This study investigates the use of the patients own immune cells to treat prostate cancer. Cells are taken from the patient and grown in the laboratory to become specialized immune cells called dendritic cells. Dendritic cells instruct other immune cells to recognize and attack foreign substances such as bacteria, viruses, or abnormal proteins on cancer cells. A protein called Tn-MUC-1 is added to the cells.This protein is present on prostate cancer cells. The modified cells are injected back into the patient, with the intention that the dendritic cells will instruct other immune cells to attack the prostate cancer cells.
Patients undergo one standard apheresis to harvest peripheral mononuclear cells for dendritic cell vaccine preparation. The modified cells (vaccine) are frozen so that multiple injections may be given. Patients my receive up to 5 injections. The vaccine is given either intradermally or into a lymph node. Patients will undergo blood sample collection for immune response studies on the day of treatment and 2 weeks following treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
20
1.2 x 10e7 dendritic cells per dose. One dose delivered intradermally (i.d.) and into a node (i.n.). Two weeks after this,two injections i.d. 2 weeks apart. Optional booster injections at 6 (i.d. and i.n.) and and 12 months (i.d.).
Hamilton Health Sciences
Hamilton, Ontario, Canada
Time to radiographic progression
Radiographic disease as measured by the occurence of any metastatic disease based on modified RECIST 1.0 and/or the appearance of 2 or more new lesions on a bone scan.
Time frame: Time to radiographic progression defined as the time from the first treatment to the occurence of any metastatic disease
Number of participants with adverse events
Acute and late toxicities as assessed by NCI CTCAE v 4.0
Time frame: Ongoing up to 2 years
Time to PSA progression
Time frame: Up to 2 years
Immune response
Immune response defined as the induction of a cellular (CD4/CD8)response measured by CFSE or ICS assay and/or the induction of a humoral response as measured by an increase in specific antibody or the occurence of antibody isotype switching.
Time frame: Up to 2 years
Overall survival
Time frame: Up to 2 years
Disease-specific survival
Time frame: Up to 2 years
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