Cyclophosphamide, Doxorubicin, Vincristine w/ Irinotecan and Temozolomide in Ewings Sarcoma
Overview[ - collapse ][ - ]
Purpose | 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. |
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Condition | Bone Cancer Ewing's Sarcoma |
Intervention | Drug: Irinotecan Drug: Vincristine Drug: Temozolomide Drug: Doxorubicin Drug: Cytoxan Drug: Pegfilgrastim Drug: Mesna |
Phase | Phase 2 |
Sponsor | Stanford University |
Responsible Party | Stanford University |
ClinicalTrials.gov Identifier | NCT01313884 |
First Received | March 10, 2011 |
Last Updated | January 10, 2014 |
Last verified | January 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | March 10, 2011 |
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Last Updated Date | January 10, 2014 |
Start Date | May 2011 |
Estimated Primary Completion Date | June 2016 |
Current Primary Outcome Measures | Overall Response Rate (Partial and Complete Response) [Time Frame: 24 months] [Designated as safety issue: No] |
Current Secondary Outcome Measures | progression free survival [Time Frame: 24 months] [Designated as safety issue: Yes] |
Descriptive Information[ + expand ][ + ]
Brief Title | Cyclophosphamide, Doxorubicin, Vincristine w/ Irinotecan and Temozolomide in Ewings Sarcoma |
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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 |
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. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 2 |
Study Design | Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition |
|
Intervention | Drug: Irinotecan 50 mg/m2/day x 5 days Other Names:
2 mg/m2 (capped at 2mg total do) Other Names:
100 mg/m2/day x 5 days Other Names:
75 mg/m2 Other Names:
1200 mg/m2 Other Names:
6 mg Other Names: NeulastaDrug: Mesna 240 mg/m2 in 50 ml NS Other Names:
|
Study Arm (s) | Experimental: Combination Therapy Regimen A alternate with Regimen B every 21 days Regimen A: Cytoxan=1200mg/m2 Doxorubicin=75mg/m2 (Maxiumum allowed dose 450mg/m2) Vincristine=2mg/m2 (capped at 2mg total dose) Regimen B: Irinotecan=50 mg/m2/day x 5 days Temozolomide=100 mg/m2/day x 5 days followed by two weeks of treatment-free period. |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Active, not recruiting |
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Estimated Enrollment | 20 |
Estimated Completion Date | June 2016 |
Estimated Primary Completion Date | June 2014 |
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. |
Gender | Both |
Ages | 13 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01313884 |
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Other Study ID Numbers | SARCOMA0007 |
Has Data Monitoring Committee | Yes |
Information Provided By | Stanford University |
Study Sponsor | Stanford University |
Collaborators | Amgen |
Investigators | Principal Investigator: Kristen N. Ganjoo Stanford University |
Verification Date | January 2014 |
Locations[ + expand ][ + ]
Stanford University School of Medicine | Stanford, California, United States, 94305 |
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