherapy. Continuation therapy: Arm I (weeks 13-42): Patients receive additional alternating courses of chemotherapy as in arm I of induction therapy with the exception of vincristine and cyclophosphamide alone for courses 7 and/or 11 and/or 13. Patients also receive G-CSF as in induction therapy. Treatment continues every 3 weeks for 10 courses. Arm II (weeks 13-29): Patients receive additional alternating courses of chemotherapy as in arm II of induction therapy with the exception of vincristine and cyclophosphamide alone for courses 9 and/or 11 and/or 13. Patients also receive G-CSF as in induction therapy. Treatment continues every 2 weeks for 8 courses. Patients are followed every 3 months for 4 years and then every 6 months for 1 year. PROJECTED ACCRUAL: Approximately 528 patients will be accrued for this study within 4-5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
Keywords
localized Ewing sarcoma/peripheral primitive neuroectodermal tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
587 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regimen A
Arm Type
Experimental
Arm Description
Test the hypothesis that chemotherapy given every two weeks (Regimen B) will produce higher event-free survival. Treatment will occur in two phases: Induction and Continuation, with 14 cycles of chemotherapy in all. Induction consists of the first twelve weeks (four cycles on Regimen A. The cycles alternate between vincristine sulfate, doxorubicin hydrochloride, cyclophosphamide, MESNA and ifosfamide, etoposide, MESNA. G-CSF (Filgrastim) is given between chemotherapy doses. Local control (Surgery, Radiation Therapy, or a combination) will begin on Week 13 which will be after four cycles of chemotherapy.
Arm Title
Regimen B
Arm Type
Experimental
Arm Description
Conventional every-three-week chemotherapy for patients with Ewing sarcoma and related tumors. Treatment will occur in two phases: Induction and Continuation, with 14 cycles of chemotherapy in all. Induction consists of the first twelve weeks six cycles on Regimen B). The cycles alternate between vincristine sulfate, doxorubicin hydrochloride, cyclophosphamide, MESNA and ifosfamide etoposide MESNA. G-CSF (Filgrastim) is given between chemotherapy doses. Local control (surgery, Radiation Therapy, or a combination) will begin on Week 13, which will be after six cycles of chemotherapy.
Intervention Type
Biological
Intervention Name(s)
filgrastim
Other Intervention Name(s)
GRANULOCYTE COLONY-STIMULATING FACTOR, r-metHuG-CSF, G-CSF, Neupogen, NSC 614629
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Other Intervention Name(s)
CTX, Cytoxan, NSC #026271
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Other Intervention Name(s)
Adriamycin, NSC #123127, IND #7038
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
etoposide
Other Intervention Name(s)
VP-16, VePesid, Etopophos, NSC #141540
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
ifosfamide
Other Intervention Name(s)
Ifex, NSC #109724
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate
Other Intervention Name(s)
Oncovin, NSC #067574
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy
Intervention Type
Radiation
Intervention Name(s)
brachytherapy
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Event-free survival
Description
Assessed using a two sided log rank test of 0.05.
