Vaccine for Patients With Newly Diagnosed or Recurrent Low-Grade Glioma
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|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 ]
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): NCT01635283
|United States, California|
|Jonsson Comprehensive Cancer Center|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Robert Prins||Jonsson Comprehensive Cancer Center|