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Comparison of Chemotherapy Regimens in Treating Children With Relapsed or Progressive Rhabdomyosarcoma
This study is ongoing, but not recruiting participants.
First Received: October 11, 2001   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: NCT00025363
  Purpose

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Randomized phase II trial to compare the effectiveness of different combination chemotherapy regimens in treating children who have rhabdomyosarcoma.


Condition Intervention Phase
Sarcoma
Biological: filgrastim
Biological: sargramostim
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: ifosfamide
Drug: irinotecan hydrochloride
Drug: tirapazamine
Drug: vincristine sulfate
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: A Groupwide Randomized Phase II Window Study of Two Different Schedules of Irinotecan in Combination With Vincristine And Pilot Assessment of Safety and Efficacy of Tirapazamine Combined With Multiagent Chemotherapy for First Relapse or Progressive Disease in Rhabdomyosarcoma and Related Tumors

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Safety [ Designated as safety issue: Yes ]
  • Response at week 6 of investigational window therapy [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Designated as safety issue: Yes ]
  • Blood metabolite SN-38 levels [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Survival [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: November 2001
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed rhabdomyosarcoma, undifferentiated sarcoma, or ectomesenchymoma

    • First relapse or first occurrence of disease progression
  • Unfavorable-risk patients eligible for study window therapy with irinotecan and vincristine meeting the following criteria:

    • Unfavorable risk defined by any of the following:

      • Embryonal histology with stage I or group I at initial diagnosis with distant recurrence or with local or regional recurrence after prior cyclophosphamide
      • Embryonal histology with initial stage II, III, or IV or group II, III, or IV with any relapse pattern
      • Alveolar histology with any stage or group at initial diagnosis
    • At least unidimensionally measurable disease
    • No prior irinotecan
    • Bone marrow must not be only site of relapse OR
  • Unfavorable-risk patients ineligible for study window therapy with irinotecan meeting the following criteria:

    • Either no measurable disease OR patient received prior irinotecan
    • Bone marrow as only site of relapse allowed OR
  • Favorable-risk patients meeting the following criteria:

    • Initial botryoid histology (any stage, any group, or any pattern of relapse)
    • Embryonal histology if either stage I or group I (with either local or regional recurrence)
    • No prior cyclophosphamide
  • No CNS metastases

PATIENT CHARACTERISTICS:

Age:

  • Under 21 at time of initial diagnosis

Performance status:

  • ECOG 0-2
  • Zubrod 0-2

Life expectancy:

  • At least 2 months

Hematopoietic:

  • Absolute neutrophil count at least 750/mm^3
  • Platelet count at least 75,000/mm^3 (transfusion independent)
  • Hemoglobin at least 10.0 g/dL (red blood cell transfusion allowed)

Hepatic:

  • Bilirubin no greater than 1.5 times normal
  • SGPT less than 2.5 times normal

Renal:

  • Creatinine no greater than 1.5 times normal OR
  • Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min

Cardiovascular:

  • Shortening fraction at least 27% by echocardiogram OR
  • Ejection fraction at least 50% by MUGA
  • No prior ischemic heart disease

Other:

  • Seizure disorder allowed if well controlled by anticonvulsants
  • No CNS toxicity greater than grade 2
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior myeloablative therapy with stem cell transplantation
  • At least 1 week since prior antineoplastic biologic agent
  • At least 1 week since prior growth factor(s)
  • Recovered from prior immunotherapy
  • No concurrent immunomodulating agents

Chemotherapy:

  • See Disease Characteristics
  • See Biologic therapy
  • No more than 1 prior chemotherapy regimen
  • No prior doxorubicin or daunorubicin
  • At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered
  • No other concurrent anticancer chemotherapy

Endocrine therapy:

  • Concurrent corticosteroid therapy allowed

Radiotherapy:

  • At least 2 weeks since prior small-port radiotherapy.
  • At least 6 months since prior radiotherapy to 50% or more of pelvis
  • At least 6 weeks since other prior substantial radiotherapy to bone marrow
  • Recovered from prior radiotherapy
  • Concurrent radiotherapy to localized painful lesions allowed provided at least 1 measurable lesion is not irradiated
  • No concurrent intensity-modulated radiotherapy

