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Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Metastatic Rhabdomyosarcoma or Sarcoma
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes
Sponsor: Children's Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003955
  Purpose

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. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy combined with radiation therapy in treating patients who have metastatic rhabdomyosarcoma or sarcoma.


Condition Intervention Phase
Sarcoma
 Biological: dactinomycin
Biological: filgrastim
Biological: pegfilgrastim
Biological: sargramostim
Drug: cyclophosphamide
Drug: irinotecan hydrochloride
Drug: vincristine sulfate
Radiation: radiation therapy
 Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II "Up-Front Window Study" of Irinotecan (CPT-11) Followed by Multimodal, Multiagent, Therapy for Selected Children and Adolescents With Newly Diagnosed Stage 4/Clinical Group IV Rhabdomyosarcoma: An IRS-V Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer Soft Tissue Sarcoma
Drug Information available for: Cyclophosphamide Dactinomycin Vincristine Irinotecan U 101440E Filgrastim Sargramostim Irinotecan hydrochloride Pegfilgrastim Vincristine sulfate
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 46
Study Start Date: March 2001
Detailed Description:

OBJECTIVES:

  • Determine the response rate of patients with newly diagnosed high-risk metastatic stage IV/clinical group IV rhabdomyosarcoma treated with upfront window therapy comprising irinotecan and vincristine.
  • Determine the toxic effects of this regimen in these patients.
  • Determine the toxic effects of this regimen when given in alternating courses with vincristine, dactinomycin, and cyclophosphamide (VAC) as continuation therapy in patients with partial or complete response.
  • Determine the overall and failure-free survival of patients treated with irinotecan and vincristine followed by VAC alone or VAC alternating with vincristine and irinotecan plus radiotherapy.
  • Determine the pharmacokinetics of irinotecan and vincristine in these patients.

OUTLINE:

  • Upfront window therapy: Patients receive vincristine IV on days 1 and 8 and irinotecan IV over 60 minutes on days 1-5 and 8-12. Treatment repeats every 21 days for a total of 2 courses. Patients experiencing partial or complete response proceed to regimen A. Patients experiencing stable or progressive disease proceed to regimen B.

    • Regimen A: Patients receive vincristine IV over 1 minute weekly on weeks 6-13, 15-19, 23-27, 29, 32-35, 38-39, and 41; dactinomycin IV over 1 minute weekly on weeks 6, 12, 23, 29, 35, and 41; and cyclophosphamide IV over 30-60 minutes weekly on weeks 6, 12, 16, 19, 23, 29, 35, and 41. Patients also receive irinotecan IV over 1 hour daily, 5 days a week, on weeks 9, 10, 26, 27, 32, 33, 38, and 39 and undergo radiotherapy daily, 5 days a week, on weeks 15-22.
    • Regimen B: Patients receive vincristine as in regimen A; dactinomycin IV over 1 minute weekly on weeks 6, 9, 12, 23, 26, 29, 32, 35, 38, and 41 and cyclophosphamide IV over 30-60 minutes weekly on weeks 6, 9, 12, 16, 19, 23, 26, 29, 32, 35, 38, and 41. Patients receive radiotherapy as in regimen A.

Patients who do not receive upfront window irinotecan/vincristine therapy are treated with standard therapy.

  • Standard therapy: Patients receive vincristine IV over 1 minute weekly on weeks 0-13, 15-19, 23-27, 29, 32-35, 38, and 41; dactinomycin IV over 1 minute weekly on weeks 0, 6, 9, 12, 23, 26, 29, 32, 35, 38, and 41; and cyclophosphamide IV over 30-60 minutes weekly on weeks 0, 3, 6, 9, 12, 16, 19, 23, 26, 29, 32, 35, 38, and 41. Patients without evidence of intracranial extension receive radiotherapy once daily, 5 days a week, during weeks 15-22. Patients with evidence of intracranial extension, or who require emergency radiotherapy, receive radiotherapy during weeks 0-6. Dactinomycin is withheld during radiotherapy.

All patients receive filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously (SC) beginning 24 hours after completion of each course of chemotherapy and continuing until blood counts recover. Alternatively, patients may receive pegfilgrastim SC beginning 24-36 hours after completion of each course of chemotherapy and continuing until blood counts recover.

Patients are followed every 2 months for 1 year, every 4 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 18-46 patients will be accrued for this study within 9-24 months.

