Dendritic Cell Vaccine for Patients With Brain Tumors
|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 ]
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|