A Phase II Clinical Trial Evaluating Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen for the Treatment of Low-grade Glioma
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
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival of low grade glioma patients treated with autologous dendritic cells pulsed with autologous tumor lysate
Cox regression will be used.
Up to 5 years
Jonsson Comprehensive Cancer Center
United States: Food and Drug Administration
|Jonsson Comprehensive Cancer Center||Los Angeles, California 90095|