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Therapeutic Areas: Oncology | Neurology | Family Medicine
Disease Category: Brain Cancer
Location: United States, CA
A Phase II Clinical Trial Evaluating DCVax-Brain, Autologous Dendritic Cells Pulsed with Tumor Lysate Antigen for the Treatment of Glioblastoma Multiforme
You have been asked to participate in this research study because you have a form of brain cancer that may not be best treated by surgery with radiation and with chemotherapy alone. The purpose of this study is to determine whether an investigational agent called DCVax-Brain, can slow the recurrence of your brain rumor and whether it can extend overall survival. An investigational agent is one that is not approved by the U.S. Food and Drug Administration (FDA). This study agent is made from the subject’s own blood cells, which have been exposed to the subject’s own tumor tissue. Other purposes of this trial are to test the safety and activity of DCVax-Brain 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 study will consist of three phases: the initial evaluation phase (also known as the screening phase), the active treatment phase (which lasts up to 36 months), and the follow-up phase in which your medical condition will be followed for the rest of your life.
Approximately 240 subjects will be enrolled (160 subjects will receive the DCVax-Brain treatment, and 80 control subjects will receive a placebo ([inactive substance]). This research trial will be done at about 40 study sites in the United States, with about 10-30 subjects enrolled at each site. Comparison of survival times and tumor growth times between subjects receiving the DCVax-Brain and subjects receiving placebo will help to determine if this experimental treatment has had an impact on the course of this disease.
Patient Inclusion/Exclusion Criteria:
- See http://clinicaltrials.coh.org for additional information.
City of Hope
1500 East Duarte Road
Duarte, CA 91010-3000
Phone: 866-896-HOPE (4673)
Research Center Information: City of Hope
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