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
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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Alberto S. Pappo, MD
Study Chair
Texas Children's Cancer Center
United States: Federal Government
CDR0000067154
NCT00003955
March 2001
Name | Location |
---|---|
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 |
Eastern Maine Medical Center | Bangor, Maine 04401 |
CCOP - Oklahoma | Tulsa, Oklahoma 74136 |
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 |
Children's Mercy Hospital | Kansas City, Missouri 64108 |
St. Joseph's Hospital and Medical Center | Paterson, New Jersey 07503 |
Children's Hospital of Columbus | Columbus, Ohio 43205-2696 |
Children's Hospital of Pittsburgh | Pittsburgh, Pennsylvania 15213 |
Children's Hospital and Regional Medical Center - Seattle | Seattle, Washington 98105 |
Rebecca and John Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
University of California Davis Cancer Center | Sacramento, California 95817 |
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego | San Diego, California 92120 |
Kaiser Permanente Medical Center - Santa Clara | Santa Clara, California 95051-5386 |
Broward General Medical Center | Fort Lauderdale, Florida 33316 |
Children's Hospital of Southwest Florida | Fort Myers, Florida 33908 |
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 |
Children's Hospital of Greenville Hospital System | Greenville, South Carolina 29605 |
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 |
Southern Illinois University School of Medicine | Springfield, Illinois 62794-9658 |
Kosair Children's Hospital | Louisville, Kentucky 40202-3830 |
Spectrum Health and DeVos Children's Hospital | Grand Rapids, Michigan 49503 |
CCOP - Beaumont | Royal Oak, Michigan 48073-6769 |
Children's Hospitals and Clinics - Minneapolis | Minneapolis, Minnesota 55404 |
St. Louis Children's Hospital | Saint Louis, Missouri 63110 |
Children's Hospital of Omaha | Omaha, Nebraska 68114 |
Sunrise Hospital and Medical Center | Las Vegas, Nevada 89109-2306 |
Brookdale University Hospital and Medical Center | Brooklyn, New York 11212 |
Brooklyn Hospital Center | Brooklyn, New York 11201 |
Children's Hospital Medical Center of Akron | Akron, Ohio 44308 |
Children's Medical Center - Dayton | Dayton, Ohio 45404 |
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 |