Clinical trial NCT00633204: Peptide Vaccine Focusing on Prevention of the Recurrence for Bladder Cancer
Official title: Phase II Study of Bladder Cancer Using Novel Tumor Antigens for Prevention of the Recurrence for Bladder Cancer After TUR-Bt
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Bladder Cancer
Keywords: Epitope peptide, CTL, TUR-Bt, Bladder cancer, Vaccination
Bladder cancer after surgery
Lead sponsor: Iwate Medical University
Sponsor class: OTHER
Collaborators: name: Human Genome Center, Institute of Medical Science, University of Tokyo
First posted: 2008-03-11
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria DISEASE CHARACTERISTICS

1. Bladder cancer without solitary and low grade tumor
2. Protein expression of MPHOSPH1 and DEPDC1 on the tumor

PATIENTS CHARACTERISTICS

1. Patients must be treated completely by Transurethral resection of the bladder tumor(TUR-Bt), and must have no residual tumor after re-TUR-Bt.
2. Patients without the first time, solitary, low grade1 bladder cancer, which tumor is diagnosed histologically transitional cell carcinoma of bladder.
3. Patients must be treated by TUR-BT, who are able to treated by Intravesical Bacillus calmette-guerin (BCG) for adjuvant therapy
4. ECOG performance status of 0 to 1
5. Age ≥ 20 years, ≤80 years
6. 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
7. Samples of bladder cancer must express MPHOSPH1 or DEPDC1
8. Able and willing to give valid written informed consent

Exclusion Criteria:

1. Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
2. Breastfeeding
3. Patients willing to childbearing ( Refusal or inability to use effective means of contraception)
4. Serious infections requiring antibiotics
5. Concomitant treatment with steroids or immunosuppressing agent
6. Other malignancy difficult to control.
7. Decision of unsuitableness by principal investigator or physician-in-charge

Primary outcomes:
measure: Recurrence rate after surgery (TUR-BT)
timeFrame: 2 years
Secondary outcomes:
measure: feasibility
timeFrame: 2 years
measure: CTL response
timeFrame: 2 years
measure: CD8 population
timeFrame: 2 years
measure: Change in level of regulatory T cells
timeFrame: 2 years
measure: Overall survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Morioka
country: Japan
facility: Iwate Medical University School of Medicine
state: Iwate
Study officials:
affiliation: Department of Urology, Iwate Medical University
name: Tomoaki Fujioka, M.D. & Ph.D.
role: STUDY_CHAIR
References:
citation: Kanehira M, Katagiri T, Shimo A, Takata R, Shuin T, Miki T, Fujioka T, Nakamura Y. Oncogenic role of MPHOSPH1, a cancer-testis antigen specific to human bladder cancer. Cancer Res. 2007 Apr 1;67(7):3276-85. doi: 10.1158/0008-5472.CAN-06-3748.
citation: Kanehira M, Harada Y, Takata R, Shuin T, Miki T, Fujioka T, Nakamura Y, Katagiri T. Involvement of upregulation of DEPDC1 (DEP domain containing 1) in bladder carcinogenesis. Oncogene. 2007 Sep 27;26(44):6448-55. doi: 10.1038/sj.onc.1210466. Epub 2007 Apr 23.