This is a pilot protocol to evaluate the safety, feasibility, and immunogenicity of a personalized breast cancer vaccine based utilizing whole exome sequencing data of a patient's residual breast tumor following neoadjuvant chemotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Removal of white blood cells (leukocytes) from the blood. The dendritic cells are harvested from the white blood cells that are collected and trained to recognize the specific abnormal proteins found in the tumor sample. One needle is inserted in each arm. An apheresis machine removes blood from the vein in one arm, separates and retains the leukocytes from the blood, and then returns the rest of the blood to the other arm.
The vaccine will be given intranodally (inguinal or axillary) under ultrasound guidance using a dose of 40-50 million cells three times spaced 2 weeks apart for the initial priming sequence. 3 doses of the priming vaccines are given once every 2 weeks. 2 booster shots (if available) will be given 6 months and 12 months following completion of initial priming vaccines.
Moffitt Cancer Center
Tampa, Florida, United States
RECRUITINGPercentage of patients enrolled who successfully undergo at least one vaccination.
Successful production and administration of DC1 priming vaccination sequence in greater than 60% of patients enrolled.
Time frame: Up to 3 Years
Number of participants who achieve Immunogenicity after administration of vaccine
Immunogenicity will be determined by ELISpot and reactive T-Cell Receptor (TCR) expansion. ELISPot is an enzyme-linked immunospot assay. It is a highly sensitive immunoassay that measures the frequency of cytokine-secreting cells at the single-cell level.
Time frame: Up to 3 Years
Disease Free Survival (DFS)
Disease Free Survival will be measured as the length of time after treatment to cancer recurrence or death from any cause.
Time frame: Up to 3 Years
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