Dendritic Cell Vaccine for Patients With Brain Tumors
The main purpose of this study is to evaluate the most effective immunotherapy vaccine components in patients with malignant glioma. Teh investigators previous phase I study (IRB #03-04-053) already confirmed that this vaccine procedure is safe in patients with malignant brain tumors, and with an indication of extended survival in several patients. However, the previous trial design did not allow us to test which formulation of the vaccine was the most effective. This phase II study will attempt to dissect out which components are most effective together. Dendritic cells (DC) (cells which "present" or "show" cell identifiers to the immune system) isolated from the subject's own blood will be treated with tumor-cell lysate isolated from tumor tissue taken from the same subject during surgery. This pulsing (combining) of antigen-presenting and tumor lysate will be done to try to stimulate the immune system to recognize and destroy the patient's intracranial brain tumor. These pulsed DCs will then be injected back into the patient intradermally as a vaccine. The investigators will also utilize adjuvant imiquimod or poly ICLC (interstitial Cajal-like cell) in some treatment cohorts. It is thought that the host immune system might be taught to "recognize" the malignant brain tumor cells as "foreign" to the body by effectively presenting unique tumor antigens to the host immune cells (T-cells) in vivo.
Biological: autologous tumor lysate-pulsed DC vaccination
Biological: Tumor lysate-pulsed DC vaccination+0.2% resiquimod
Biological: Tumor-lysate pulsed DC vaccination +adjuvant polyICLC
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Most effective combination of DC vaccine components [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
- Time to tumor progression and overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||September 2010|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
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|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01204684
|United States, California|
|University of Los Angeles, California||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Emma Young, R.N. 310-267-2621 firstname.lastname@example.org|