This trial is active, not recruiting.

Condition bladder cancer
Treatment mphosph1 and depdc1
Phase phase 2
Sponsor Iwate Medical University
Collaborator Human Genome Center, Institute of Medical Science, University of Tokyo
Start date February 2008
End date November 2011
Trial size 150 participants
Trial identifier NCT00633204, IMU-H18-59-P2


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking double blind (subject, investigator)
Primary purpose prevention

Primary Outcomes

Recurrence rate after surgery (TUR-BT)
time frame: 2 years

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 20 years up to 80 years old.

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

Additional Information

Official title Phase II Study of Bladder Cancer Using Novel Tumor Antigens for Prevention of the Recurrence for Bladder Cancer After TUR-Bt
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2011.
Information provided to ClinicalTrials.gov by Iwate Medical University.