Dendritic Cell Vaccine for Patients With Brain Tumors
|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: NCT01204684|
Recruitment Status : Active, not recruiting
First Posted : September 17, 2010
Last Update Posted : October 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Glioma Anaplastic Astrocytoma Anaplastic Astro-oligodendroglioma Glioblastoma||Biological: autologous tumor lysate-pulsed DC vaccination Biological: Tumor lysate-pulsed DC vaccination+0.2% resiquimod Biological: Tumor-lysate pulsed DC vaccination +adjuvant polyICLC||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Clinical Trial Evaluating Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen +/- Toll-like Receptor Agonists for the Treatment of Malignant Glioma|
|Actual Study Start Date :||October 8, 2010|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||October 2019|
Experimental: Tumor Lysate-pulsed DC vaccination
Cohort #1 will receive autologous tumor lysate-pulsed DC vaccination together with a placebo cream or intramuscular injection of saline.
|Biological: autologous tumor lysate-pulsed DC vaccination|
Experimental: Tumor lysate-pulsed DC vaccination+0.2% resiquimod.
Cohort #2 will receive autologous tumor lysate-pulsed DC vaccination together with adjuvant 0.2% resiquimod.
|Biological: Tumor lysate-pulsed DC vaccination+0.2% resiquimod|
Experimental: Tumor-lysate pulsed DC vaccination +adjuvant polyICLC.
Cohort #3 will receive autologous tumor lysate-pulsed DC vaccination together with adjuvant poly ICLC (TLR3 agonist).
|Biological: Tumor-lysate pulsed DC vaccination +adjuvant polyICLC|
- Most effective combination of DC vaccine components [ Time Frame: 6 weeks ]
- Time to tumor progression and overall survival [ Time Frame: 2 years ]
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): NCT01204684
|United States, California|
|University of Los Angeles, California|
|Los Angeles, California, United States, 90095|