Time Frame
Time from study entry until disease progression, death without progression of disease, occurrence of a second malignant neoplasm or last follow-up, whichever comes first, assessed up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed localized Ewing's sarcoma or peripheral primitive neuroectodermal tumor (PNET) of the bone or soft tissues Diagnostic biopsy of primary tumor within 30 days of study Paraspinal or bony skull tumors of extradural origin allowed No intradural soft tissue tumors Askin's tumor of the chest wall allowed Chest wall tumors with ipsilateral pleural effusions or ipsilateral pleural-based secondary tumor nodules allowed No contralateral pleural effusions No metastatic disease or distant node involvement One pulmonary or pleural nodule greater than 1 cm in diameter OR more than 1 nodule greater than 0.5 cm in diameter are considered pulmonary metastasis Solitary lung nodules of 0.5-1 cm OR multiple nodules of 0.3-0.5 cm allowed unless biopsy positive for tumor Light microscopic appearance (hematoxylin and eosin stained) consistent with Ewing's sarcoma or peripheral PNET No immunohistochemical or ultrastructural evidence of rhabdomyosarcoma No esthesioneuroblastoma Clinically or pathologically involved regional lymph nodes allowed No CNS involvement PATIENT CHARACTERISTICS: Age: 50 and under at diagnosis Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine normal for age Creatinine clearance or isotope glomerular filtration rate at least 75 mL/min Cardiovascular: Shortening fraction at least 28% by echocardiography OR Ejection fraction at least 55% by radionuclide angiogram Other: Not pregnant or nursing Fertile patients must use effective contraception No other prior malignancy except skin cancer diagnosed at least 5 years ago and currently in remission PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy for skin cancer No concurrent sargramostim (GM-CSF) No concurrent pegfilgrastim Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Prior complete or partial excision of primary tumor allowed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard B. Womer, MD
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Study Chair
Facility Information:
Facility Name
Comprehensive Cancer Center at University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of South Alabama Cancer Research Institute
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Arizona Cancer Center at University of Arizona Health Sciences Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Southern California Permanente Medical Group
City
Downey
State/Province
California
ZIP/Postal Code
90242
Country
United States
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
Facility Name
Rebecca and John Moores UCSD Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0658
Country
United States
Facility Name
Loma Linda University Cancer Institute at Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
City
Long Beach
State/Province
California
ZIP/Postal Code
90801-1428
Country
United States
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027-0700
Country
United States
Facility Name
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Jonsson Comprehensive Cancer Center at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Facility Name
Children's Hospital Central California
City
Madera
State/Province
California
ZIP/Postal Code
93638-8762
Country
United States
Facility Name
Children's Hospital and Research Center at Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94609-1809
Country
United States
Facility Name
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Lucile Packard Children's Hospital at Stanford University Medical Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Sutter Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
University of California Davis Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Kaiser Permanente Medical Center - Sacramento
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Children's Hospital and Health Center - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123-4282
Country
United States
Facility Name
UCSF Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Santa Barbara Cottage Hospital
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93102
Country
United States
Facility Name
Kaiser Permanente Medical Center - Santa Clara
City
Santa Clara
State/Province
California
ZIP/Postal Code
95051-5386
Country
United States
Facility Name
General Robert Huyser Cancer Center at David Grant Medical Center
City
Travis Air Force Base
State/Province
California
ZIP/Postal Code
94535
Country
United States
Facility Name
Children's Hospital Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Presbyterian - St. Luke's Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06360-7106
Country
United States
Facility Name
Yale Comprehensive Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520-8064
Country
United States
Facility Name
Alfred I. duPont Hospital for Children
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19899
Country
United States
Facility Name
Lombardi Cancer Center at Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010-2970
Country
United States
Facility Name
Broward General Medical Center
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Children's Hospital of Southwest Florida
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33908
Country
United States
Facility Name
University of Florida Shands Cancer Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0296
Country
United States
Facility Name
Joe DiMaggio Children's Hospital at Memorial
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Nemours Children's Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Jackson Memorial Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Miami Children's Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Baptist-South Miami Regional Cancer Program
City
Miami
State/Province
Florida
ZIP/Postal Code
33176-2197
Country
United States
Facility Name
Florida Hospital Cancer Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Nemours Children's Clinic-Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Sacred Heart Children's Hospital
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
All Children's Hospital
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
St. Joseph's Children's Hospital of Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33677-4227
Country
United States
Facility Name
Kaplan Cancer Center at St. Mary's Medical Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
