Clinical TrialID 7238

Vinblastine, Celecoxib, and Combination Chemotherapy in Treating Patients With Newly-Diagnosed Metastatic Ewing's Sarcoma Family of Tumors

NCT00061893

Sarcoma

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Record Fields

Scalar fields from the final clinical_trial record.

Clinical Trial Id
7238
Evidence Id
7238
Core Evidence Id
7238
Source Clinical Trial Id
7228
Herb2 Clinical Trial Id
HBCT007228
Nct Id
NCT00061893
Title
Vinblastine, Celecoxib, and Combination Chemotherapy in Treating Patients With Newly-Diagnosed Metastatic Ewing's Sarcoma Family of Tumors
Status
Completed
Phase
Phase 2
Study Result
Yes
Study Condition
Sarcoma
Study Type
Interventional
Study Design
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Intervention
DRUG: celecoxib|DRUG: cyclophosphamide|DRUG: doxorubicin hydrochloride|DRUG: etoposide|DRUG: ifosfamide|DRUG: vinblastine sulfate|DRUG: vincristine sulfate|PROCEDURE: conventional surgery|RADIATION: radiation therapy|DRUG: MESNA|DRUG: Filgrastim
Intervention Allocation
Intervention Model
Single_Group
Intervention Mask
Intervention Purpose
Treatment
Gender
All
Age
Child, Adult
Enrollment
38
Outcome Measure
Occurrence of Severe Toxicity, An incidence of severe toxicity is defined to be the occurrence of grade 3 or higher infection or grade 3 or higher sensory neuropathy during cycles 1-2 of protocol therapy. If 12 or more patients experience grade 3 or higher infection or five or more patients experience grade 3 or higher sensory neuropathy during cycles 1-2 of protocol therapy, the regimen will be flagged as being associated with an excessive rate of severe toxicity., The first two cycles (6 weeks) of protocol chemotherapy
Sponsor Collaborator
Children's Oncology Group|National Cancer Institute (NCI)
Funded By
NETWORK
Location
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, 35294, United States|Phoenix Children's Hospital, Phoenix, Arizona, 85016-7710, United States|Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, 72205, United States|Southern California Permanente Medical Group, Downey, California, 90242-2814, United States|Loma Linda University Cancer Institute at Loma Linda University Medical Center, Loma Linda, California, 92354, United States|Jonathan Jaques Children's Cancer Center at Miller Children's Hospital, Long Beach, California, 90801, United States|Childrens Hospital Los Angeles, Los Angeles, California, 90027, United States|Children's Hospital Central California, Madera, California, 93638-8762, United States|University of California Davis Cancer Center, Sacramento, California, 95817, United States|Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center, Farmington, Connecticut, 06360-2875, United States|Alfred I. duPont Hospital for Children, Wilmington, Delaware, 19899, United States|Lee Cancer Care of Lee Memorial Health System, Fort Myers, Florida, 33901, United States|Nemours Children's Clinic, Jacksonville, Florida, 32207, United States|University of Miami Sylvester Comprehensive Cancer Center, Miami, Florida, 33136, United States|Florida Hospital Cancer Institute at Florida Hospital Orlando, Orlando, Florida, 32803-1273, United States|Nemours Children's Clinic - Orlando, Orlando, Florida, 32806, United States|Sacred Heart Cancer Center at Sacred Heart Hospital, Pensacola, Florida, 32504, United States|All Children's Hospital, Saint Petersburg, Florida, 33701, United States|St. Joseph's Cancer Institute at St. Joseph's Hospital, Tampa, Florida, 33607, United States|Kaplan Cancer Center at St. Mary's Medical Center, West Palm Beach, Florida, 33407, United States|Winship Cancer Institute of Emory University, Atlanta, Georgia, 30322, United States|MBCCOP - Medical College of Georgia Cancer Center, Augusta, Georgia, 30912-3730, United States|Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah, Georgia, 31403-3089, United States|Southern Illinois University School of Medicine, Springfield, Illinois, 62794-9620, United States|Indiana University Cancer Center, Indianapolis, Indiana, 46202-5289, United States|St. Vincent Indianapolis Hospital, Indianapolis, Indiana, 46260, United States|Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City, Kansas, 66160-7357, United States|Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington, Kentucky, 40536-0293, United States|Kosair Children's Hospital, Louisville, Kentucky, 40232, United States|CancerCare of Maine at Eastern Maine Medial Center, Bangor, Maine, 04401, United States|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, 02115, United States|C.S. Mott Children's Hospital at University of Michigan, Ann Arbor, Michigan, 48109-0238, United States|Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, 48201-1379, United States|Hurley Medical Center, Flint, Michigan, 48503, United States|Spectrum Health Hospital - Butterworth Campus, Grand Rapids, Michigan, 49503-2560, United States|Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan, 48236, United States|Children's Hospitals and Clinics of Minneapolis, Minneapolis, Minnesota, 55404, United States|University of Minnesota Medical Center & Children's Hospital - Fairview, Minneapolis, Minnesota, 55455, United States|Mayo Clinic Cancer Center, Rochester, Minnesota, 55905, United States|University of Mississippi Medical Center, Jackson, Mississippi, 39216-4505, United States|Children's Mercy Hospital, Kansas City, Missouri, 64108, United States|Siteman Cancer Center at Barnes-Jewish Hospital, Saint