CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 175 enrolled
Drug / intervention
pp65-shLAMP DC with GM-CSF +4 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02465268
NCT02465268Phase 2Completed
CompareCT.gov

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

University of Florida·interventional·Posted Jun 8, 2015·Updated Jan 14, 2025

In Brief

A Phase 2 clinical trial evaluating pp65-shLAMP DC with GM-CSF, unpulsed PBMC and saline, and 3 other interventions for Glioblastoma Multiforme and 4 related conditions. Completed, enrolled 175 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlioblastoma Multiforme, Glioblastoma, Malignant Glioma, Astrocytoma, Grade IV, GBM
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 8, 2015
Enrollment StartAug 9, 2016
Primary CompletionNov 30, 2023
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 11.1 years ago

Interventions

pp65-shLAMP DC with GM-CSFbiological

unpulsed PBMC and salinebiological

Tddrug

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.

Salinedrug

pp65-flLAMP DC with GM-CSFbiological