  Eligibility

Ages Eligible for Study:   up to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed metastatic stage IV/clinical group IV rhabdomyosarcoma, undifferentiated sarcoma, or ectomesenchymoma

    • No metastatic embryonal tumors in patients under 10 years of age, regardless of primary site
    • Metastatic tumors of parameningeal sites eligible
  • Bidimensionally measurable disease
  • No positive cerebrospinal fluid cytology or multiple intracranial metastases

  • Patients presenting with the following are only eligible for continuation therapy and may not receive irinotecan/vincristine upfront window therapy:

    • Evidence of base of skull erosion or skull metastatic disease that displaces or indents the dura, compresses the brain parenchyma, or causes evidence of cranial nerve palsy
    • Tumor that touches or displaces the spinal cord
    • Evidence of intracranial primary tumor extension
    • Tumors that could cause potentially life-threatening complications (e.g., renal, airway) with progression due to location and/or growth rate
    • Requires emergency radiotherapy
    • Lab values are consistent with disseminated intravascular coagulation

PATIENT CHARACTERISTICS:

Age:

  • Under 50 (alveolar rhabdomyosarcoma, undifferentiated sarcoma, and ectomesenchymoma patients)
  • 10 to 49 (embryonal histology patients)

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • See Disease Characteristics
  • Absolute neutrophil count greater than 1,000/mm^3*
  • Platelet count greater than 150,000/mm^3* NOTE: *Unless there is tumor involvement of bone marrow

Hepatic:

  • Bilirubin less than 1.5 mg/dL
  • PT, PTT, and fibrinogen less than 1.5 times upper limit of normal

Renal:

  • Creatinine less than 1.2 mg/dL

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Prior steroids allowed

Radiotherapy:

  • See Disease Characteristics
  • No prior radiotherapy

Surgery:

  • No more than 42 days since prior initial surgical procedure, including biopsy for diagnosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003955

