NCT01313884

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bone Cancer
• Ewing's Sarcoma

Interventions

Type	Name	Description
DRUG	Irinotecan	50 mg/m2/day x 5 days
DRUG	Vincristine	2 mg/m2 to a maximum of 2 mg
DRUG	Temozolomide	100 mg/m2/day x 5 days followed by 2 weeks treatment-free
DRUG	Doxorubicin	Starting dose 75 mg/m2 to a maximum of 450mg/m2
DRUG	Cytoxan	1200 mg/m2
DRUG	Pegfilgrastim	6 mg subcutaneous within 24 to 48 hours after each Regimen A cycle

Timeline

• Start date: 2011-05-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2011-03-14
• Last updated: 2017-11-24
• Results posted: 2017-02-02

Locations

1 site across 1 country: United States