MBCCOP-Medical College of Georgia Cancer Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912-4000
Country
United States
Facility Name
Medical Center of Central Georgia
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Cancer Research Center of Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Tripler Army Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96859-5000
Country
United States
Facility Name
St. Luke's Mountain States Tumor Institute - Boise
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60601
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Illinois Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Children's Memorial Hospital - Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
Advocate Hope Children's Hospital
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Lutheran General Cancer Care Center
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068-1174
Country
United States
Facility Name
Saint Jude Midwest Affiliate
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Southern Illinois University School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62794-9658
Country
United States
Facility Name
Riley Children Cancer Center at Riley Hospital for Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5225
Country
United States
Facility Name
St. Vincent Hospitals and Health Care Centers
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Blank Children's Hospital
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50308
Country
United States
Facility Name
Holden Comprehensive Cancer Center at University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1009
Country
United States
Facility Name
Wesley Medical Center
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Markey Cancer Center at University of Kentucky Chandler Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0284
Country
United States
Facility Name
Kosair Children's Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202-3830
Country
United States
Facility Name
MBCCOP - LSU Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Tulane Cancer Center at Tulane University Hospital and Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Children's Hospital of New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70118
Country
United States
Facility Name
Ochsner Cancer Institute at Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Pediatric Specialty Clinic at Eastern Maine Medical Center
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Maine Children's Cancer Program
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074-9308
Country
United States
Facility Name
Greenebaum Cancer Center at University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201-1595
Country
United States
Facility Name
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-7223
Country
United States
Facility Name
Walter Reed Army Medical Center
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20910
Country
United States
Facility Name
Floating Hospital for Children
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Baystate Regional Cancer Program at D'Amour Center for Cancer Care
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
UMASS Memorial Cancer Center - University Campus
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0914
Country
United States
Facility Name
Children's Hospital of Michigan
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Van Elslander Cancer Center at St. John Hospital and Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Hurley Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
DeVos Children's Hospital
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Bronson Methodist Hospital
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-5364
Country
United States
Facility Name
Breslin Cancer Center at Ingham Regional Medical Center
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
William Beaumont Hospital - Royal Oak Campus
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073-6769
Country
United States
Facility Name
St. Mary's - Duluth Clinic Cancer Center
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Children's Hospitals and Clinics - Minneapolis/St. Paul
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216-4505
Country
United States
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Cardinal Glennon Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
St. Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
CCOP - Montana Cancer Consortium
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Great Falls Clinic
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Sletten Regional Cancer Institute
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Children's Hospital of Omaha
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-2168
Country
United States
Facility Name
Sunrise Hospital and Medical Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Cancer Center at Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
St. Barnabas Medical Center
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Facility Name
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Newark Beth Israel Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112-2094
Country
United States
Facility Name
St. Joseph's Hospital and Medical Center
City
Paterson
State/Province
New Jersey
ZIP/Postal Code
07503
Country
United States
Facility Name
Valerie Fund Children's Center at Atlantic Health
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States
Facility Name
University of New Mexico Cancer Research and Treatment Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Children's Hospital at Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Albert Einstein Cancer Center at Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Brooklyn Hospital Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201-5493
Country
United States
Facility Name
SUNY Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Brookdale University Hospital and Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11212
Country
United States
Facility Name
Comprehensive Cancer Center at Maimonides Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
Facility Name
Schneider Children's Hospital
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
New York Weill Cornell Cancer Center at Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Herbert Irving Comprehensive Cancer Center at Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
James P. Wilmot Cancer Center at University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Long Island Cancer Center at Stony Brook University Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8174
