A Phase III Clinical Trial Evaluating DCVax®-L, Autologous Dendritic Cells Pulsed with Tumor Lysate

A Phase III Clinical Trial Evaluating DCVax®-L, Autologous Dendritic Cells Pulsed with Tumor Lysate Antigen for the Treatment of Glioblastoma Multiforme

ClinicalTrials.gov Identifier: NCT00045968

UCLA IRB #: 11-000686

Sponsor: Northwest Biotherapeutics

Time Frame: Time to tumor progression or death

Purpose: This is a randomized study where neither patient nor doctor will know whether a patient is receiving DCVax-L vaccination or a placebo. DCVax-L consists of two components: autologous (your own) immune cells called dendritic cells (DC) and part of a substance prepared from your tumor cells. The purpose of this clinical trial is to determine whether DCVax-L can slow the growth and recurrence of your brain tumor and whether DCVax-L can extend overall survival. Other goals of this trial are to test the safety and activity of DCVax-L and to determine whether the study agent causes an immune response against your cancer cells as compared to standard treatment or another experimental treatment. The theory of this study is that in boosting the patient's immune response to cancer cells, this can help deter or prevent further tumor recurrence. The procedures involved for this study begin with collection of your white blood cells via a procedure called leukapheresis. This procedure is similar to donating blood and takes approximately 4 hours. Next, your tumor is removed during surgery. A small part is sent to the laboratory where the tumor cells are treated to obtain proteins called the tumor lysate. Your white blood cells, along with the tumor lysate are combined to create the vaccine, DCVax-L. Patients will receive either the study vaccine or a placebo over the course of 3 years and up to 10 injections. MRIs will be performed every 2 months for evaluation purposes.

Principal Investigator: Linda Liau, MD, PhD, MBA

Contact: Emma Billingslea-Yoon, N.P.

Phone: (310) 267-0373

Email: EBillingslea@mednet.ucla.edu