drugset / Trial / NCT02549833
Neo-adjuvant Evaluation of Glioma Lysate Vaccines in WHO Grade II Glioma
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a pilot neoadjuvant vaccine study in adults with WHO grade II glioma, for which surgical resection of the tumor is clinically indicated. Co-primary objectives are to determine: 1) the safety and feasibility of the neoadjuvant approach; and 2) whether the regimen increases the level of type-1 chemokine CXCL10 and vaccine-specific (i.e., reactive to GBM6-AD) CD8+ T-cells in tumor-infiltrating leukocytes (TILs) in the surgically resected glioma.
Timeline
- Start
- 2016-10-17
- Primary completion
- 2022-08-15
- Completion
- 2024-08-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hiltonol | Other / unclassified | 1.4 mg | Subcutaneous |
| Subject | Imiquimod | Other / unclassified | 1 mg | Subcutaneous |