Country
United States
Facility Name
SUNY Upstate Medical University Hospital
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Mission Hospitals - Memorial Campus
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Blumenthal Cancer Center at Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28232-2861
Country
United States
Facility Name
Presbyterian Cancer Center at Presbyterian Hospital
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28233
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27858-4354
Country
United States
Facility Name
Dakota Cancer Institute at Innovis Health - Dakota Clinic
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103-4940
Country
United States
Facility Name
Children's Hospital Medical Center of Akron
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308-1062
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Columbus Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205-2696
Country
United States
Facility Name
Children's Medical Center - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45404
Country
United States
Facility Name
Toledo Children's Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43601
Country
United States
Facility Name
Tod Children's Hospital - Forum Health
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44501
Country
United States
Facility Name
Children's Hospital at Oklahoma University Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Natalie Warren Bryant Cancer Center at St. Francis Hospital
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
CCOP - Columbia River Oncology Program
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Legacy Emanuel Hospital and Health Center & Children's Hospital
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Doernbecher Children's Hospital at Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822-1320
Country
United States
Facility Name
Penn State Children's Hospital
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
St. Christopher's Hospital for Children
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19134-1095
Country
United States
Facility Name
Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Hollings Cancer Center at Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425-0721
Country
United States
Facility Name
Palmetto Health South Carolina Cancer Center
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Children's Hospital of Greenville Hospital System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Avera Cancer Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105-1080
Country
United States
Facility Name
Sioux Valley Hospital and University of South Dakota Medical Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117-5039
Country
United States
Facility Name
East Tennessee State University Cancer Center at Johnson City Medical Center
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37614-0622
Country
United States
Facility Name
East Tennessee Children's Hospital
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37901
Country
United States
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
Vanderbilt Children's Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6310
Country
United States
Facility Name
Texas Tech University Health Sciences Center School of Medicine
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Medical City Dallas Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Simmons Cancer Center at University of Texas Southwestern Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9063
Country
United States
Facility Name
Brooke Army Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
Cook Children's Medical Center - Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0209
Country
United States
Facility Name
M.D. Anderson Cancer Center at University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
San Antonio Military Pediatric Cancer and Blood Disorders Center
City
Lackland Air Force Base
State/Province
Texas
ZIP/Postal Code
78236
Country
United States
Facility Name
Wilford Hall Medical Center
City
Lackland Air Force Base
State/Province
Texas
ZIP/Postal Code
78236
Country
United States
Facility Name
Covenant Children's Hospital
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Facility Name
MBCCOP - South Texas Pediatrics
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3900
Country
United States
Facility Name
Methodist Cancer Center at Methodist Specialty and Transplant Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3902
Country
United States
Facility Name
CCOP - Scott and White Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Center for Cancer Prevention and Care at Scott and White Clinic
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Huntsman Cancer Institute at University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Vermont Cancer Center at University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401-3498
Country
United States
Facility Name
Cancer Center at the University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
INOVA Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042-3300
Country
United States
Facility Name
Children's Hospital of the King's Daughters
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Naval Medical Center - Portsmouth
City
Portsmouth
State/Province
Virginia
ZIP/Postal Code
23708-5100
Country
United States
Facility Name
Massey Cancer Center at Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0212
Country
United States
Facility Name
Carilion Medical Center for Children at Roanoke Community Hospital
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24029
Country
United States
Facility Name
St. Joseph Hospital Community Cancer Center
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
Olympic Hematology and Oncology
City
Bremerton
State/Province
Washington
ZIP/Postal Code
98310
Country
United States
Facility Name
Cancer Care Center at Skagit Valley Hospital
City
Mount Vernon
State/Province
Washington
ZIP/Postal Code
98273
Country
United States
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Children's Hospital and Regional Medical Center - Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1024
Country
United States
Facility Name
Group Health Central Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98112
Country
United States
Facility Name
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
City
Seattle
State/Province
Washington
ZIP/Postal Code
98114
Country
United States
Facility Name
University Cancer Center at University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Cancer Care Northwest - Spokane South
