Phase 2
N=10
Cytarabine in Treating Young Patients With Recurrent or Refractory Ewing's Sarcoma
Sarcoma
Bottom Line
View on ClinicalTrials.gov: NCT00470275 ↗Enrolled (actual)
10
Serious AEs
20.0%
Results posted
Nov 2013
Primary outcome: Primary: Response — 10; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- cytarabine (Drug)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- Children's Oncology Group
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response |
10; 0 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT00470275). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.