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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

Phase 2
49 Years
Open (Enrolling)

Thank you

Trial Information

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


- 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.


- 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

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

Inclusion Criteria


- 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



- Under 50 (alveolar rhabdomyosarcoma, undifferentiated sarcoma, and ectomesenchymoma

- 10 to 49 (embryonal histology patients)

Performance status:

- Not specified

Life expectancy:

- Not specified


- 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


- Bilirubin less than 1.5 mg/dL

- PT, PTT, and fibrinogen less than 1.5 times upper limit of normal


- Creatinine less than 1.2 mg/dL


- Not pregnant or nursing

- Fertile patients must use effective contraception


Biologic therapy:

- Not specified


- No prior chemotherapy

Endocrine therapy:

- Prior steroids allowed


- See Disease Characteristics

- No prior radiotherapy


- No more than 42 days since prior initial surgical procedure, including biopsy for

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Alberto S. Pappo, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Texas Children's Cancer Center


United States: Federal Government

Study ID:




Start Date:

March 2001

Completion Date:

Related Keywords:

  • Sarcoma
  • 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
  • Rhabdomyosarcoma
  • Sarcoma



Baylor College of Medicine Houston, Texas  77030
Roswell Park Cancer Institute Buffalo, New York  14263
Fred Hutchinson Cancer Research Center Seattle, Washington  98109
Memorial Sloan-Kettering Cancer Center New York, New York  10021
University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Children's Hospital of Philadelphia Philadelphia, Pennsylvania  19104
Mayo Clinic Cancer Center Rochester, Minnesota  55905
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
MBCCOP - Hawaii Honolulu, Hawaii  96813
University of Chicago Cancer Research Center Chicago, Illinois  60637
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Cancer Center of Albany Medical Center Albany, New York  12208
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Ireland Cancer Center Cleveland, Ohio  44106-5065
Tripler Army Medical Center Honolulu, Hawaii  96859-5000
Children's Hospital of Michigan Detroit, Michigan  48201
Hurley Medical Center Flint, Michigan  48503
Mount Sinai School of Medicine New York, New York  10029
Presbyterian Healthcare Charlotte, North Carolina  28233-3549
Rhode Island Hospital Providence, Rhode Island  02903
Medical City Dallas Hospital Dallas, Texas  75230
San Antonio Military Pediatric Cancer and Blood Disorders Center Lackland Air Force Base, Texas  78236-5300
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
Midwest Children's Cancer Center Milwaukee, Wisconsin  53226
Sinai Hospital of Baltimore Baltimore, Maryland  21225
St. Vincent Hospital and Health Care Center Indianapolis, Indiana  46260
Yale Comprehensive Cancer Center New Haven, Connecticut  06520-8028
Presbyterian - St. Luke's Medical Center Denver, Colorado  80218
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods, Michigan  48236
Bronson Methodist Hospital Kalamazoo, Michigan  49007
Geisinger Medical Center Danville, Pennsylvania  17822-0001
Penn State Cancer Institute at Milton S. Hershey Medical Center Hershey, Pennsylvania  17033-0850
Avera Cancer Institute Sioux Falls, South Dakota  57105
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center La Crosse, Wisconsin  54601
University of Alabama at Birmingham Comprehensive Cancer Center Birmingham, Alabama  35294-3300
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
Cancer Center at the University of Virginia Charlottesville, Virginia  22908
Huntsman Cancer Institute Salt Lake City, Utah  84112
Marshfield Clinic Marshfield, Wisconsin  54449
David Grant Medical Center Travis Air Force Base, California  94535
Baptist Hospital of Miami Miami, Florida  33176-2197
Lutheran General Cancer Care Center Park Ridge, Illinois  60068
Newark Beth Israel Medical Center Newark, New Jersey  07112
New York Medical College Valhalla, New York  10595
University of Texas Medical Branch Galveston, Texas  77555-1329
Naval Medical Center, Portsmouth Portsmouth, Virginia  23708-2197
Deaconess Medical Center Spokane, Washington  99210-0248
St. Vincent Hospital Green Bay, Wisconsin  54307-3508
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center Orange, California  92868
Rush University Medical Center Chicago, Illinois  60612-3824
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756-0002
