A Study Evaluating Vaccination of Prostate Cancer Patients With Self Dendritic Cells Expressing MUC1 (MUC1)
|Prostate Cancer||Biological: DC-Tn-MUC1: autologous dendritic cells expressing Tn-MUC1||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||A Phase I/II Study Evaluating the Safety and Efficacy of Vaccination With Autologous Dendritic Cells Loaded With Tn-MUC1 Peptide in Patients With Non-Metastatic Androgen Independent Prostatic Adenocarcinoma.|
- Time to radiographic progression [ Time Frame: Time to radiographic progression defined as the time from the first treatment to the occurence of any metastatic disease ]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.
- Number of participants with adverse events [ Time Frame: Ongoing up to 2 years ]Acute and late toxicities as assessed by NCI CTCAE v 4.0
- Time to PSA progression [ Time Frame: Up to 2 years ]
- Immune response [ Time Frame: Up to 2 years ]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.
- Overall survival [ Time Frame: Up to 2 years ]
- Disease-specific survival [ Time Frame: Up to 2 years ]
|Study Start Date:||February 2009|
|Study Completion Date:||February 2016|
|Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
DC-Tn-MUC1: autologous dendritic cells expressing Tn-MUC1. 1.2 x 10e7 dendritic cells per dose. 5 administrations (doses)may be given in total.
Biological: DC-Tn-MUC1: autologous dendritic cells expressing Tn-MUC1
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.).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00852007
|Hamilton Health Sciences|
|Hamilton, Ontario, Canada|
|Principal Investigator:||Pierre P. Major, MD||Hamilton Health Sciences Corporation|