Clinical trial NCT01313884: Cyclophosphamide, Doxorubicin, Vincristine w/ Irinotecan and Temozolomide in Ewings Sarcoma
Official title: A Phase II Pilot Study of Cyclophosphamide, Doxorubicin, Vincristine Alternating With Irinotecan and Temozolomide in Patients With Newly Diagnosed Metastatic Ewing's Sarcoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Bone Cancer
Ewing's Sarcoma
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Amgen
First posted: 2011-03-14
Enrollment: 3
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Overall Response Rate (Partial and Complete Response)
timeFrame: Up to 24 months
Secondary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: 24 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Kristen N. Ganjoo
role: PRINCIPAL_INVESTIGATOR
References: