At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 2-part Trial Comparing Overall Survival of Patients With Metastatic Ewing's Sarcoma Treated With Vigil Versus Gemcitabine and Docetaxel and to Determine Safety Profile of Vigil in Combination With Irinotecan and Temozolomide.
In Brief
A Phase 2 clinical trial evaluating Vigil, Temozolomide, and 3 other interventions for Ewing's Sarcoma. Completed, enrolled 22 participants across 6 sites.
Detailed Summary
A two-part trial in patients with metastic Ewing's sarcoma. Participants in Part 1 will be randomized to receive either Vigil immunotherapy or gemcitabine and docetaxel with the objective of comparing the overall survival between the two arms. Participants enrolled in Part 2 will receive Vigil immunotherapy in combination of temozolomide and irinotecan with the objective to determine the safety profile of the combination treatment.
Study Details
Timeline
Interventions
Vigil 1.0 x 10e7 cells/injection, minimum of 4 to a maximum of 12 administrations.
oral temozolimidetemozolomide 100 mg/m2 daily (Days 1 - 5, total dose 500 mg/m2/cycle)
irinotecan 50 mg/m2 daily (Days 1 - 5, total dose 250mg/m2/cycle), orally or irinotecan 20mg/m2 daily (Days 1 - 5, total dose 100mg/m2/cycle ), intravenously
675 mg/m2 IV at a rate of 10 mg/m2/min on Day 1 and Day 8 every 21 days
75 mg/m2 IV administered on Day 8 and every 21 days