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

Phase 2

Completed

• Conditions: Sarcoma
• Interventions: Drug: cytarabine

• 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.

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-05-03
• Study First Submitted QC: 2007-05-03
• Study First Posted: 2007-05-07
• Primary Completion: 2008-08
• Results First Submitted: 2013-08-29
• Results First Submitted QC: 2013-08-29
• Results First Posted: 2013-11-01
• Study Completion: 2013-12
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-09
• Last Update Posted: 2014-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

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.

Trial Locations

Locations (73)

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, District of Columbia, United States

Lee Cancer Care of Lee Memorial Health System; 🇺🇸 Fort Myers, Florida, United States

Scroll for more (63 remaining)