Dendritic Cell Vaccine With Imiquimod for Patients With Malignant Glioma
Malignant gliomas are very aggressive and among the most common of brain tumors. A diagnosis carries with it a median survival of approximately 24 months. The current standard treatment of surgical resection followed by radiation therapy and chemotherapy has not substantially prolonged survival and even the few treatment options shown to exhibit small increases in survival primarily benefit certain (i.e., young) patient subpopulations.
Cancer vaccines represent one novel therapy for malignant gliomas. The goal is for the body to recognize the tumor cells are foreign and produce its own response to fight off recurring tumor cells. A promising means of causing an immune response so the body can create this immunity is through the use of dendritic cell (DC) vaccines.
|Malignant Glioma||Biological: Dendritic Cell Vaccine in combination with Imiquimod cream||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||A Phase I Trial of Surgical Resection Followed by Vaccination With Dendritic Cells Pulsed With Tumor Lysate With Imiquimod for Patients With Malignant Glioma|
- safety of an autologous tumor lysate- loaded dendritic cell (DC) vaccine with Imiquimod cream application [ Time Frame: 1 year ]Safety relative to vaccine will be monitored in terms of Serious Adverse Events according to FDA regulations and recorded on a MedWatch 3500a form. A Data Safety Monitoring Committee will meet every 6 months to review AEs/SAE's. In the event of any subject death within a 30 day period following study agent administration, the DSMC will review the death within that time frame. If two deaths are deemed to be "probably" or "definitely' related to study agent administration, all study agent administrations will be stopped and the FDA and IRB will be notified of study cessation.
- progression free survival of patients after they receive tumor lysate-loaded DC vaccine with Imiquimod cream application. [ Time Frame: 1 year ]
|Study Start Date:||October 2009|
|Study Completion Date:||October 2016|
|Primary Completion Date:||November 14, 2014 (Final data collection date for primary outcome measure)|
Biological: Dendritic Cell Vaccine in combination with Imiquimod cream
After a successful complete resection of malignant glioma, patients will receive a total of 3 vaccines, each are 2 weeks apart. Imiquimod cream will be applied prior to and after each vaccination.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01792505
|United States, California|
|Cedars Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|Principal Investigator:||John Yu, MD||Cedars-Sinai Medical Center|