A phase II clinical trial of personalized peptide vaccination in combination with metformin for castration-resistant prostate cancer (CRPC)
- Conditions
- Castration-resistant prostate cancer
- Registration Number
- JPRN-UMIN000019879
- Lead Sponsor
- Cancer Vaccine Center, Kurume University School of medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 35
Not provided
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)Active double cancer (synchronous double cancer and metachronous double cancer within 5 disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) judged to have been cured with local treatment. 3) Patients with the past history of severe allergic reactions. 4) Patients who do not accept contraception from the 1st vaccination until 70 days after the last vaccination. 5) Patients who are judged inappropriate for entry to this clinical trial by doctors.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of immune responses by measurement of cytotoxic T lymphocytes (CTL)and anti-peptide IgG) before and after peptide vaccination with metformin.
- Secondary Outcome Measures
Name Time Method 1.Evaluation of long-term prognosis (progression free survival and overall survival). 2.Adverse effects of peptide vaccination / The safety of the protocol is evaluated based on the NCI-CTC.