Cyclophosphamide, Doxorubicin, Vincristine w/ Irinotecan and Temozolomide in Ewings Sarcoma



Status:Terminated
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:13 - Any
Updated:11/25/2017
Start Date:May 2011
End Date:July 2014

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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.


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
[congestive heart failure, recent myocardial infarction, unstable angina, inadequately
controlled hypertension].

- No prior history of chronic diarrhea, bowel obstruction, Crohn's disease or ulcerative
colitis.

- Pregnant or nursing woman are not included in the study.

- HIV-positive patients will be excluded from the study due to risk of infection or
other serious side effects.

- Other medical, psychiatric or social condition incompatible with study treatment.
We found this trial at
1
site
291 Campus Dr
Stanford, California 94305
(650) 725-3900
Stanford University School of Medicine Vast in both its physical scale and its impact on...
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from
Stanford, CA
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