Cytarabine in Treating Young Patients With Recurrent or Refractory Ewing's Sarcoma
- Registration Number
- NCT00470275
- Lead Sponsor
- Children's Oncology Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as cytarabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well cytarabine works in treating young patients with recurrent or refractory Ewing's sarcoma.
- Detailed Description
OBJECTIVES:
* Determine the response rate in younger patients with recurrent or refractory Ewing's sarcoma treated with cytarabine.
OUTLINE: This is a multicenter study.
Patients receive cytarabine IV over 2 hours twice daily on days 1-5. Treatment repeats every 21 days for up to 11 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cytarbine cytarabine Cytarabine IV every 12 hours days 1-5 of 21 day cycle. Response evaluation after 6 cycles of therapy.
- Primary Outcome Measures
Name Time Method Response the first six cycles of study chemotherapy (126 days) Any patient who is enrolled and receives at least one dose of cytarabine will be considered evaluable for response if (1) the patient demonstrates progressive disease while on protocol therapy or (2) the patient is observed on protocol therapy for at least one cycle. Patients who achieve a complete or partial response according to the RECIST (Response Evaluation Criteria In Solid Tumors) criteria will be considered responders for the study design. All other patients who are evaluable for response will be considered non-responders for the study.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (73)
Columbus Children's Hospital
🇺🇸Columbus, Ohio, United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Tulane Cancer Center Office of Clinical Research
🇺🇸Alexandria, Louisiana, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
West Virginia University Health Sciences Center - Charleston
🇺🇸Charleston, West Virginia, United States
Hopital Sainte Justine
🇨🇦Montreal, Quebec, Canada
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
Blumenthal Cancer Center at Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Rainbow Babies and Children's Hospital
🇺🇸Cleveland, Ohio, United States
Rhode Island Hospital Comprehensive Cancer Center
🇺🇸Providence, Rhode Island, United States
Arizona Cancer Center at University of Arizona Health Sciences Center
🇺🇸Tucson, Arizona, United States
Lucille P. Markey Cancer Center at University of Kentucky
🇺🇸Lexington, Kentucky, United States
University of Mississippi Cancer Clinic
🇺🇸Jackson, Mississippi, United States
Lee Cancer Care of Lee Memorial Health System
🇺🇸Fort Myers, Florida, United States
Southern California Permanente Medical Group
🇺🇸Downey, California, United States
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States
Palmetto Health South Carolina Cancer Center
🇺🇸Columbia, South Carolina, United States
Children's Hospital Central California
🇺🇸Madera, California, United States
Baylor University Medical Center - Houston
🇺🇸Houston, Texas, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Akron Children's Hospital
🇺🇸Akron, Ohio, United States
Cook Children's Medical Center - Fort Worth
🇺🇸Fort Worth, Texas, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
🇺🇸Baltimore, Maryland, United States
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - Saint Louis
🇺🇸St. Louis, Missouri, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
🇺🇸Dallas, Texas, United States
Children's Memorial Hospital - Chicago
🇺🇸Chicago, Illinois, United States
NYU Cancer Institute at New York University Medical Center
🇺🇸New York, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
🇺🇸New York, New York, United States
All Children's Hospital
🇺🇸St. Petersburg, Florida, United States
C.S. Mott Children's Hospital at University of Michigan Medical Center
🇺🇸Ann Arbor, Michigan, United States
Children's Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
Stony Brook University Cancer Center
🇺🇸Stony Brook, New York, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
East Tennessee Children's Hospital
🇺🇸Knoxville, Tennessee, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Children's Hospital of The King's Daughters
🇺🇸Norfolk, Virginia, United States
IWK Health Centre
🇨🇦Halifax, Nova Scotia, Canada
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Centre Hospitalier Universitaire de Quebec
🇨🇦Quebec, Canada
San Jorge Children's Hospital
🇵🇷Santurce, Puerto Rico
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Indiana University Melvin and Bren Simon Cancer Center
🇺🇸Indianapolis, Indiana, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Sunrise Hospital and Medical Center
🇺🇸Las Vegas, Nevada, United States
M. D. Anderson Cancer Center at University of Texas
🇺🇸Houston, Texas, United States
Methodist Children's Hospital of South Texas
🇺🇸San Antonio, Texas, United States
Children's Hospital and Regional Medical Center - Seattle
🇺🇸Seattle, Washington, United States
Cancer Research Center of Hawaii
🇺🇸Honolulu, Hawaii, United States
Children's Hospital of Orange County
🇺🇸Orange, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
🇺🇸Birmingham, Alabama, United States
Oklahoma University Cancer Institute
🇺🇸Oklahoma City, Oklahoma, United States
St. Joseph's Cancer Institute at St. Joseph's Hospital
🇺🇸Tampa, Florida, United States
Legacy Emanuel Hospital and Health Center and Children's Hospital
🇺🇸Portland, Oregon, United States
Midwest Children's Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
University of New Mexico Cancer Center
🇺🇸Albuquerque, New Mexico, United States
Texas Tech University Health Sciences Center School of Medicine - Amarillo
🇺🇸Amarillo, Texas, United States
Marshfield Clinic - Marshfield Center
🇺🇸Marshfield, Wisconsin, United States
Kaplan Cancer Center at St. Mary's Medical Center
🇺🇸West Palm Beach, Florida, United States
Simmons Cooper Cancer Institute
🇺🇸Springfield, Illinois, United States
Butterworth Hospital at Spectrum Health
🇺🇸Grand Rapids, Michigan, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Overlook Hospital
🇺🇸Morristown, New Jersey, United States
Hackensack University Medical Center Cancer Center
🇺🇸Hackensack, New Jersey, United States
Greenville Hospital Cancer Center
🇺🇸Greenville, South Carolina, United States
Primary Children's Medical Center
🇺🇸Salt Lake City, Utah, United States
McMaster Children's Hospital at Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
Children's Hospital of Eastern Ontario
🇨🇦Ottawa, Ontario, Canada
Princess Margaret Hospital for Children
🇦🇺Perth, Western Australia, Australia
Montreal Children's Hospital at McGill University Health Center
🇨🇦Montreal, Quebec, Canada
Hollings Cancer Center at Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States