Long Island Cancer Center at Stony Brook University Hospital Stony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570
CCOP - Columbia River Oncology Program Portland, Oregon  97225
CCOP - Scott and White Hospital Temple, Texas  76508
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
CCOP - St. Vincent Hospital Cancer Center, Green Bay Green Bay, Wisconsin  54301
Cancer Research Center of Hawaii Honolulu, Hawaii  96813
North Shore University Hospital Manhasset, New York  11030
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
MBCCOP - LSU Health Sciences Center New Orleans, Louisiana  70112
Madigan Army Medical Center Tacoma, Washington  98431-5048
Sutter Cancer Center Sacramento, California  95816
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Children's Hospital Los Angeles Los Angeles, California  90027-0700
Children's Hospital of Orange County Orange, California  92668
Children's Hospital of Denver Denver, Colorado  80218
Children's National Medical Center Washington, District of Columbia  20010-2970
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Joe DiMaggio Children's Hospital at Memorial Hollywood, Florida  33021
Nemours Children's Clinic Jacksonville, Florida  32207
Miami Children's Hospital Miami, Florida  33155-4069
Florida Hospital Cancer Institute Orlando, Florida  32804
Nemours Children's Clinic-Orlando Orlando, Florida  32806
Sacred Heart Children's Hospital Pensacola, Florida  32504
All Children's Hospital St. Petersburg, Florida  33701
St. Mary's Hospital West Palm Beach, Florida  33407
Children's Memorial Hospital - Chicago Chicago, Illinois  60614
Advocate Hope Children's Hospital Oak Lawn, Illinois  60453
Saint Jude Midwest Affiliate Peoria, Illinois  61637
Wesley Medical Center Wichita, Kansas  67214
Children's Hospital of New Orleans New Orleans, Louisiana  70118
Ochsner Clinic Foundation New Orleans, Louisiana  70121
Maine Children's Cancer Program Scarborough, Maine  04074-9308
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute Boston, Massachusetts  02115
Floating Hospital for Children Boston, Massachusetts  02111
University of Massachusetts Memorial Medical Center - University Campus Worcester, Massachusetts  01655
Cardinal Glennon Children's Hospital Saint Louis, Missouri  63104
University of New Mexico Cancer Research and Treatment Center Albuquerque, New Mexico  87131
Schneider Children's Hospital New Hyde Park, New York  11042
St. Christopher's Hospital for Children Philadelphia, Pennsylvania  19134-1095
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St. Jude Children's Research Hospital Memphis, Tennessee  38105-2794
Cook Children's Medical Center - Fort Worth Fort Worth, Texas  76104
Inova Fairfax Hospital Falls Church, Virginia  22042-3300
Carilion Medical Center for Children Roanoke, Virginia  24029
West Virginia University Hospitals Morgantown, West Virginia  26506-9300
City of Hope Comprehensive Cancer Center Duarte, California  91010
UCSF Comprehensive Cancer Center San Francisco, California  94115
Albert Einstein Clinical Cancer Center Bronx, New York  10461
John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines, Iowa  50309
Phoenix Children's Hospital Phoenix, Arizona  85016-7710
Southern California Permanente Medical Group Downey, California  90242
Children's Hospital Central California Madera, California  93638-8762
Santa Barbara Cottage Hospital Santa Barbara, California  93102
Medical Center of Central Georgia Macon, Georgia  31201
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St. Vincent Mercy Medical Center Toledo, Ohio  43608
Toledo Children's Hospital Toledo, Ohio  43601
Forum Health-Tod Childrens Hospital Youngstown, Ohio  44501
Natalie Warren Bryant Cancer Center Tulsa, Oklahoma  74136
Palmetto Health South Carolina Cancer Center Columbia, South Carolina  29203
East Tennessee Children's Hospital Knoxville, Tennessee  37901
Texas Tech University Health Sciences Center School of Medicine Amarillo, Texas  79106
Children's Hospital of Austin Austin, Texas  78701
Covenant Children's Hospital Lubbock, Texas  79410
Children's Hospital of the King's Daughters Norfolk, Virginia  23507
Bellin Memorial Hospital Green Bay, Wisconsin  54301
Arizona Cancer Center at University of Arizona Health Sciences Center Tucson, Arizona  85724
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Markey Cancer Center at University of Kentucky Chandler Medical Center Lexington, Kentucky  40536-0084
Tulane Cancer Center at Tulane University Hospital and Clinic New Orleans, Louisiana  70112
Josephine Ford Cancer Center at Henry Ford Hospital Detroit, Michigan  48202
Herbert Irving Comprehensive Cancer Center at Columbia University New York, New York  10032
Blumenthal Cancer Center at Carolinas Medical Center Charlotte, North Carolina  28232-2861
