Bladder cancer
Conditions
Interventions
Arm 1: personalized peptide vaccine plus best supportive care (BSC) (1st treatment: total 8 times, every weeks) Day 1: Select peptide candidates (up to 4), to which peptide-specific IgGs are detecte
Sponsors
Kurume University Research Center for Innovative Cancer Therapy, Clinical Research Division
Hirosaki University , Dokkyou University, Kitasato University, Kinki University, Okayama University, Kyushu University, Fukuoka University, Kumamoto University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The subjects must satisfy the following conditions. 1) Patients require histologically confirmed locally advanced or metastatic bladder cancer and documented after first-line platinum containing chemotherapy. 2) Patients in arm 1 must be positive for HLA-A2, -A24, -A26 or HLA-A3 super type(A3, A11, A31 or A33). 3) Patients in arm 1 must have IgG reactive to at least two of peptide candidates. 4) Prior treatment are allowed and must complete 4 weeks before random assignment with full recovery of related toxicity. 5) Patients must be at a score level of 0-1 of performance status (PS) (ECOG). 6) Patients must be expected to survive more than 3 months. 7) Patients must satisfy the followings: WBC > 2,500/mm3 Lymphocyte > 1,000/mm3 Hb > 8.0g/dl Platelet > 100,000/mm3 Serum Creatinine < 2 x upper limit of normal Total Bilirubin > 2 x upper limit of normal 8) Patients require to have adequate organ function. 9) Patients must be more 18 year-old. 10) Written informed consent must be obtained from patients.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of antitumor activity (progression free survival) of peptide vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactAkira Yamada
Kurume University Research Center for Innovative Cancer Therapy, Cancer Vaccine Division
Outcome results
None listed