Dendritic Cell Vaccine With Imiquimod for Patients With Malignant Glioma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01792505|
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : April 21, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Malignant Glioma||Biological: Dendritic Cell Vaccine in combination with Imiquimod cream||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||November 14, 2014|
|Actual Study Completion Date :||October 2016|
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01792505
|United States, California|
|Cedars Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|Principal Investigator:||John Yu, MD||Cedars-Sinai Medical Center|