SUNY Downstate Medical Center Brooklyn, New York  11203
Loma Linda University Cancer Institute at Loma Linda University Medical Center Loma Linda, California  92354
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital Long Beach, California  90801
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Savannah, Georgia  31403-3089
Blank Children's Hospital Des Moines, Iowa  50309
Breslin Cancer Center at Ingham Regional Medical Center Lansing, Michigan  48910
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio  45229-3039
Legacy Emanuel Hospital and Health Center & Children's Hospital Portland, Oregon  97227
Hollings Cancer Center at Medical University of South Carolina Charleston, South Carolina  29425
Massey Cancer Center at Virginia Commonwealth University Richmond, Virginia  23298-0037
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division Charleston, West Virginia  25302
CCOP - Marshfield Clinic Research Foundation Marshfield, Wisconsin  54449
St. Mary's - Duluth Clinic Cancer Center Duluth, Minnesota  55805
James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642
Vermont Cancer Center at University of Vermont Burlington, Vermont  05405-0075
Group Health Central Hospital Seattle, Washington  98104
Lombardi Cancer Center at Georgetown University Medical Center Washington, District of Columbia  20007
Greenebaum Cancer Center at University of Maryland Medical Center Baltimore, Maryland  21201
UNMC Eppley Cancer Center at the University of Nebraska Medical Center Omaha, Nebraska  68198-7680
New York Weill Cornell Cancer Center at Cornell University New York, New York  10021
Lucile Packard Children's Hospital at Stanford University Medical Center Palo Alto, California  95798
Alfred I. duPont Hospital for Children Wilmington, Delaware  19803
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus Atlanta, Georgia  30342
University of South Alabama Cancer Research Institute Mobile, Alabama  36604
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center Los Angeles, California  90048
Children's Hospital and Research Center at Oakland Oakland, California  94609-1809
Kaiser Permanente Medical Center - Sacramento Sacramento, California  95825
Children's Hospital and Health Center, San Diego San Diego, California  92123-4282
University of Connecticut Comprehensive Cancer Center at University of Connecticut Health Center Farmington, Connecticut  06360-7106
Shands Cancer Center at the University of Florida Health Science Center Gainesville, Florida  32610-0296
Jackson Memorial Hospital Miami, Florida  33136
St. Joseph's Children's Hospital Tampa, Florida  33677-4227
MBCCOP-Medical College of Georgia Cancer Center Augusta, Georgia  30912-4000
Mountain States Tumor Institute - Boise Boise, Idaho  83712
University of Illinois Medical Center Chicago, Illinois  60612
Riley Children Cancer Center at Riley Hospital for Children Indianapolis, Indiana  46202-5225
Baystate Regional Cancer Program at Baystate Medical Center Springfield, Massachusetts  01107
William Beaumont Hospital - Royal Oak Royal Oak, Michigan  48073-6769
Children's Hospitals and Clinics - Minnesota Saint Paul, Minnesota  55102
Cancer Center at Hackensack University Medical Center Hackensack, New Jersey  07601
Cancer Institute of New Jersey at Robert Wood Johnson University Hospital New Brunswick, New Jersey  08903
Valerie Fund Children's Center at Atlantic Health Summit, New Jersey  07901
Comprehensive Cancer Center at Maimonides Medical Center Brooklyn, New York  11219
University Hospital at State University of New York - Upstate Medical University Syracuse, New York  13210
Mission Hospitals Asheville, North Carolina  28801
Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina Greenville, North Carolina  27858-4354
Dakota Cancer Institute at Innovis Health - Dakota Clinic Fargo, North Dakota  58103-4940
Children's Hospital at Oklahoma University Medical Center Oklahoma City, Oklahoma  73104
Doernbecher Children's Hospital at Oregon Health & Science University Portland, Oregon  97239-3098
Sioux Valley Hospital at University of South Dakota Medical Center Sioux Falls, South Dakota  57117-5039
East Tennessee State University Cancer Center at Johnson City Medical Center Johnson City, Tennessee  37604
Vanderbilt Children's Hospital Nashville, Tennessee  37232-6310
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas, Texas  75390-9063
Methodist Cancer Center at Methodist Specialty and Transplant Hospital San Antonio, Texas  78229-3902
MBCCOP - South Texas Pediatrics San Antonio, Texas  78229-3900
Center for Cancer Prevention and Care at Scott and White Clinic Temple, Texas  76508
Mary Bridge Children's Hospital and Health Center Tacoma, Washington  98415-0299
Cabell Huntington Hospital Huntington, West Virginia  25701