A Phase II Clinical Trial Evaluating DCVax®-Brain, Autologous Dendritic Cells Pulsed with Tumor Lysate Antigen for the Treatment of Glioblastoma Multiforme (GBM).

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Study Number:
020221

Topic:
Glioblastoma

Principal Investigator:
Chaudhary

Addtional Investigators:
Ady Kendler
Christopher M McPherson
Ronald E Warnick

Ongoing:
Ongoing

Place:
University Hospital

Overview:

The goal of this clinical trial is to assess the activity and safety of an investigational agent called DCVax-Brain which is made from the patient’s own blood cells which have been exposed to the patients own tumor tissue. Approximately 160 patients will receive the DCVax-Brain treatment and 80 control patients will receive a placebo (an inactive substance). Comparison of survival times and tumor growth between patients receiving the DCVax-Brain and the patients receiving the placebo will be used to determine whether this experimental treatment has had an impact on the course of this disease. The purpose of this clinical trial study is to determine whether DCVax-Brain can slow the growth and recurrence of your brain tumor and whether DCVax-Brain can extend overall survival. Other goals of the study are to test the safety and activity of DCVax-Brain and to determine whether the study agent causes an immune response (how your body recognizes and defends itself against substances that appear foreign and harmful to your body) against your cancer cells as compared to standard treatment or another experimental treatment. The clinical trial will consist of three phases: the initial evaluation phase (also known as the screening phase), the active treatment phase, and the follow-up phase. During the evaluation phase you will undergo some testing to indicate whether you can participate. The next phase, the active treatment phase, is when patients are treated with DCVax-Brain or placebo. During this phase, which lasts up to 36 months, you will be asked to return to the clinic once every two months for MRIs and other tests to determine how you are doing. During the follow-up phase, which starts after the 36 months is completed or after you leave the trial for any reason, you and/or a designated contact will be contacted every third month to ask how you are doing for the rest of your life. About 240 patients will take part in this study at various sites.  About thirty 30 people will take part in this study at The University of Cincinnati.

Qualifications:
To be eligible for the study you must be 18 years or older and have a brain tumor.

Contact:
For more information, please contact Alison Kastl, BS, CCRC, Director of Clinical Trials, at kastla@ucmail.uc.edu or (513) 584-0436.

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