Vaccine for Patients With Newly Diagnosed or Recurrent Low-Grade Glioma
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|ClinicalTrials.gov Identifier: NCT01635283|
Recruitment Status : Completed
First Posted : July 9, 2012
Results First Posted : November 4, 2020
Last Update Posted : November 4, 2020
|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)|
|Actual Enrollment :||5 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|
|Actual Study Start Date :||January 10, 2012|
|Actual Primary Completion Date :||May 13, 2016|
|Actual Study Completion Date :||May 13, 2016|
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 (PFS) of Low Grade Glioma Patients Treated With Autologous Dendritic Cells Pulsed With Autologous Tumor Lysate [ Time Frame: Each case was assessed from the baseline date of surgery to MRI evidence of tumor progression through study completion, up to 44 months. ]a Kaplan-Meier curve of the PFS of our trial patients was created and compared to the PFS of control patients matched for tumor grade, recurrence number, IDH1 status and 1p/19q status.
- Overall Survival (OS) [ Time Frame: The timeframe for OS was from the date of surgery until the date of death from any cause, up to 44 months. ]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. a Kaplan-Meier curve of the OS of our trial patients was created and compared to the OS of control patients matched for tumor grade, recurrence number, IDH1 status and 1p/19q status.
- Anti-tumor Immune Responses [ Time Frame: Tumor for analysis (CD8, Programmed Death (PD)-1, PD-L1, mutation analysis) was collected at the vaccine-related surgery shortly after enrollment. Blood for analysis (IDH1-specific antibodies) was collected at Day 0, before the first vaccine injection. ]
Tumor and peripheral blood samples were collected from each of the participants and analyzed for the following biomarkers:
IDH1-specific antibodies CD8, PD-1, and PD-L1 content, and correlations among those three biomarkers Mutation analysis/sequencing
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|