Vaccine for Patients With Newly Diagnosed or Recurrent Low-Grade Glioma
|ClinicalTrials.gov Identifier: NCT01635283|
Recruitment Status : Active, not recruiting
First Posted : July 9, 2012
Last Update Posted : February 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|Adult Diffuse Astrocytoma Adult Mixed Glioma Adult Oligodendroglioma Recurrent Adult Brain Tumor Adult Oligoastrocytoma||Biological: tumor lysate-pulsed autologous dendritic cell vaccine Other: laboratory biomarker analysis||Phase 2|
I. To determine the 5-year progression-free survival (PFS), using intradermal injections of autologous dendritic cells harvested from peripheral blood precursors and pulsed (co-cultured) with tumor lysate derived from surgical tissues in patients with low-grade gliomas.
I. To monitor overall survival (OS), and cellular immune responses in brain tumor patients injected with tumor lysate-pulsed dendritic cells.
Patients receive tumor lysate-pulsed autologous dendritic cell vaccine intradermally (ID) on days 0, 14, and 28.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Clinical Trial Evaluating Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen for the Treatment of Low-grade Glioma|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: Treatment (tumor lysate-pulsed autologous dendritic cells)
Patients receive autologous glioma tumor lysate-pulsed autologous dendritic cell vaccine ID on days 0, 14, and 28.
Biological: tumor lysate-pulsed autologous dendritic cell vaccine
Other: laboratory biomarker analysis
- Progression-free survival of low grade glioma patients treated with autologous dendritic cells pulsed with autologous tumor lysate [ Time Frame: Up to 5 years ]Cox regression will be used.
- Overall survival [ Time Frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months. ]
- Anti-tumor immune responses [ Time Frame: upto 5 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01635283
|United States, California|
|Jonsson Comprehensive Cancer Center|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Robert Prins||Jonsson Comprehensive Cancer Center|