Sarcoma
Conditions
Keywords
recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor
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.
Interventions
Given IV
Sponsors
Study design
Eligibility
Inclusion 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Australia, Canada, Puerto Rico, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cytarbine Cytarabine IV every 12 hours days 1-5 of 21 day cycle. Response evaluation after 6 cycles of therapy. | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Lack of Efficacy | 7 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Cytarbine |
|---|---|
| Age, Categorical <=18 years | 4 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment Canada | 2 participants |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 10 / 10 |
| serious Total, serious adverse events | 2 / 10 |
Outcome results
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.
Time frame: the first six cycles of study chemotherapy (126 days)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cytarabine | Response | Non Responder | 10 participants |
| Cytarabine | Response | Responder | 0 participants |