The outcome of patients with metastatic Ewings Sarcoma is poor with current standard of care chemotherapy, with less than 30% survival. Based on recent encouraging pediatric literature we have designed this trial to improve the outcome of patients with metastatic Ewings sarcoma using Irinotecan and Temozolomide in addition to standard chemotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
50 mg/m2/day x 5 days
2 mg/m2 to a maximum of 2 mg
100 mg/m2/day x 5 days followed by 2 weeks treatment-free
Stanford University School of Medicine
Stanford, California, United States
Overall Response Rate (Partial and Complete Response)
Response was evaluated every 12 weeks during treatment. Subjects who discontinue treatment for reasons other than disease progression or initiation of new anticancer therapy (excluding radiation therapy and surgery) response evaluated every 6 months following the last dose of study drug. Scans should be obtained every 6 months for up to 2 years (24 months) or until progression of disease or initiation of new anticancer therapy. Complete response (CR) Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as a reference the baseline sum diameters.
Time frame: Up to 24 months
Progression-free Survival (PFS)
The intended outcome is a measure of whether participants are alive without disease progression 2 years (24 months) after treatment.
Time frame: 24 months
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Starting dose 75 mg/m2 to a maximum of 450mg/m2
1200 mg/m2
6 mg subcutaneous within 24 to 48 hours after each Regimen A cycle