Novel Peptide Vaccination for Patients With Advanced Bladder Cancer

Phase 1

Completed

• Conditions: Bladder Cancer

• Registration Number: NCT00635336
• Lead Sponsor: Iwate Medical University

Brief Summary

The purpose of this study is to evaluate the safety and clinical efficacy of novel vaccination for advanced bladder cancer.

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. We 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 safety and efficacy of novel vaccination for the advanced bladder cancer patients who already showed resistance to standard chemotherapies or radiotherapy.

Study Timeline

• Study Start: 2007-02
• Primary Completion: 2007-02
• Study First Submitted: 2008-03-05
• Study First Submitted QC: 2008-03-12
• Study First Posted: 2008-03-13
• Status Verified: 2009-01
• Study Completion: 2010-02
• Last Update Submitted: 2010-10-20
• Last Update Posted: 2010-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

DISEASE CHARACTERISTICS

1. advanced bladder cancer which already showed resistance to standard treatments
2. Protein expression of MPHOSPH1 and DEPDC1 on the tumor

PATIENTS CHARACTERISTICS

1. Patients who showed resistance to standard chemotherapies or radiotherapy
2. Histological diagnosis is transitional cell carcinoma
3. HLA-A*2402
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. lesion 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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
feasibility (toxicities as assessed by NCI-CTCAE version 3)	3 years

Secondary Outcome Measures

Name	Time	Method
objective response rate as assessed by RECIST criteria	3 years
CTL response	3 years
CD8 population	3 years
Change in level of regulatory T cells	3 years
survival	3 years

Trial Locations

Locations (1)

Iwate Medical University School of Medicine; 🇯🇵 Morioka, Iwate, Japan