Surgery:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00025363

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
United States, Arizona
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016-7710
United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Children's Hospital and Health Center - San Diego
San Diego, California, United States, 92123-4282
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Children's Hospital Central California
Madera, California, United States, 93638-8762
Children's Hospital of Orange County
Orange, California, United States, 92868
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
Long Beach, California, United States, 90801
Children's Hospital and Research Center - Oakland
Oakland, California, United States, 94609-1809
Kaiser Permanente Medical Center - Oakland
Sacramento, California, United States, 95825
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Santa Barbara Cottage Children's Hospital
Santa Barbara, California, United States, 93105
Southern California Permanente Medical Group
Downey, California, United States, 90242-2814
Stanford Cancer Center at Stanford University Medical Center
Stanford, California, United States, 94305
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, Connecticut
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
Farmington, Connecticut, United States, 06360-2875
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
United States, Florida
All Children's Hospital
St. Petersburg, Florida, United States, 33701
Baptist-South Miami Regional Cancer Program
Miami, Florida, United States, 33176
Broward General Medical Center Cancer Center
Ft. Lauderdale, Florida, United States, 33316
Florida Hospital Cancer Institute at Florida Hospital Orlando
Orlando, Florida, United States, 32803-1273
Kaplan Cancer Center at St. Mary's Medical Center
West Palm Beach, Florida, United States, 33407
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
Memorial Cancer Institute at Memorial Regional Hospital
Hollywood, Florida, United States, 33021
Miami Children's Hospital
Miami, Florida, United States, 33155
Nemours Children's Clinic - Orlando
Orlando, Florida, United States, 32806
Lee Cancer Care of Lee Memorial Health System
Fort Myers, Florida, United States, 33901
Sacred Heart Cancer Center at Sacred Heart Hospital
Pensacola, Florida, United States, 32504
St. Joseph's Cancer Institute at St. Joseph's Hospital
Tampa, Florida, United States, 33607
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32610-0232
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
United States, Georgia
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
United States, Hawaii
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 95813
United States, Idaho
St. Luke's Mountain States Tumor Institute - Boise
Boise, Idaho, United States, 83712-6297
United States, Illinois
Children's Memorial Hospital - Chicago
Chicago, Illinois, United States, 60614
Saint Jude Midwest Affiliate
Peoria, Illinois, United States, 61637
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62794-9620
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
St. Vincent Indianapolis Hospital
Indianapolis, Indiana, United States, 46260
United States, Iowa
Blank Children's Hospital
Des Moines, Iowa, United States, 50309
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1083
United States, Kansas
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7357
United States, Kentucky
Kosair Children's Hospital
Louisville, Kentucky, United States, 40232
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States, 40536-0293
United States, Louisiana
Children's Hospital of New Orleans
New Orleans, Louisiana, United States, 70118
United States, Maine
CancerCare of Maine at Eastern Maine Medial Center
Bangor, Maine, United States, 04401
Maine Children's Cancer Program
Scarborough, Maine, United States, 04074-9308
United States, Maryland
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
Baltimore, Maryland, United States, 21215
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Floating Hospital for Children at Tufts - New England Medical Center
Boston, Massachusetts, United States, 02111
United States, Michigan
Hurley Medical Center
Flint, Michigan, United States, 48503
Spectrum Health Cancer Care - Butterworth Campus
Grand Rapids, Michigan, United States, 49503-2560
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
United States, Minnesota
Children's Hospitals and Clinics of Minneapolis
Minneapolis, Minnesota, United States, 55404
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
University of Minnesota Medical Center - Fairview
Minneapolis, Minnesota, United States, 55455
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4505
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States, 65203
Siteman Cancer Center at Barnes-Jewish Hospital
St. Louis, Missouri, United States, 63110
United States, Nevada
Sunrise Hospital and Medical Center
Las Vegas, Nevada, United States, 89109-2306
United States, New Jersey
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Hackensack University Medical Center Cancer Center
Hackensack, New Jersey, United States, 07601
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
Overlook Hospital
Morristown, New Jersey, United States, 07962
St. Barnabas Medical Center
Livingston, New Jersey, United States, 07039
United States, New Mexico
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, United States, 87131-5636
United States, New York
Albert Einstein Cancer Center at Albert Einstein College of Medicine
Bronx, New York, United States, 10461
NYU Cancer Institute at New York University Medical Center
New York, New York, United States, 10016
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
New York Medical College
Valhalla, New York, United States, 10595
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States, 10032
