Novel Peptide Vaccination for Patients With Advanced Bladder Cancer

Sponsor

Iwate Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT00635336

Collaborator

Human Genome Center, Institute of Medical Science, University of Tokyo (Other)

Enrollment

Location

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer	Biological: MPHOSPH1 and DEPDC1	Phase 1

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase I Study of Vaccination With MPHOSHP1 and DEPDC1 Derived Epitope Peptides for HLA-A-24-positive Patients With Advanced Bladder Cancer

Study Start Date :

Feb 1, 2007

Actual Primary Completion Date :

Feb 1, 2007

Actual Study Completion Date :

Feb 1, 2010

Outcome Measures

Primary Outcome Measures

feasibility (toxicities as assessed by NCI-CTCAE version 3) [3 years]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

DISEASE CHARACTERISTICS

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

PATIENTS CHARACTERISTICS

Patients who showed resistance to standard chemotherapies or radiotherapy
Histological diagnosis is transitional cell carcinoma
HLA-A*2402
ECOG performance status of 0 to 1
Age ≥ 20 years, ≤80 years
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
lesion of bladder cancer must express MPHOSPH1 or DEPDC1
Able and willing to give valid written informed consent

Exclusion Criteria:

Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
Breastfeeding
Patients willing to childbearing ( Refusal or inability to use effective means of contraception)
Serious infections requiring antibiotics
Concomitant treatment with steroids or immunosuppressing agent
Other malignancy difficult to control.
Decision of unsuitableness by principal investigator or physician-in-charge