Peptide Vaccine Focusing on Prevention of the Recurrence for Bladder Cancer

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00633204
• Other study ID #: IMU-H18-59-P2
• Status: Active, not recruiting
• Phase: Phase 2
• First received: March 4, 2008
• Last updated: June 22, 2011
• Start date: February 2008
• Est. completion date: November 2011

Study information

• Verified date: January 2009
• Source: Iwate Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the clinical efficacy for the 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Japan	Iwate Medical University School of Medicine	Morioka	Iwate

Sponsors (2)

Lead Sponsor	Collaborator
Iwate Medical University	Human Genome Center, Institute of Medical Science, University of Tokyo

Country where clinical trial is conducted

Japan, 

References & Publications (2)

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. Epub 2007 Apr 23. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence rate after surgery (TUR-BT)		2 years	Yes
Secondary	feasibility		2 years	Yes
Secondary	CTL response		2 years	No
Secondary	CD8 population		2 years	No
Secondary	Change in level of regulatory T cells		2 years	No
Secondary	Overall survival		5 years	Yes