Phase II study of personalized peptide vaccination in bladder cancer patients progressing after first-line platinum-containing regime
Phase 2
- Conditions
- Bladder cancer
- Registration Number
- JPRN-UMIN000003157
- Lead Sponsor
- Kurume University Research Center for Innovative Cancer Therapy, Clinical Research Division
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
Not provided
Exclusion Criteria
The following patients must be excluded: 1) Patients with severe symptoms (active and severe infectious disease, circulatory disease, respiratory disease, kidney disease, immunodeficiency, disturbance of coagulation). 2) Patients with the past history of severe allergic reactions. 3) Patients do not accept contraception during the 1st vaccination to 70 days after the last vaccination. 4) Patients who are judged inappropriate for the clinical trial by doctors.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of antitumor activity (progression free survival) of peptide vaccination.
- Secondary Outcome Measures
Name Time Method 1.Evaluation of response rate and long-term prognosis (overall survival). 2.Adverse effects of peptide vaccination / The safety of the protocol is evaluated based on the NCI-CTCAE (v 4.0). 3.Evaluation of immunological responses (anti-peptide IgG) before and after peptide vaccination.