Peptide Vaccine Focusing on Prevention of the Recurrence for Bladder Cancer

• Sponsor: Iwate Medical University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00633204
• Collaborator: Human Genome Center, Institute of Medical Science, University of Tokyo (Other)
• Enrollment: 150
• Location: 1
• Duration (Months): 45
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer	Biological: MPHOSPH1 and DEPDC1	Phase 2

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-A2402 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-A2402. 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Phase II Study of Bladder Cancer Using Novel Tumor Antigens for Prevention of the Recurrence for Bladder Cancer After TUR-Bt
• Study Start Date: Feb 1, 2008
• Anticipated Primary Completion Date: Nov 1, 2011
• Anticipated Study Completion Date: Nov 1, 2011

Outcome Measures

Primary Outcome Measures

1. Recurrence rate after surgery (TUR-BT) [2 years]

Secondary Outcome Measures

1. feasibility [2 years]

2. CTL response [2 years]

3. CD8 population [2 years]

4. Change in level of regulatory T cells [2 years]

5. Overall survival [5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Iwate Medical University School of Medicine	Morioka	Iwate	Japan	020-8505

Sponsors and Collaborators

• Iwate Medical University
• Human Genome Center, Institute of Medical Science, University of Tokyo

Investigators

• Study Chair: Tomoaki Fujioka, M.D. & Ph.D., Department of Urology, Iwate Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00633204
• Other Study ID Numbers: IMU-H18-59-P2
• First Posted: Mar 11, 2008
• Last Update Posted: Jun 23, 2011
• Last Verified: Jan 1, 2009

• Keywords provided by , ,: Epitope peptide, CTL, TUR-Bt, Bladder cancer, Vaccination; Bladder cancer after surgery
• Additional relevant MeSH terms: Urinary Bladder Neoplasms; Recurrence

Study Results

No Results Posted as of Jun 23, 2011