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Deaconess Medical Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99210-0248
Country
United States
Facility Name
Madigan Army Medical Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431-0001
Country
United States
Facility Name
Central Washington Hospital
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
Wenatchee Valley Clinic
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25302
Country
United States
Facility Name
Cabell Huntington Hospital
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Facility Name
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506-9300
Country
United States
Facility Name
Bellin Memorial Hospital
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301
Country
United States
Facility Name
CCOP - St. Vincent Hospital Cancer Center, Green Bay
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301
Country
United States
Facility Name
St. Vincent Hospital
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54307-9070
Country
United States
Facility Name
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Facility Name
Medical College of Ohio Cancer Institute
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-6164
Country
United States
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-6164
Country
United States
Facility Name
Marshfield Clinic - Marshfield Center
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449-5772
Country
United States
Facility Name
CCOP - Marshfield Clinic Research Foundation
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Midwest Children's Cancer Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Sydney Children's Hospital
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Children's Hospital at Westmead
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Royal Children's Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Women's and Children's Hospital
City
North Adelaide
State/Province
South Australia
ZIP/Postal Code
5006
Country
Australia
Facility Name
Royal Children's Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Princess Margaret Hospital for Children
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6001
Country
Australia
Facility Name
Alberta Children's Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2T 5C7
Country
Canada
Facility Name
Cross Cancer Institute at University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
British Columbia Children's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Janeway Children's Health and Rehabilitation Centre
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3J 3G9
Country
Canada
Facility Name
McMaster Children's Hospital at Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4J9
Country
Canada
Facility Name
Children's Hospital of Western Ontario
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 2V5
Country
Canada
Facility Name
Children's Hospital of Eastern Ontario
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
Country
Canada
Facility Name
Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Name
Montreal Children's Hospital at McGill University Health Center
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
Hopital Sainte Justine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Facility Name
Allan Blair Cancer Centre at Pasqua Hospital
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 7T1
Country
Canada
Facility Name
Saskatoon Cancer Centre
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 4H4
Country
Canada
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands
Facility Name
Starship Children's Health
City
Auckland
Country
New Zealand
Facility Name
Puerto Rico Cancer Center at University of Puerto Rico - Medical Sciences Campus
City
San Juan
ZIP/Postal Code
00936-5067
Country
Puerto Rico
Facility Name
San Jorge Children's Hospital
City
Santurce
ZIP/Postal Code
00912
Country
Puerto Rico
Facility Name
Swiss Pediatric Oncology Group Bern
City
Bern
ZIP/Postal Code
CH 3010
Country
Switzerland
Facility Name
Swiss Pediatric Oncology Group Geneva
City
Geneva
ZIP/Postal Code
CH 1211
Country
Switzerland
Facility Name
Swiss Pediatric Oncology Group Lausanne
City
Lausanne
ZIP/Postal Code
CH 1011
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
20308669
Citation
van Doorninck JA, Ji L, Schaub B, Shimada H, Wing MR, Krailo MD, Lessnick SL, Marina N, Triche TJ, Sposto R, Womer RB, Lawlor ER. Current treatment protocols have eliminated the prognostic advantage of type 1 fusions in Ewing sarcoma: a report from the Children's Oncology Group. J Clin Oncol. 2010 Apr 20;28(12):1989-94. doi: 10.1200/JCO.2009.24.5845. Epub 2010 Mar 22.
Results Reference
background
PubMed Identifier
23091096
Citation
Womer RB, West DC, Krailo MD, Dickman PS, Pawel BR, Grier HE, Marcus K, Sailer S, Healey JH, Dormans JP, Weiss AR. Randomized controlled trial of interval-compressed chemotherapy for the treatment of localized Ewing sarcoma: a report from the Children's Oncology Group. J Clin Oncol. 2012 Nov 20;30(33):4148-54. doi: 10.1200/JCO.2011.41.5703. Epub 2012 Oct 22. Erratum In: J Clin Oncol. 2015 Mar 1;33(7):814. Dosage error in article text.
Results Reference
result
PubMed Identifier
21480204
Citation
Borinstein SC, Barkauskas DA, Krailo M, Scher D, Scher L, Schlottmann S, Kallakury B, Dickman PS, Pawel BR, West DC, Womer RB, Toretsky JA. Investigation of the insulin-like growth factor-1 signaling pathway in localized Ewing sarcoma: a report from the Children's Oncology Group. Cancer. 2011 Nov 1;117(21):4966-76. doi: 10.1002/cncr.26112. Epub 2011 Apr 8.
Results Reference
result
Citation
Womer RB, West DC, Krailo MD, et al.: Randomized comparison of every-two-week v. every-three-week chemotherapy in Ewing sarcoma family tumors (ESFT). [Abstract] J Clin Oncol 26 (Suppl 15): A-10504, 2008.
Results Reference
result
PubMed Identifier
28787430
Citation
Mora J, Castaneda A, Perez-Jaume S, Lopez-Pousa A, Maradiegue E, Valverde C, Martin-Broto J, Garcia Del Muro X, Cruz O, Cruz J, Martinez-Trufero J, Maurel J, Vaz MA, de Alava E, de Torres C. GEIS-21: a multicentric phase II study of intensive chemotherapy including gemcitabine and docetaxel for the treatment of Ewing sarcoma of children and adults: a report from the Spanish sarcoma group (GEIS). Br J Cancer. 2017 Sep 5;117(6):767-774. doi: 10.1038/bjc.2017.252. Epub 2017 Aug 8.
Results Reference
derived

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Comparison of Combination Chemotherapy Regimens in Treating Patients With Ewing's Sarcoma or Neuroectodermal Tumor

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