Immunotherapy Targeted Against Cytomegalovirus in Patients With Newly-Diagnosed WHO Grade IV Unmethylated Glioma
Status:
Suspended
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
Summary
This single-arm phase II study will assess the impact of tetanus pre-conditioning and
adjuvant Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) on overall survival of
patients newly diagnosed with World Health Organization (WHO) Grade IV glioblastoma who have
undergone definitive tumor resection, are cytomegalvirus (CMV) positive and unmethylated, and
completed standard temozolomide (TMZ) and radiation treatment. After completion of the
standard of care radiotherapy with concurrent TMZ, patients will receive 1 cycle of
dose-intensified TMZ followed by pp65-loaded dendritic cell (DC) vaccination beginning on day
23.