The purpose of this study is to evaluate the clinical efficacy for the prevention of the recurrence for bladder cancer after TUR-Bt
DEP domain containing 1(DEPDC1) and M phase phosphoprotein 1(MPHOSPH1) have been identified using genome-wide expression profile analysis by the use of cDNA microarray in our previous studies. The investigators have determined the HLA-A\*2402 restricted epitope peptides derived from DEPDC1, DEPDC1-9-294, and MPHOSPH1, MPHOSPH1-9-278. These epitopes showed strong IFN-g production when stimulated with the appropriate targets expressed the appropriate protein and HLA-A\*2402. Furthermore, when vaccinated these peptides, specific CTLs were determined after the vaccination. Therefore we focused on the prevention of the recurrence of the bladder cancer after surgery using these peptides.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
150
DEPDC1-9-294, and/or MPHOSPH1-9-278 will be administered by subcutaneously injection once every week after curative surgery 8 times and BCG in bladder simultaneously. Then, DEPDC1-9-294, and/or MPHOSPH1-9-278 will be administered once every month. These peptides are determined to administer in accordance with the protein expression using immunohistochemical staining. These peptides are conjugated with Montanide ISA 51 as an adjuvant.
Iwate Medical University School of Medicine
Morioka, Iwate, Japan
Recurrence rate after surgery (TUR-BT)
Time frame: 2 years
feasibility
Time frame: 2 years
CTL response
Time frame: 2 years
CD8 population
Time frame: 2 years
Change in level of regulatory T cells
Time frame: 2 years
Overall survival
Time frame: 5 years
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