NCT00470275

Cytarabine in Treating Young Patients With Recurrent or Refractory Ewing's Sarcoma

Phase II Trial of Intermediate-Dose Cytarabine to Modulate EWS/FLI for Children and Young Adults With Recurrent or Refractory Ewing Sarcoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sarcoma

Interventions

Type	Name	Description
DRUG	cytarabine	Given IV

Timeline

• Start date: 2007-05-01
• Primary completion: 2008-08-01
• Completion: 2013-12-01
• First posted: 2007-05-07
• Last updated: 2014-10-20
• Results posted: 2013-11-01

Locations

73 sites across 4 countries: United States, Australia, Canada, Puerto Rico