Peptide Vaccine Focusing on Prevention of the Recurrence for Bladder Cancer

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the clinical efficacy for the prevention of the recurrence for bladder cancer after TUR-Bt

Detailed Description
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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.

Official Title
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Phase II Study of Bladder Cancer Using Novel Tumor Antigens for Prevention of the Recurrence for Bladder Cancer After TUR-Bt

Conditions
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Bladder Cancer

Intervention / Treatment
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* Biological: MPHOSPH1 and DEPDC1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria DISEASE CHARACTERISTICS Bladder cancer without solitary and low grade tumor Protein expression of MPHOSPH1 and DEPDC1 on the tumor PATIENTS CHARACTERISTICS Patients must be treated completely by Transurethral resection of the bladder tumor(TUR-Bt), and must have no residual tumor after re-TUR-Bt. Patients without the first time, solitary, low grade1 bladder cancer, which tumor is diagnosed histologically transitional cell carcinoma of bladder. Patients must be treated by TUR-BT, who are able to treated by Intravesical Bacillus calmette-guerin (BCG) for adjuvant therapy ECOG performance status of 0 to 1 Age ≥ 20 years, ≤80 years WBC≥ 2,000/mm³, ≤15000/mm³ Platelet count ≥ 75000/mm³ AST, ALT ≤150 IU/l Total bilirubin ≤ 3.0 mg/dl Creatinine ≤ 3.0 mg/dl Samples of bladder cancer must express MPHOSPH1 or DEPDC1 Able and willing to give valid written informed consent Exclusion Criteria: Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception) Breastfeeding Patients willing to childbearing ( Refusal or inability to use effective means of contraception) Serious infections requiring antibiotics Concomitant treatment with steroids or immunosuppressing agent Other malignancy difficult to control. Decision of unsuitableness by principal investigator or physician-in-charge

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: MPHOSPH1 and DEPDC1|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate after surgery (TUR-BT) |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| feasibility |  | 2 years | 
| CTL response |  | 2 years | 
| CD8 population |  | 2 years | 
| Change in level of regulatory T cells |  | 2 years | 
| Overall survival |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epitope peptide, CTL, TUR-Bt, Bladder cancer, Vaccination, Bladder cancer after surgery