38
Participants
Start Date
April 30, 2004
Primary Completion Date
April 30, 2008
Study Completion Date
December 31, 2013
celecoxib
Given orally, Celecoxib 250 mg/m2 PO BID (500mg/m2/day) from Day 1 of Cycle 1 through Day 21 of Cycle 14. The dose should be rounded off to the nearest 100 mg. If PK studies are being done, Celecoxib should be given 24 hours prior to the other drugs for Cycle 1 only. \[Celecoxib may be interrupted for up to 7 days around the time of surgical procedures.\] .
cyclophosphamide
Given IV, 1200 mg/m2 IV infusion over 1 hour with MESNA uroprotection, on Day 1. For children \< 1 year treat with 50% doses calculated on a m2 basis. If tolerated (no delay in administration of the next cycle due to delayed count recovery or delayed resolution of other toxicities and no serious toxicities), consider increasing to 75% and then to 100% of the calculated full dose.
doxorubicin hydrochloride
Given IV, Doxorubicin 75 mg/ m2 /course continuous IV infusion over 48 hours, beginning Day 1. Note: The total doxorubicin dose per cycle is 75 mg/ m2, which will be given as 37.5 mg/m2/day x 2 days. Doxorubicin may be given as a continuous infusion or brief infusion.
etoposide
Given IV, Vincristine 2 mg/m2 IV push, on Day 1. Maximum dose 2 mg. For children \< 1 year treat with 50% doses calculated on a m2 basis. If tolerated (no delay in administration of the next cycle due to delayed count recovery or delayed resolution of other toxicities and no serious toxicities), consider increasing to 75% and then to 100% of the calculated full dose.
ifosfamide
Given IV,Ifosfamide 1800 mg/m2 /day IV infusion over 1 hour, Days 1-5 of each cycle. (9,000 mg/m2 max total dose per cycle). Prehydrate for 6 hours, 1,000 ml/m2 total volume (165 ml/m2/hour for 6 hours). For children \< 1 year treat with 50% doses calculated on a m2 basis. If tolerated (no delay in administration of the next cycle due to delayed count recovery or delayed resolution of other toxicities and no serious toxicities), consider increasing to 75% and then to 100% of the calculated full dose.
vinblastine sulfate
Given IV, Vinblastine 1 mg/m2/d IV push three times per week beginning Day 1 of Cycle 1 and continuing through Day 21 of Cycle 14. In weeks during which vincristine is given, hold one dose of vinblastine and administer only 2 doses of vinblastine during that week. If vinblastine is due the same day as vincristine, hold that dose of vinblastine. \[Vinblastine may be interrupted for up to 7 days around the time of surgical procedures.\]
vincristine sulfate
Given IV, Vincristine 2 mg/m2 IV push, on Day 1. Maximum dose 2 mg. For children \< 1 year treat with 50% doses calculated on a m2 basis. If tolerated (no delay in administration of the next cycle due to delayed count recovery or delayed resolution of other toxicities and no serious toxicities), consider increasing to 75% and then to 100% of the calculated full dose.
conventional surgery
Patients who respond to induction chemotherapy undergo surgery on week 13. Patients who have inadequate margins after surgery undergo radiotherapy beginning on week 15. (see Detailed Description for frequency of administration and groups evaluated)
radiation therapy
Patients with unresectable lesions undergo radiotherapy 5 days a week for approximately 6 weeks beginning on week 13. (see Detailed Description for frequency of administration and groups evaluated)
MESNA
The total daily MESNA dose is equal to at least 60% of the daily cyclophosphamide or ifosfamide dose, or by continuous infusion of the 60% dose. MESNA continuous infusion should be started at the same time as the cyclophosphamide/ifosfamide and be completed no sooner than 8 hours after the end of the cyclophosphamide or ifosfamide infusion. The oral dose of MESNA is 2x the IV dose. Patients able to tolerate oral MESNA may receive the final dose by mouth at 40% of the oxazaphosphorine (cyclophosphamide or ifosfamide) dose. The dose should be given two hours earlier than the IV dose would be given. Additionally, if the patient vomits within two hours after the oral dose, the dose should be repeated or IV MESNA given.
Filgrastim
G-CSF (Filgrastim) 5 micrograms/kg/day subcutaneously beginning 24 to 48 hours after the last dose of chemotherapy, and continuing until the absolute neutrophil count is 2,000/µL or greater after nadir.
