Cytarabine in Treating Young Patients With Recurrent or Refractory Ewing's Sarcoma
NCT ID: NCT00470275
Last Updated: 2014-10-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
10 participants
INTERVENTIONAL
2007-05-31
2013-12-31
Brief Summary
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PURPOSE: This phase II trial is studying how well cytarabine works in treating young patients with recurrent or refractory Ewing's sarcoma.
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cytarbine
Cytarabine IV every 12 hours days 1-5 of 21 day cycle. Response evaluation after 6 cycles of therapy.
cytarabine
Given IV
Interventions
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cytarabine
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No disease limited to bone
PATIENT CHARACTERISTICS:
* Karnofsky performance status (PS) 50-100% (for patients \> 16 years of age) OR Lansky PS 50-100% (for patients ≤ 16 years of age)
* Life expectancy ≥ 8 weeks
* ANC ≥ 750/mm\^3
* Platelet count ≥ 75,000/mm\^3 (50,000/mm\^3 if documented bone marrow metastatic disease) (transfusion independent)
* Hemoglobin ≥ 8.0 g/dL (red blood cell transfusions allowed)
* Bilirubin ≤ 1.5 times upper limit of normal (ULN) for age and \< 2.0 mg/dL
* ALT ≤ 2.5 times ULN
* Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR creatinine meeting the following criteria:
* ≤ 0.4 mg/dL (1 month to \< 6 months of age)
* ≤ 0.5 mg/dL (6 months to \< 1 year of age)
* ≤ 0.6 mg/dL (1 to \< 2 years of age)
* ≤ 0.8 mg/dL (2 to \< 6 years of age)
* ≤ 1.0 mg/dL (6 to \< 10 years of age)
* ≤ 1.2 mg/dL (10 to \< 13 years of age)
* ≤ 1.4 mg/dL (≥ 13 years of age) (female)
* ≤ 1.5 mg/dL (13 to \< 16 years of age) (male)
* ≤ 1.7 mg/dL (≥ 16 years of age) (male)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No uncontrolled infection, including systemic fungal infections requiring ongoing antifungal therapy
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Recovered from all prior tumor-directed therapy
* At least 7 days since prior biologic therapy or immunotherapy
* At least 1 week since prior hematopoietic growth factors (2 weeks for pegfilgrastim)
* At least 2 weeks since prior myelosuppressive chemotherapy
* At least 2 weeks since prior local palliative (small-port) radiotherapy
* At least 6 weeks since prior substantial bone marrow radiotherapy
* At least 6 months since prior radiotherapy to ≥ 50% of the pelvis
* At least 6 months since prior autologous stem cell transplantation
* No prior allogeneic stem cell transplantation
* No prior cytarabine
* No other concurrent investigational agents, including chemotherapy, immunotherapy, or biologic therapy
* No other concurrent anticancer chemotherapy or immunomodulating agents
* Concurrent corticosteroids allowed
* No concurrent intrathecal chemotherapy
* Concurrent radiotherapy to localized painful lesions allowed provided at least one measurable lesion is not irradiated (no irradiated lesion may be used to assess tumor response)
30 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Kimberly Stegmaier, MD
Role: STUDY_CHAIR
Dana-Farber Cancer Institute
Holcombe E. Grier, MD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
Birmingham, Alabama, United States
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Southern California Permanente Medical Group
Downey, California, United States
Children's Hospital Central California
Madera, California, United States
Children's Hospital of Orange County
Orange, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
Farmington, Connecticut, United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Lee Cancer Care of Lee Memorial Health System
Fort Myers, Florida, United States
All Children's Hospital
St. Petersburg, Florida, United States
St. Joseph's Cancer Institute at St. Joseph's Hospital
Tampa, Florida, United States
Kaplan Cancer Center at St. Mary's Medical Center
West Palm Beach, Florida, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States
Children's Memorial Hospital - Chicago
Chicago, Illinois, United States
Simmons Cooper Cancer Institute
Springfield, Illinois, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Lucille P. Markey Cancer Center at University of Kentucky
Lexington, Kentucky, United States
Tulane Cancer Center Office of Clinical Research
Alexandria, Louisiana, United States
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States
C.S. Mott Children's Hospital at University of Michigan Medical Center
Ann Arbor, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Butterworth Hospital at Spectrum Health
Grand Rapids, Michigan, United States
University of Mississippi Cancer Clinic
Jackson, Mississippi, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - Saint Louis
St Louis, Missouri, United States
Sunrise Hospital and Medical Center
Las Vegas, Nevada, United States
Hackensack University Medical Center Cancer Center
Hackensack, New Jersey, United States
Overlook Hospital
Morristown, New Jersey, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 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
Stony Brook University Cancer Center
Stony Brook, New York, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States
Akron Children's Hospital
Akron, Ohio, United States
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Columbus Children's Hospital
Columbus, Ohio, United States
Children's Medical Center - Dayton
Dayton, Ohio, United States
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States
Legacy Emanuel Hospital and Health Center and Children's Hospital
Portland, Oregon, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Rhode Island Hospital Comprehensive Cancer Center
Providence, Rhode Island, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States
Palmetto Health South Carolina Cancer Center
Columbia, South Carolina, United States
Greenville Hospital Cancer Center
Greenville, South Carolina, United States
East Tennessee Children's Hospital
Knoxville, Tennessee, United States
Texas Tech University Health Sciences Center School of Medicine - Amarillo
Amarillo, Texas, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, United States
Baylor University Medical Center - Houston
Houston, Texas, 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
Primary Children's Medical Center
Salt Lake City, Utah, United States
Children's Hospital of The King's Daughters
Norfolk, Virginia, United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States
West Virginia University Health Sciences Center - Charleston
Charleston, West Virginia, United States
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States
Princess Margaret Hospital for Children
Perth, Western Australia, Australia
University of Alberta Hospital
Edmonton, Alberta, Canada
IWK Health Centre
Halifax, Nova Scotia, Canada
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
Montreal Children's Hospital at McGill University Health Center
Montreal, Quebec, Canada
Hopital Sainte Justine
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec
Québec, , Canada
San Jorge Children's Hospital
Santurce, , Puerto Rico
Countries
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References
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DuBois SG, Krailo MD, Lessnick SL, Smith R, Chen Z, Marina N, Grier HE, Stegmaier K; Children's Oncology Group. Phase II study of intermediate-dose cytarabine in patients with relapsed or refractory Ewing sarcoma: a report from the Children's Oncology Group. Pediatr Blood Cancer. 2009 Mar;52(3):324-7. doi: 10.1002/pbc.21822.
Other Identifiers
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CDR0000542650
Identifier Type: OTHER
Identifier Source: secondary_id
COG-AEWS0621
Identifier Type: OTHER
Identifier Source: secondary_id
AEWS0621
Identifier Type: -
Identifier Source: org_study_id
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