Louis, Missouri, 63110, United States|Sunrise Hospital and Medical Center, Las Vegas, Nevada, 89109-2306, United States|Hackensack University Medical Center Cancer Center, Hackensack, New Jersey, 07601, United States|Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey, 08903, United States|Albert Einstein Cancer Center at Albert Einstein College of Medicine, Bronx, New York, 10461, United States|Roswell Park Cancer Institute, Buffalo, New York, 14263-0001, United States|Herbert Irving Comprehensive Cancer Center at Columbia University, New York, New York, 10032, United States|James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, 14642, United States|SUNY Upstate Medical University Hospital, Syracuse, New York, 13210, United States|New York Medical College, Valhalla, New York, 10595, United States|Blumenthal Cancer Center at Carolinas Medical Center, Charlotte, North Carolina, 28232-2861, United States|Presbyterian Cancer Center at Presbyterian Hospital, Charlotte, North Carolina, 28233-3549, United States|Children's Hospital Medical Center of Akron, Akron, Ohio, 44308-1062, United States|Rainbow Babies and Children's Hospital, Cleveland, Ohio, 44106-5000, United States|Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, 44195-5217, United States|Columbus Children's Hospital, Columbus, Ohio, 43205-2696, United States|Children's Medical Center - Dayton, Dayton, Ohio, 45404-1815, United States|Medical University of Ohio Cancer Center, Toledo, Ohio, 43614, United States|Tod Children's Hospital - Forum Health, Youngstown, Ohio, 44501, United States|OU Cancer Institute, Oklahoma City, Oklahoma, 73104, United States|Legacy Emanuel Hospital and Health Center & Children's Hospital, Portland, Oregon, 97227, United States|Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania, 17033-0850, United States|St. Christopher's Hospital for Children, Philadelphia, Pennsylvania, 19134-1095, United States|Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina, 29425, United States|Palmetto Health South Carolina Cancer Center, Columbia, South Carolina, 29203, United States|Greenville Hospital System Cancer Center, Greenville, South Carolina, 29605, United States|East Tennessee Children's Hospital, Knoxville, Tennessee, 37916, United States|Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, 37232-6310, United States|Texas Tech University Health Sciences Center School of Medicine - Amarillo, Amarillo, Texas, 79106, United States|Medical City Dallas Hospital, Dallas, Texas, 75230, United States|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas, 75390, United States|Cook Children's Medical Center - Fort Worth, Fort Worth, Texas, 76104-9958, United States|Baylor University Medical Center - Houston, Houston, Texas, 77030-2399, United States|Methodist Children's Hospital of South Texas, San Antonio, Texas, 78229-3993, United States|CCOP - Scott and White Hospital, Temple, Texas, 76508, United States|Primary Children's Medical Center, Salt Lake City, Utah, 84113-1100, United States|INOVA Fairfax Hospital, Fairfax, Virginia, 22031, United States|Children's Hospital of The King's Daughters, Norfolk, Virginia, 23507-1971, United States|Virginia Commonwealth University Massey Cancer Center, Richmond, Virginia, 23298-0037, United States|Carilion Cancer Center of Western Virginia, Roanoke, Virginia, 24029, United States|Providence Cancer Center at Sacred Heart Medical Center, Spokane, Washington, 99220-2555, United States|West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division, Charleston, West Virginia, 25302, United States|Edwards Comprehensive Cancer Center at Cabell Huntington Hospital, Huntington, West Virginia, 25701, United States|St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin, 54307-3508, United States|Marshfield Clinic - Marshfield Center, Marshfield, Wisconsin, 54449, United States|Midwest Children's Cancer Center, Milwaukee, Wisconsin, 53226, United States|Westmead Institute for Cancer Research at Westmead Hospital, Westmead, New South Wales, 2145, Australia|University of Alberta Hospital, Edmonton, Alberta, T6G 1Z2, Canada|Children's & Women's Hospital of British Columbia, Vancouver, British Columbia, V6H 3V4, Canada|CancerCare Manitoba, Winnipeg, Manitoba, R3E 0V9, Canada|IWK Health Centre, Halifax, Nova Scotia, B3K 6R8, Canada|McMaster Children's Hospital at Hamilton Health Sciences, Hamilton, Ontario, L8N 3Z5, Canada|Cancer Centre of Southeastern Ontario at Kingston General Hospital, Kingston, Ontario, K7L 3N6, Canada|Children's Hospital of Eastern Ontario, Ottawa, Ontario, K1H 8L1, Canada|Hospital for Sick Children, Toronto, Ontario, M5G 1X8, Canada|Montreal Children's Hospital at McGill University Health Center, Montreal, Quebec, H3H 1P3, Canada|Hopital Sainte Justine, Montreal, Quebec, H3T 1C5, Canada|Saskatoon Cancer Centre at the University of Saskatchewan, Saskatoon, Saskatchewan, S7N 4H4, Canada|Centre Hospitalier Universitaire de Quebec, Quebec, G1V 4G2, Canada|San Jorge Children's Hospital, Santurce, 00912, Puerto Rico
Other Id
AEWS02P1|CDR0000302409
Start Date
2004-04
Primary Completion Date
2008-04
Completion Date
2013-12
First Posted
2003-06-06
Results First Posted
2013-03-12
Last Update Posted
2019-02-15
Study Document
Study Url
https://clinicaltrials.gov/study/NCT00061893
Title Cn
Title En
Vinblastine, Celecoxib, and Combination Chemotherapy in Treating Patients With Newly-Diagnosed Metastatic Ewing's Sarcoma Family of Tumors
Bilingual Status
semi_complete