The purpose of this study is to evaluate the safety and clinical efficacy of novel vaccination for advanced bladder cancer.
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. We 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 safety and efficacy of novel vaccination for the advanced bladder cancer patients who already showed resistance to standard chemotherapies or radiotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
DEPDC1-9-294, and/or MPHOSPH1-9-278 will be administered by subcutaneously injection once every week for 3 months thereafter once two weeks. 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
feasibility (toxicities as assessed by NCI-CTCAE version 3)
Time frame: 3 years
objective response rate as assessed by RECIST criteria
Time frame: 3 years
CTL response
Time frame: 3 years
CD8 population
Time frame: 3 years
Change in level of regulatory T cells
Time frame: 3 years
survival
Time frame: 3 years
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