Cyclophosphamide, Doxorubicin, Vincristine w/ Irinotecan and Temozolomide in Ewings Sarcoma (NCT01313884) | Clinical Trial Compass
TerminatedPhase 2
Cyclophosphamide, Doxorubicin, Vincristine w/ Irinotecan and Temozolomide in Ewings Sarcoma
Stopped: Study did not reach primary objective; study did not accrue enough patients.
United States3 participantsStarted 2011-05
Plain-language summary
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.
Who can participate
Age range13 Years
SexALL
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Inclusion Criteria:
* Histologically or cytologically confirmed diagnosis of metastatic Ewing's sarcoma.
* Patients must have measurable disease defined as lesions that can be measured by medical imaging techniques such as CT or MRI. Ascites, pleural fluid, bone marrow disease, lesions seen on scan will not be considered measurable.
* Patients must have metastatic disease.
* Age 13 years or older
* Life expectancy of at least 3 months.
* ECOG performance status of \<= 3.
* Normal hepatic function (Direct bilirubin \<1.5mg/dl, SGOT or SGPT \<3x upper limit of normal).
* Left Ventricular Ejection fraction of at least 50%.
* Adequate renal function: Creatinine clearance \>= 50 ml/min or Serum creatinine \< 1.5 x ULN for age.
* Adequate bone marrow reserve (defined as an absolute peripheral granulocyte count of \>=1500/mm3, platelet count of \>=75,000/mm3); unless bone marrow infiltrated with metastatic Ewing's sarcoma; ANC \>= 500 and Platelet \>= 50,000 mm3.
* Ability to understand and willing to sign a written informed consent document.
* Patients of childbearing potential must agree to use an effective method of contraception.
Exclusion Criteria:
* No prior chemotherapy for Ewing's sarcoma; No prior doxorubicin, temozolomide or irinotecan.
* Known hypersensitivity to any of the components of the protocol drugs.
* Clinically significant unrelated systemic illness (such as serious infections requiring active systemic intravenous antibiotic therapy; cardiovascular disease \[c…
What they're measuring
1
Overall Response Rate (Partial and Complete Response)