Westmead Institute for Cancer Research at Westmead Hospital, Westmead
Herbert Irving Comprehensive Cancer Center at Columbia University, New York
Albert Einstein Cancer Center at Albert Einstein College of Medicine, The Bronx
New York Medical College, Valhalla
SUNY Upstate Medical University Hospital, Syracuse
James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester
Alfred I. duPont Hospital for Children, Wilmington
INOVA Fairfax Hospital, Fairfax
Carilion Cancer Center of Western Virginia, Roanoke
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division, Charleston
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital, Huntington
Palmetto Health South Carolina Cancer Center, Columbia
Hollings Cancer Center at Medical University of South Carolina, Charleston
Greenville Hospital System Cancer Center, Greenville
Winship Cancer Institute of Emory University, Atlanta
Nemours Children's Clinic, Jacksonville
Sacred Heart Cancer Center at Sacred Heart Hospital, Pensacola
Nemours Children's Clinic - Orlando, Orlando
University of Miami Sylvester Comprehensive Cancer Center, Miami
Kaplan Cancer Center at St. Mary's Medical Center, West Palm Beach
St. Joseph's Cancer Institute at St. Joseph's Hospital, Tampa
All Children's Hospital, St. Petersburg
Lee Cancer Care of Lee Memorial Health System, Fort Myers
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham
East Tennessee Children's Hospital, Knoxville
Kosair Children's Hospital, Louisville
Medical University of Ohio Cancer Center, Toledo
Tod Children's Hospital - Forum Health, Youngstown
St. Vincent Indianapolis Hospital, Indianapolis
Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods
Hurley Medical Center, Flint
Midwest Children's Cancer Center, Milwaukee
Marshfield Clinic - Marshfield Center, Marshfield
Children's Hospitals and Clinics of Minneapolis, Minneapolis
University of Minnesota Medical Center & Children's Hospital - Fairview, Minneapolis
Mayo Clinic Cancer Center, Rochester
Siteman Cancer Center at Barnes-Jewish Hospital, St Louis
Children's Mercy Hospital, Kansas City
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock
OU Cancer Institute, Oklahoma City
Medical City Dallas Hospital, Dallas
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas
CCOP - Scott and White Hospital, Temple
Texas Tech University Health Sciences Center School of Medicine - Amarillo, Amarillo
Childrens Hospital Los Angeles, Los Angeles
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital, Long Beach
Loma Linda University Cancer Institute at Loma Linda University Medical Center, Loma Linda
University of California Davis Cancer Center, Sacramento
Legacy Emanuel Hospital and Health Center & Children's Hospital, Portland
Phoenix Children's Hospital, Phoenix
Southern California Permanente Medical Group, Downey
Children's Hospital Central California, Madera
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center, Farmington
Florida Hospital Cancer Institute at Florida Hospital Orlando, Orlando
MBCCOP - Medical College of Georgia Cancer Center, Augusta
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah
Southern Illinois University School of Medicine, Springfield
Indiana University Cancer Center, Indianapolis
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City
Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington
CancerCare of Maine at Eastern Maine Medial Center, Bangor
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston
C.S. Mott Children's Hospital at University of Michigan, Ann Arbor
Barbara Ann Karmanos Cancer Institute, Detroit
Spectrum Health Hospital - Butterworth Campus, Grand Rapids
University of Mississippi Medical Center, Jackson
Sunrise Hospital and Medical Center, Las Vegas
Hackensack University Medical Center Cancer Center, Hackensack
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick
Roswell Park Cancer Institute, Buffalo
Blumenthal Cancer Center at Carolinas Medical Center, Charlotte
Presbyterian Cancer Center at Presbyterian Hospital, Charlotte
Children's Hospital Medical Center of Akron, Akron
Rainbow Babies and Children's Hospital, Cleveland
Cleveland Clinic Taussig Cancer Center, Cleveland
Columbus Children's Hospital, Columbus
Children's Medical Center - Dayton, Dayton
Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey
St. Christopher's Hospital for Children, Philadelphia
Vanderbilt-Ingram Cancer Center, Nashville
Cook Children's Medical Center - Fort Worth, Fort Worth
Baylor University Medical Center - Houston, Houston
Methodist Children's Hospital of South Texas, San Antonio
Primary Children's Medical Center, Salt Lake City
Children's Hospital of The King's Daughters, Norfolk
Virginia Commonwealth University Massey Cancer Center, Richmond
Providence Cancer Center at Sacred Heart Medical Center, Spokane
St. Vincent Hospital Regional Cancer Center, Green Bay
University of Alberta Hospital, Edmonton
Children's & Women's Hospital of British Columbia, Vancouver
CancerCare Manitoba, Winnipeg
IWK Health Centre, Halifax
McMaster Children's Hospital at Hamilton Health Sciences, Hamilton
Cancer Centre of Southeastern Ontario at Kingston General Hospital, Kingston
Children's Hospital of Eastern Ontario, Ottawa
Hospital for Sick Children, Toronto
Montreal Children's Hospital at McGill University Health Center, Montreal
Hopital Sainte Justine, Montreal
Saskatoon Cancer Centre at the University of Saskatchewan, Saskatoon
Centre Hospitalier Universitaire de Quebec, Québec
San Jorge Children's Hospital, Santurce
National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK