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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


Phase 2
20 Years
80 Years
Open (Enrolling)
Both
Bladder Cancer

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Trial Information

Phase II Study of Bladder Cancer Using Novel Tumor Antigens for 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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

Recurrence rate after surgery (TUR-BT)

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Tomoaki Fujioka, M.D. & Ph.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Department of Urology, Iwate Medical University

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

IMU-H18-59-P2

NCT ID:

NCT00633204

Start Date:

February 2008

Completion Date:

November 2011

Related Keywords:

  • Bladder Cancer
  • Epitope peptide, CTL, TUR-Bt, Bladder cancer, Vaccination
  • Bladder cancer after surgery
  • Urinary Bladder Neoplasms
  • Recurrence

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