drugset / Trial / NCT02549833

Neo-adjuvant Evaluation of Glioma Lysate Vaccines in WHO Grade II Glioma

NCT02549833

Phase 1 Completed 28 enrolled Jennie Taylor University of Minnesota · collab
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

EvaluationDrugModalityDoseRoute
Subject Hiltonol Other / unclassified 1.4 mg Subcutaneous
Subject Imiquimod Other / unclassified 1 mg Subcutaneous