Imiquimod/BTIC Lysate-Based Vaccine Immunotherapy for Diffuse Intrinsic Pontine Glioma in Children and Young Adults
Vaccine will be produced by the University Of Minnesota Molecular and Cellular Therapeutics
Facility using the established brain tumor initiating cell (BTIC) cell line GBM-6 as the
antigen source. Vaccine administration will begin at four weeks (week 10) following
completion of radiation therapy and will be given every two weeks for four doses. At the
time of the 1st and 3rd vaccinations, additional 180 cGy fractions will be delivered in
single doses in a novel effort to induce NKG2D ligand upregulation (thereby "sensitizing"
residual tumor to lymphocyte attack). The total radiation dose for each patient will be 5940
cGy. Subsequent vaccinations will be given every four weeks and will continue to a maximum
of one year from study enrollment, by which time median survival will have passed based on
historical data. Imaging will be obtained at study entry (post radiation therapy) and every
eight weeks thereafter to eighteen months, after which time the interval between imaging
follow-up episodes will be determined by the patient's clinical status. Imaging will include
MRI of the brain using our current institutional brain tumor imaging protocol. Imaging will
also include SPECT/MRI and perfusion MRI. FDG-PET imaging may be used in certain cases to
differentiate tumor necrosis from progression.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determined as Grade 3 or 4 toxicity observation after dosing with BTIC vaccination. Toxicity will be graded using the NCI's Common Terminology Criteria for Adverse Events (CTCAE 4.0) in terms of local, regional and systemic events.
Within 24 hours of vaccination
Christopher Moertel, M.D.
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
|Masonic Cancer Center, University of Minnesota||Minneapolis, Minnesota 55455|