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35233
University of South Alabama Cancer Research Institute
Mobile, Alabama, United States, 36604
United States, Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
Orange, California, United States, 92868
David Grant Medical Center
Travis Air Force Base, California, United States, 94535
Children's Hospital and Research Center at Oakland
Oakland, California, United States, 94609-1809
Children's Hospital Central California
Madera, California, United States, 93638-8762
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027-0700
Children's Hospital of Orange County
Orange, California, United States, 92868
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Children's Hospital and Health Center, San Diego
San Diego, California, United States, 92123-4282
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
Long Beach, California, United States, 90801-1428
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
Kaiser Permanente Medical Center - Sacramento
Sacramento, California, United States, 95825
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States, 95051-5386
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0658
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Lucile Packard Children's Hospital at Stanford University Medical Center
Palo Alto, California, United States, 94304
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
San Diego, California, United States, 92120
Santa Barbara Cottage Hospital
Santa Barbara, California, United States, 93102
Southern California Permanente Medical Group
Downey, California, United States, 90242
Sutter Cancer Center
Sacramento, California, United States, 95816
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
University of California Davis Cancer Center
Sacramento, California, United States, 95817
United States, Colorado
Children's Hospital of Denver
Denver, Colorado, United States, 80218-1088
Presbyterian - St. Luke's Medical Center
Denver, Colorado, United States, 80218
United States, Connecticut
University of Connecticut Comprehensive Cancer Center at University of Connecticut Health Center
Farmington, Connecticut, United States, 06360-7106
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States, 06520-8028
United States, Delaware
Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States, 19899
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010-2970
Lombardi Cancer Center at Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5001
United States, Florida
All Children's Hospital
St. Petersburg, Florida, United States, 33701
Baptist Hospital of Miami
Miami, Florida, United States, 33176-2197
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
Children's Hospital of Southwest Florida
Fort Myers, Florida, United States, 33908
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804
Jackson Memorial Hospital
Miami, Florida, United States, 33136
Joe DiMaggio Children's Hospital at Memorial
Hollywood, Florida, United States, 33021
Miami Children's Hospital
Miami, Florida, United States, 33155
Broward General Medical Center
Fort Lauderdale, Florida, United States, 33316
Nemours Children's Clinic-Orlando
Orlando, Florida, United States, 32806
Sacred Heart Children's Hospital
Pensacola, Florida, United States, 32504
Shands Cancer Center at the University of Florida Health Science Center
Gainesville, Florida, United States, 32610-0296
St. Joseph's Children's Hospital
Tampa, Florida, United States, 33677-4227
St. Mary's Hospital
West Palm Beach, Florida, United States, 33407
United States, Georgia
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus
Atlanta, Georgia, United States, 30342
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States, 31405
MBCCOP-Medical College of Georgia Cancer Center
Augusta, Georgia, United States, 30912-4000
Medical Center of Central Georgia
Macon, Georgia, United States, 31201
United States, Hawaii
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813
MBCCOP - Hawaii
Honolulu, Hawaii, United States, 96813
Tripler Army Medical Center
Honolulu, Hawaii, United States, 96859-5000
United States, Idaho
Mountain States Tumor Institute - Boise
Boise, Idaho, United States, 83712
United States, Illinois
Advocate Hope Children's Hospital
Oak Lawn, Illinois, United States, 60453
Children's Memorial Hospital - Chicago
Chicago, Illinois, United States, 60614
Lutheran General Cancer Care Center
Park Ridge, Illinois, United States, 60068-1174
Rush University Medical Center
Chicago, Illinois, United States, 60612
Saint Jude Midwest Affiliate
Peoria, Illinois, United States, 61637
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62794-9658
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60601
University of Illinois Medical Center
Chicago, Illinois, United States, 60612
United States, Indiana
Riley Children Cancer Center at Riley Hospital for Children
Indianapolis, Indiana, United States, 46202-5225
St. Vincent Hospital and Health Care Center
Indianapolis, Indiana, United States, 46260
United States, Iowa
Blank Children's Hospital
Des Moines, Iowa, United States, 50308
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1009
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
United States, Kansas
Wesley Medical Center
Wichita, Kansas, United States, 67214
United States, Kentucky
Kosair Children's Hospital
Louisville, Kentucky, United States, 40202-3830
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States, 40536-0284
United States, Louisiana
Children's Hospital of New Orleans
New Orleans, Louisiana, United States, 70118
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Tulane Cancer Center at Tulane University Hospital and Clinic
New Orleans, Louisiana, United States, 70112
United States, Maine
Eastern Maine Medical Center
Bangor, Maine, United States, 04401
Maine Children's Cancer Program
Scarborough, Maine, United States, 04074-9308
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201-1595
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21225
United States, Massachusetts
Baystate Regional Cancer Program at Baystate Medical Center
Springfield, Massachusetts, United States, 01107
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Floating Hospital for Children
Boston, Massachusetts, United States, 02111
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, United States, 01655
United States, Michigan
CCOP - Beaumont
Royal Oak, Michigan, United States, 48073-6769
