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

Study Overview
=================
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.

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

Conditions
-----------------
Sarcoma

Intervention / Treatment
-----------------
* Drug: cytarabine


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically confirmed Ewing's sarcoma or primitive neuroectodermal tumor (PNET) Disease that has recurred or not responded despite prior therapy Has declined enrollment on or is not eligible for clinical trial COG-AEWS0521 Must have at least one site of measurable disease involving lung or soft tissue as documented by CT scan and/or MRI 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)

Ages Eligible for Study
-----------------
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cytarbine<br>Cytarabine IV every 12 hours days 1-5 of 21 day cycle. Response evaluation after 6 cycles of therapy. | Drug: cytarabine<br>* Given IV<br>* Other names: NSC #063878;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response | 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. | the first six cycles of study chemotherapy (126 days) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor