MedTrace Logo

Vaccine Therapy for the Treatment of Newly Diagnosed Glioblastoma Multiforme

NCT02465268 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2025-01-14

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Florida

    lead OTHER

Principal Investigators

  • Duane Mitchell, MD, PhD · University of Florida

  • Maryam Rahman, MD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-09
Primary Completion
2023-11-30
Completion
2023-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02465268 on ClinicalTrials.gov