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007-5364
Breslin Cancer Center at Ingham Regional Medical Center
Lansing, Michigan, United States, 48910
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
Hurley Medical Center
Flint, Michigan, United States, 48503
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
Spectrum Health and DeVos Children's Hospital
Grand Rapids, Michigan, United States, 49503
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0914
Van Elslander Cancer Center at St. John Hospital and Medical Center
Detroit, Michigan, United States, 48236
William Beaumont Hospital - Royal Oak
Royal Oak, Michigan, United States, 48073-6769
United States, Minnesota
Children's Hospitals and Clinics - Minneapolis
Minneapolis, Minnesota, United States, 55404
Children's Hospitals and Clinics - Minnesota
Saint Paul, Minnesota, United States, 55102
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
St. Mary's - Duluth Clinic Cancer Center
Duluth, Minnesota, United States, 55805
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4505
United States, Missouri
St. Louis Children's Hospital
Saint Louis, Missouri, United States, 63110
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Cardinal Glennon Children's Hospital
Saint Louis, Missouri, United States, 63104
United States, Nebraska
Children's Hospital of Omaha
Omaha, Nebraska, United States, 68114
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-2168
United States, Nevada
Sunrise Hospital and Medical Center
Las Vegas, Nevada, United States, 89109
United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112-2094
Cancer Institute of New Jersey at Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08903
Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, United States, 07503
Valerie Fund Children's Center at Atlantic Health
Summit, New Jersey, United States, 07901
United States, New Mexico
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, United States, 87131
United States, New York
Albert Einstein Clinical Cancer Center
Bronx, New York, United States, 10461
Cancer Center of Albany Medical Center
Albany, New York, United States, 12208
Brooklyn Hospital Center
Brooklyn, New York, United States, 11201-5493
Brookdale University Hospital and Medical Center
Brooklyn, New York, United States, 11212
Comprehensive Cancer Center at Maimonides Medical Center
Brooklyn, New York, United States, 11219
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States, 10032
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
Long Island Cancer Center at Stony Brook University Hospital
Stony Brook, New York, United States, 11794
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States, 10021
Mount Sinai School of Medicine
New York, New York, United States, 10029
New York Medical College
Valhalla, New York, United States, 10595
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
North Shore University Hospital
Manhasset, New York, United States, 11030
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Schneider Children's Hospital
New Hyde Park, New York, United States, 11042
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
University Hospital at State University of New York - Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1081
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina
Greenville, North Carolina, United States, 27858-4354
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
Mission Hospitals
Asheville, North Carolina, United States, 28801
Presbyterian Healthcare
Charlotte, North Carolina, United States, 28233
United States, North Dakota
Dakota Cancer Institute at Innovis Health - Dakota Clinic
Fargo, North Dakota, United States, 58103-4940
United States, Ohio
Children's Hospital Medical Center of Akron
Akron, Ohio, United States, 44308
Children's Hospital of Columbus
Columbus, Ohio, United States, 43205-2696
Toledo Children's Hospital
Toledo, Ohio, United States, 43601
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Forum Health-Tod Childrens Hospital
Youngstown, Ohio, United States, 44501
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
St. Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
Children's Medical Center - Dayton
Dayton, Ohio, United States, 45404
United States, Oklahoma
CCOP - Oklahoma
Tulsa, Oklahoma, United States, 74136
Children's Hospital at Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States, 73104
Natalie Warren Bryant Cancer Center
Tulsa, Oklahoma, United States, 74136
United States, Oregon
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97225
Doernbecher Children's Hospital at Oregon Health & Science University
Portland, Oregon, United States, 97239-3098
Legacy Emanuel Hospital and Health Center & Children's Hospital
Portland, Oregon, United States, 97227
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213-2583
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-1320
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134-1095
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South Carolina
Palmetto Health South Carolina Cancer Center
Columbia, South Carolina, United States, 29203
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425-0721
Children's Hospital of Greenville Hospital System
Greenville, South Carolina, United States, 29605
United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105-1080
Sioux Valley Hospital at University of South Dakota Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
United States, Tennessee
East Tennessee Children's Hospital
Knoxville, Tennessee, United States, 37901
East Tennessee State University Cancer Center at Johnson City Medical Center
Johnson City, Tennessee, United States, 37604
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105-2794
Vanderbilt Children's Hospital
Nashville, Tennessee, United States, 37232-6310
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
Methodist Cancer Center at Methodist Specialty and Transplant Hospital
San Antonio, Texas, United States, 78229-3902
Children's Hospital of Austin
Austin, Texas, United States, 78701
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, United States, 76104
Covenant Children's Hospital
Lubbock, Texas, United States, 79410
MBCCOP - South Texas Pediatrics
San Antonio, Texas, United States, 78229-3900
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Center for Cancer Prevention and Care at Scott and White Clinic
Temple, Texas, United States, 76508
