Recurrent GBM Stem Cell Tumor Amplified RNA Immunotherapy Trial
- To evaluate the feasibility and safety of an autologous brain tumor stem cell
mRNA-loaded dendritic cell vaccine in adult patients with recurrent glioblastoma
- To assess humoral and cellular immune responses to vaccination.
- To compare the proportion of vaccinated patients alive at 6 months from the time of
surgery for recurrent tumor with matched historical cohorts.
OUTLINE: Patients undergo surgical resection of tumor. Tumor tissue samples are collected to
isolate brain tumor stem cells (BTSCs) and for extraction and amplification of BTSC-specific
mRNA. Within 4 weeks after surgical resection, patients undergo leukapheresis over 4 hours
to generate dendritic cells (DCs). Patients also undergo leukapheresis at 1 week after the
third vaccination and then at least every 3 months as needed for generation of additional
Patients receive autologous BTSC mRNA-loaded DC vaccine intradermally once weekly for 3
weeks and then once monthly in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Feasibility and safety
Gordana Vlahovic, MD
United States: Food and Drug Administration
|Duke University Medical Center||Durham, North Carolina 27710|