Vinblastine, Celecoxib, and Combination Chemotherapy in Treating Patients With Newly-Diagnosed Metastatic Ewing's Sarcoma Family of Tumors
Sarcoma
About this trial
This is an interventional treatment trial for Sarcoma focused on measuring metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
Eligibility Criteria
DISEASE CHARACTERISTICS: Newly diagnosed Ewing's sarcoma family of tumors of the bone or soft tissues Paraspinal tumors of extra-dural origin and Askin's tumor of the chest wall are eligible Metastatic disease, defined by the following criteria: Lesions are discontinuous from the primary tumor, are not regional lymph nodes, and do not share a body cavity with the primary tumor A single pulmonary or pleural nodule greater than 1 cm OR multiple nodules greater than 0.5 cm are considered evidence of pulmonary or pleural metastases (unless there is another clear medical explanation for these lesions) Contralateral pleural effusions are considered metastatic disease No CNS involvement PATIENT CHARACTERISTICS: Age 50 and under (at diagnosis) Performance status Lansky 50-100% (under 17 years of age) Karnofsky 50-100% (age 17 and over) Patients whose performance status is affected by a pathological fracture are allowed provided they are able to undergo treatment Life expectancy Not specified Hematopoietic Not specified Hepatic Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST or ALT less than 5 times ULN Renal Creatinine adjusted according to age as follows*: No greater than 0.4 mg/dL (≤ 5 months) No greater than 0.5 mg/dL (6 months -11 months) No greater than 0.6 mg/dL (1 year-23 months) No greater than 0.8 mg/dL (2 years-5 years) No greater than 1.0 mg/dL (6 years-9 years) No greater than 1.2 mg/dL (10 years-12 years) No greater than 1.4 mg/dL (13 years and over [female]) No greater than 1.5 mg/dL (13 years to 15 years [male]) No greater than 1.7 mg/dL (16 years and over [male]) OR Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min* NOTE: *Unless these values are related to renal insufficiency secondary to tumor involvement that is expected to improve once the tumor mass is smaller (e.g., pelvic mass causing obstructive hydronephrosis) Cardiovascular Shortening fraction at least 27% by echocardiogram OR Ejection fraction at least 50% by MUGA Other Not pregnant or nursing Fertile patients must use effective contraception Body surface area at least 0.4 m^2 No allergy to sulfa No aspirin hypersensitivity No asthma triad (asthma with nasal polyps, and urticaria) No other prior cancer, including nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy No prior bone marrow or stem cell transplantation Chemotherapy No prior chemotherapy Endocrine therapy Not specified Radiotherapy No prior radiotherapy Surgery Not specified Other No other concurrent nonsteroidal anti-inflammatory medications, including salicylates No concurrent dexrazoxane unless approved by the study investigator
Sites / Locations
- University of Alabama at Birmingham Comprehensive Cancer Center
- Phoenix Children's Hospital
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- Southern California Permanente Medical Group
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
- Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
- Childrens Hospital Los Angeles
- Children's Hospital Central California
- University of California Davis Cancer Center
- Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
- Alfred I. duPont Hospital for Children
- Lee Cancer Care of Lee Memorial Health System
- Nemours Children's Clinic
- University of Miami Sylvester Comprehensive Cancer Center
- Florida Hospital Cancer Institute at Florida Hospital Orlando
- Nemours Children's Clinic - Orlando
- Sacred Heart Cancer Center at Sacred Heart Hospital
- All Children's Hospital
- St. Joseph's Cancer Institute at St. Joseph's Hospital
- Kaplan Cancer Center at St. Mary's Medical Center
- Winship Cancer Institute of Emory University
- MBCCOP - Medical College of Georgia Cancer Center
- Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
- Southern Illinois University School of Medicine
- Indiana University Cancer Center
- St. Vincent Indianapolis Hospital
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
- Markey Cancer Center at University of Kentucky Chandler Medical Center
- Kosair Children's Hospital
- CancerCare of Maine at Eastern Maine Medial Center
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
- C.S. Mott Children's Hospital at University of Michigan
- Barbara Ann Karmanos Cancer Institute
- Hurley Medical Center
- Spectrum Health Hospital - Butterworth Campus
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- Children's Hospitals and Clinics of Minneapolis
- University of Minnesota Medical Center & Children's Hospital - Fairview
- Mayo Clinic Cancer Center
- University of Mississippi Medical Center
- Children's Mercy Hospital
- Siteman Cancer Center at Barnes-Jewish Hospital
- Sunrise Hospital and Medical Center
- Hackensack University Medical Center Cancer Center
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
- Roswell Park Cancer Institute
- Herbert Irving Comprehensive Cancer Center at Columbia University
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- SUNY Upstate Medical University Hospital
- New York Medical College
- Blumenthal Cancer Center at Carolinas Medical Center
- Presbyterian Cancer Center at Presbyterian Hospital
- Children's Hospital Medical Center of Akron
- Rainbow Babies and Children's Hospital
- Cleveland Clinic Taussig Cancer Center
- Columbus Children's Hospital
- Children's Medical Center - Dayton
- Medical University of Ohio Cancer Center
- Tod Children's Hospital - Forum Health
- OU Cancer Institute
- Legacy Emanuel Hospital and Health Center & Children's Hospital
- Penn State Cancer Institute at Milton S. Hershey Medical Center
- St. Christopher's Hospital for Children
- Hollings Cancer Center at Medical University of South Carolina
- Palmetto Health South Carolina Cancer Center
- Greenville Hospital System Cancer Center
- East Tennessee Children's Hospital
- Vanderbilt-Ingram Cancer Center
- Texas Tech University Health Sciences Center School of Medicine - Amarillo
- Medical City Dallas Hospital
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
- Cook Children's Medical Center - Fort Worth
- Baylor University Medical Center - Houston
- Methodist Children's Hospital of South Texas
- CCOP - Scott and White Hospital
- Primary Children's Medical Center
- INOVA Fairfax Hospital
- Children's Hospital of The King's Daughters
- Virginia Commonwealth University Massey Cancer Center
- Carilion Cancer Center of Western Virginia
- Providence Cancer Center at Sacred Heart Medical Center
- West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
- Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
- St. Vincent Hospital Regional Cancer Center
- Marshfield Clinic - Marshfield Center
- Midwest Children's Cancer Center
- Westmead Institute for Cancer Research at Westmead Hospital
- University of Alberta Hospital
- Children's & Women's Hospital of British Columbia
- CancerCare Manitoba
- IWK Health Centre
- McMaster Children's Hospital at Hamilton Health Sciences
- Cancer Centre of Southeastern Ontario at Kingston General Hospital
- Children's Hospital of Eastern Ontario
- Hospital for Sick Children
- Montreal Children's Hospital at McGill University Health Center
- Hopital Sainte Justine
- Saskatoon Cancer Centre at the University of Saskatchewan
- Centre Hospitalier Universitaire de Quebec
- San Jorge Children's Hospital
Arms of the Study
Arm 1
Experimental
Combination chemotherapy
Metastatic Ewing Sarcoma - 14-cycle study building on conventional tx (cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, ifosfamide, etoposide) and adding two antiangiogenic agents: the vinca alkaloid vinblastine and the cyclooxygenase-2 inhibitor celecoxib. Refer to the Interventions section for dosages, method of delivery and frequency of administration.