Clinical trial · Interventional
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
NCT00470275CI-TRIAL-00015861completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cytarabine | Drug | Cytarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cytarbine
- description
- Cytarabine IV every 12 hours days 1-5 of 21 day cycle. Response evaluation after 6 cycles of therapy.
- interventionNames
- Drug: cytarabine
Primary outcomes (1)
- measure
- Response
- timeFrame
- the first six cycles of study chemotherapy (126 days)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 30 Years
Show eligibility criteria text
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)
References
Publications (1)
- RESULTDuBois 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. PMID 18989890