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Stony Brook University Cancer Center
Stony Brook, New York, United States, 11794-8174
SUNY Upstate Medical University Hospital
Syracuse, New York, United States, 13210
United States, North Carolina
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States, 28801
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States, 28233-3549
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
United States, Ohio
Children's Hospital Medical Center of Akron
Akron, Ohio, United States, 44308-1062
Children's Medical Center - Dayton
Dayton, Ohio, United States, 45404-1815
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195-5217
Columbus Children's Hospital
Columbus, Ohio, United States, 43205-2696
Medical University of Ohio Cancer Center
Toledo, Ohio, United States, 43614
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106-5000
Tod Children's Hospital - Forum Health
Youngstown, Ohio, United States, 44501
Toledo Hospital
Toledo, Ohio, United States, 43606
United States, Oklahoma
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, United States, 74136
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Legacy Emanuel Hospital and Health Center & Children's Hospital
Portland, Oregon, United States, 97227
United States, Pennsylvania
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134-1095
United States, Rhode Island
Rhode Island Hospital Comprehensive Cancer Center
Providence, Rhode Island, United States, 02903
United States, South Carolina
Greenville Hospital System Cancer Center
Greenville, South Carolina, United States, 29605
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Palmetto Health South Carolina Cancer Center
Columbia, South Carolina, United States, 29203
United States, South Dakota
Sioux Valley Hospital and 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, 37916
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6310
United States, Texas
Baylor University Medical Center - Houston
Houston, Texas, United States, 77030-2399
Covenant Children's Hospital
Lubbock, Texas, United States, 79410
Children's Hospital of Austin
Austin, Texas, United States, 78701
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, United States, 76104-9958
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Methodist Children's Hospital of South Texas
San Antonio, Texas, United States, 78229-3993
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390
Texas Tech University Health Sciences Center School of Medicine - Amarillo
Amarillo, Texas, United States, 79106
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78207
United States, Utah
Primary Children's Medical Center
Salt Lake City, Utah, United States, 84113-1100
United States, Vermont
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States, 05405
United States, Virginia
Carilion Cancer Center of Western Virginia
Roanoke, Virginia, United States, 24029
Children's Hospital of the King's Daughters
Norfolk, Virginia, United States, 23507-1971
INOVA Fairfax Hospital
Fairfax, Virginia, United States, 22031
Massey Cancer Center at Virginia Commonwealth University
Richmond, Virginia, United States, 23298-0037
Naval Medical Center - Portsmouth
Portsmouth, Virginia, United States, 23708-2197
United States, Washington
Mary Bridge Children's Hospital and Health Center - Tacoma
Tacoma, Washington, United States, 98405
United States, West Virginia
Edwards Comprehensive Cancer Center at 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
United States, Wisconsin
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States, 54449
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-3508
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Australia, New South Wales
John Hunter Hospital
Newcastle, New South Wales, Australia, 2310
Westmead Institute for Cancer Research at Westmead Hospital
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Royal Children's Hospital
Herston, Brisbane, Queensland, Australia, 4029
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
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Children's & Women's Hospital of British Columbia
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Canada, Ontario
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Children's Hospital of Western Ontario
London, Ontario, Canada, N6A 4G5
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 Hospitalier Universitaire de Quebec
Ste-Foy, Quebec, Canada, G1V 4G2
Hopital Sainte Justine
Montreal, Quebec, Canada, H3T 1C5
Montreal Children's Hospital at McGill University Health Center
Montreal, Quebec, Canada, H3H 1P3
Canada, Saskatchewan
Saskatoon Cancer Centre at the University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 4H4
Puerto Rico
San Jorge Children's Hospital
Santurce, Puerto Rico, 00912
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Philip P. Breitfeld, MD Duke University
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000068954, COG-ARST0121
Study First Received: October 11, 2001
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00025363     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent childhood rhabdomyosarcoma
embryonal childhood rhabdomyosarcoma
alveolar childhood rhabdomyosarcoma
embryonal-botryoid childhood rhabdomyosarcoma
previously treated childhood rhabdomyosarcoma

Additional relevant MeSH terms:
Neoplasms, Muscle Tissue
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Irinotecan
Physiological Effects of Drugs
Cyclophosphamide
Antibiotics, Antineoplastic
Neoplasms, Connective and Soft Tissue
Therapeutic Uses
Etoposide
Alkylating Agents
Rhabdomyosarcoma
Neoplasms by Histologic Type
Myosarcoma
Mitosis Modulators
Vincristine
Enzyme Inhibitors
Antimitotic Agents
Immunosuppressive Agents
Doxorubicin
Camptothecin
Pharmacologic Actions
Ifosfamide
Neoplasms
Radiation-Sensitizing Agents
Tubulin Modulators
Myeloablative Agonists
Sarcoma
Tirapazamine

ClinicalTrials.gov processed this record on November 25, 2009