Cyclophosphamide, Doxorubicin, Vincristine w/ Irinotecan and Temozolomide in Ewings Sarcoma
This study is currently recruiting participants.
Verified October 2013 by Stanford University
Information provided by (Responsible Party):
First received: March 10, 2011
Last updated: October 24, 2013
Last verified: October 2013
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase II Pilot Study of Cyclophosphamide, Doxorubicin, Vincristine Alternating With Irinotecan and Temozolomide in Patients With Newly Diagnosed Metastatic Ewing's Sarcoma
Primary Outcome Measures:
- Overall Response Rate (Partial and Complete Response) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- progression free survival [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2014 (Final data collection date for primary outcome measure)
Experimental: Combination Therapy
Regimen A alternate with Regimen B every 21 days
Cytoxan=1200mg/m2 Doxorubicin=75mg/m2 (Maxiumum allowed dose 450mg/m2) Vincristine=2mg/m2 (capped at 2mg total dose)
Irinotecan=50 mg/m2/day x 5 days Temozolomide=100 mg/m2/day x 5 days followed by two weeks of treatment-free period.
50 mg/m2/day x 5 days
2 mg/m2 (capped at 2mg total do)
100 mg/m2/day x 5 days
Other Name: Neulasta
240 mg/m2 in 50 ml NS
|Ages Eligible for Study:
||13 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01313884
|Stanford University School of Medicine
|Stanford, California, United States, 94305 |
|Contact: Maria Ahern 650-725-6413 firstname.lastname@example.org |
|Contact: Cancer Clinical Trials Office (650) 498-7061 email@example.com |
|Principal Investigator: Kristen N. Ganjoo |
|Sub-Investigator: Dr. Neyssa Maria Marina |
|Sub-Investigator: Mahesh Seetharam |
||Kristen N. Ganjoo
No publications provided
History of Changes
|Other Study ID Numbers:
||SARCOMA0007, SU-03082011-7559, 20323
|Study First Received:
||March 10, 2011
||October 24, 2013
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 05, 2013
Neuroectodermal Tumors, Primitive, Peripheral
Neoplasms by Site
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neuroectodermal Tumors, Primitive
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Physiological Effects of Drugs