Vaccine Therapy for the Treatment of Newly Diagnosed Glioblastoma Multiforme

Summary

The purpose of this research study is to determine if an investigational dendritic cell vaccine, called pp65 DC, is effective for the treatment of a specific type of brain tumor called glioblastoma (GBM) when given with stronger doses of routine chemotherapy.

Timeline

Start

2016-08-09

Primary completion

2023-11-30

Completion

2023-11-30

Outcome

Missed primary endpoint

registry analysis (superiority test); pp65-shLAMP DC With GM-CSF and Td (Arm 1) vs Unpulsed PBMC and Saline (Arm 3); p = 0.196; NCT02465268 ↗

registry analysis (superiority test); pp65-flLAMP DC With GM-CSF and Td (Arm 2) vs Unpulsed PBMC and Saline (Arm 3); p = 0.196; NCT02465268 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	pp65-flLAMP DC	Vaccine	—	Subcutaneous
Subject	pp65-shLAMP DC	Vaccine	—	Subcutaneous
Background	GM-CSF	Protein / enzyme biologic	—	Subcutaneous
Background	Td	Unknown	—	—

Indications