San Antonio Military Pediatric Cancer and Blood Disorders Center
Lackland Air Force Base, Texas, United States, 78236
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390-9063
Texas Tech University Health Sciences Center School of Medicine
Amarillo, Texas, United States, 79106
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78207
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0361
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
United States, Vermont
Vermont Cancer Center at University of Vermont
Burlington, Vermont, United States, 05401-3498
United States, Virginia
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States, 22908
Carilion Medical Center for Children
Roanoke, Virginia, United States, 24029
Children's Hospital of the King's Daughters
Norfolk, Virginia, United States, 23507
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042-3300
Massey Cancer Center at Virginia Commonwealth University
Richmond, Virginia, United States, 23298-0121
Naval Medical Center, Portsmouth
Portsmouth, Virginia, United States, 23708-5100
United States, Washington
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States, 98105
Deaconess Medical Center
Spokane, Washington, United States, 99210-0248
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Group Health Central Hospital
Seattle, Washington, United States, 98112
Madigan Army Medical Center
Tacoma, Washington, United States, 98431-5000
Mary Bridge Children's Hospital and Health Center
Tacoma, Washington, United States, 98415-0299
United States, West Virginia
Cabell Huntington Hospital
Huntington, West Virginia, United States, 25701
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
Charleston, West Virginia, United States, 25302
West Virginia University Hospitals
Morgantown, West Virginia, United States, 26506-9300
United States, Wisconsin
St. Vincent Hospital
Green Bay, Wisconsin, United States, 54307-9070
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States, 54449
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, United States, 54301
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449-5772
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States, 53226
Bellin Memorial Hospital
Green Bay, Wisconsin, United States, 54301
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Australia, New South Wales
Children's Hospital at Westmead
Westmead, New South Wales, Australia, 2145
Sydney Children's Hospital
Randwick, New South Wales, Australia, 2031
Australia, Queensland
Royal Children's Hospital
Brisbane, Queensland, Australia, 4029
Australia, South Australia
Women's and Children's Hospital
North Adelaide, South Australia, Australia, 5006
Australia, Victoria
Royal Children's Hospital
Parkville, Victoria, Australia, 3052
Australia, Western Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia, 6001
Canada, Alberta
Alberta Children's Hospital
Calgary, Alberta, Canada, T2T 5C7
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
British Columbia Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Newfoundland and Labrador
Janeway Children's Health and Rehabilitation Centre
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3J 3G9
Canada, Ontario
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Children's Hospital of Western Ontario
London, Ontario, Canada, N6C 2V5
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8N 3Z5
Canada, Quebec
Centre de Recherche du Centre Hospitalier de l'Universite Laval
Sainte Foy, Quebec, Canada, GIV 4G2
Hopital Sainte Justine
Montreal, Quebec, Canada, H3T 1C5
McGill University Health Center - Montreal Children's Hospital
Montreal, Quebec, Canada, H3G 1A4
Canada, Saskatchewan
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, Canada, S4T 7T1
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4
Netherlands
Academisch Ziekenhuis Groningen
Groningen, Netherlands, 9700 RB
New Zealand
Starship Children's Hospital
Auckland, New Zealand
Puerto Rico
Puerto Rico Cancer Center at University of Puerto Rico - Medical Sciences Campus
San Juan, Puerto Rico, 00936-5067
San Jorge Childrens Hospital
Santurce, Puerto Rico, 00912
Switzerland
Swiss Pediatric Oncology Group Lausanne
Lausanne, Switzerland, CH 1011
Swiss Pediatric Oncology Group Geneva
Geneva, Switzerland, CH 1211
Swiss Pediatric Oncology Group Bern
Bern, Switzerland, CH 3010
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Alberto S. Pappo, MD Texas Children's Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:
Pappo AS, Lyden E, Breitfeld P, Donaldson SS, Wiener E, Parham D, Crews KR, Houghton P, Meyer WH; Children's Oncology Group. Two consecutive phase II window trials of irinotecan alone or in combination with vincristine for the treatment of metastatic rhabdomyosarcoma: the Children's Oncology Group. J Clin Oncol. 2007 Feb 1;25(4):362-9.
Soft Tissue Sarcoma Committee of the Children's Oncology Group; Lager JJ, Lyden ER, Anderson JR, Pappo AS, Meyer WH, Breitfeld PP. Pooled analysis of phase II window studies in children with contemporary high-risk metastatic rhabdomyosarcoma: a report from the Soft Tissue Sarcoma Committee of the Children's Oncology Group. J Clin Oncol. 2006 Jul 20;24(21):3415-22.

Study ID Numbers: CDR0000067154, COG-D9802, IRS-D9802, CCG-D9802, POG-D9802
Study First Received: November 1, 1999
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00003955     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
embryonal childhood rhabdomyosarcoma
alveolar childhood rhabdomyosarcoma
metastatic childhood soft tissue sarcoma
childhood malignant mesenchymoma
 previously untreated childhood rhabdomyosarcoma
adult rhabdomyosarcoma
adult malignant mesenchymoma
stage IV adult soft tissue sarcoma

Additional relevant MeSH terms:
Neoplasms, Muscle Tissue
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Irinotecan
Physiological Effects of Drugs
Cyclophosphamide
Antibiotics, Antineoplastic
Neoplasms, Connective and Soft Tissue
Anti-Bacterial Agents
Dactinomycin
Therapeutic Uses
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
 Rhabdomyosarcoma
Neoplasms by Histologic Type
Myosarcoma
Mitosis Modulators
Vincristine
Enzyme Inhibitors
Antimitotic Agents
Immunosuppressive Agents
Camptothecin
Pharmacologic Actions
Protein Synthesis Inhibitors
Neoplasms
Tubulin Modulators
Myeloablative Agonists
Sarcoma

ClinicalTrials.gov processed this record on November 27, 2009



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