Cytarabine in Treating Young Patients With Recurrent or Refractory Ewing's Sarcoma
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Intermediate-Dose Cytarabine to Modulate EWS/FLI for Children and Young Adults With Recurrent or Refractory Ewing Sarcoma|
- Response [ Time Frame: the first six cycles of study chemotherapy (126 days) ] [ Designated as safety issue: No ]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.
|Study Start Date:||May 2007|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
Cytarabine IV every 12 hours days 1-5 of 21 day cycle. Response evaluation after 6 cycles of therapy.
- 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.
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|Study Chair:||Kimberly Stegmaier, MD||Dana-Farber Cancer Institute|
|Principal Investigator:||Holcombe E. Grier, MD||Dana-Farber Cancer Institute|