A Phase II Pilot Study of Cyclophosphamide, Doxorubicin, Vincristine Alternating With Irinotecan and Temozolomide in Patients With Newly Diagnosed Metastatic Ewing's Sarcoma

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.

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Intervention(s):

  • drug : Mesna
  • drug : Pegfilgrastim
  • drug : Irinotecan
  • drug : Cytoxan
  • drug : Temozolomide
  • drug : Doxorubicin
  • drug : Vincristine

Phase: Phase 2

Eligibility

Ages Eligible For Study:

13 Years - N/A

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.

External Links

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Contact information

Primary Contact:

Maria Ahern 650-725-6413

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

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