NCT02465268

Vaccine Therapy for the Treatment of Newly Diagnosed Glioblastoma Multiforme

ATTAC-II: A Phase II Randomized, Blinded, and Placebo-controlled Trial of CMV RNA-Pulsed Dendritic Cells With Tetanus-Diphtheria Toxoid Vaccine in Patients With Newly-Diagnosed Glioblastoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 175 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Dendritic cells (DC) are involved in activating, or turning-on, your body's immune system. Your immune system helps guard your body from germs, viruses, and other threats. Although dendritic cells are very strong, the number of them in the body is not high enough to cause a powerful immune response; therefore, more DC are made in a laboratory with cells collected from an individual's blood. In this study, we will make a vaccine that we hope will educate immune cells to target the pp65 antigen, a type of immune marker in GBM, thus resulting in what we call the pp65 DC vaccine. Use of a vaccine that activates your immune system is a type of immunotherapy. It is hoped that by giving the pp65 DC vaccine as a shot under the skin, the immune system will be activated to attack tumor cells in the brain while leaving normal cells alone. To see if the pp65 DC vaccine is effective for the treatment of GBM, subjects will be assigned to different treatment groups. Two groups of subjects will receive the pp65 DC vaccine and one group will receive a placebo.

Conditions

• Glioblastoma Multiforme
• Glioblastoma
• Malignant Glioma
• Astrocytoma, Grade IV
• GBM

Interventions

Type	Name	Description
BIOLOGICAL	pp65-shLAMP DC with GM-CSF
BIOLOGICAL	unpulsed PBMC and saline
DRUG	Td	All subjects will receive a Td booster before study drug dose #1. Subjects in the experimental arms will receive Td skin prep before study drug doses #3, #6, and #9.
DRUG	Saline
BIOLOGICAL	pp65-flLAMP DC with GM-CSF

Timeline

• Start date: 2016-08-09
• Primary completion: 2023-11-30
• Completion: 2023-11-30
• First posted: 2015-06-08
• Last updated: 2025-01-14
• Results posted: 2025-01-14

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study