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
Clinical Trial Information
Trial Contact: Rompola, Melissa; Walton, Sherri
IRB No: Gainsville IRB ATTAC
Protocol Abbrev: ATTAC II
Principal Investigator: Nicholas G. Avgeropoulos, MD
Sub Investigators: Ramakrishna, Naren MD; Ranjan, Surabhi MD
Phase: Drug: Phase II
Age Group: Adult
Secondary Protocol No: ATTAC-II
Treatment: Surgery; Radiation
Applicable Disease Sites: Brain
Therapies Involved: Vaccine plus SOC
ClinicalTrials.gov ID: NCT02465268
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.
1. Age ≥ 18 years.
2. Histopathologically proven newly-diagnosed de novo GBM (secondary GBM not eligible)..
3. Patient must have undergone definitive surgical resection of tumor with less than 3cm x 3cm residual enhancing tumor in longest perpendicular planes by MRI.