Vigil + Irinotecan and Temozolomide in Ewing's Sarcoma
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 140
Summary
- Conditions
- Ewing Family of Tumors
- Ewing Sarcoma
- Ewing's Sarcoma Metastatic
- Ewing's Tumor Metastatic
- Ewing's Tumor Recurrent
- Sarcoma
- Neoplasms
- Sarcoma, Ewing
- Neoplasms by Histologic Type
- Neoplasms, Bone Tissue
- Neoplasms, Connective and Soft Tissue
- Neoplasms, Connective Tissue
- Rare Diseases
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Group A (i) oral temozolomide 100 mg/m2 daily (Days 1 - 5, total dose 500 mg/m2/cycle), (ii) oral irinotecan 50 mg/m2 daily (Days 1 - 5, total dose 250mg/m2/cycle), and (iii) Vigil 1.0 x 10e6 cells/injection cells/injection, intradermally on Day 15. or Group B (i) (oral temozolomide 100 mg/m2 daily (Days 1 - 5, total dose 500 mg/m2/cycle), and (ii) oral irinotecan 50 mg/m2 daily (Days 1 - 5, total dose 250mg/m2/cycle).Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 2 years and 125 years
- Gender
- Both males and females
Description
Participants will be managed in an outpatient setting. Hematologic function, liver enzymes, renal function and electrolytes will be monitored. Blood for immune function analyses including IFN?-ELISPOT analysis of cytotoxic T cell activation in response to autologous tumor antigens will be collected ...
Participants will be managed in an outpatient setting. Hematologic function, liver enzymes, renal function and electrolytes will be monitored. Blood for immune function analyses including IFN?-ELISPOT analysis of cytotoxic T cell activation in response to autologous tumor antigens will be collected at tissue procurement, post-procurement screening and Day 1 (prior to chemotherapy administration) at Cycles 2, 4, and 6, end of treatment (EOT), 3 months after EOT, and every 6 months thereafter. Blood for ctDNA analysis will be collected at tissue procurement, prior to chemotherapy administration at baseline and on Day 1 prior to chemotherapy administration at Cycles 2, 3, 4, and 6, and EOT.
Tracking Information
- NCT #
- NCT03495921
- Collaborators
- Not Provided
- Investigators
- Study Director: Luisa Manning, MD Gradalis, Inc.
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