A phase II clinical trial of the metformin extra combination for the personalized peptide vaccine resistance patients who is not complicatrd with diabetes.
Phase 2
- Conditions
- The patients whom a symptom aggravates without being complicated with diabetes of various personalized peptide vaccine phase II trial entries.
- Registration Number
- JPRN-UMIN000020306
- Lead Sponsor
- Kurume University Cancer Vaccine Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
Not provided
Exclusion Criteria
The following patients must be excluded. 1)Patients with severe underlying diseases/conditions (active and severe infectious diseases, circulatory diseases, respiratory diseases, renal diseases, immunodeficiency, disturbance of coagulation, et al.) 2)Patients with the past history of severe allergic reactions. 3)(Female)Pregnant or nursing patients. (Male)Patients who do not accept contraception from the 1st vaccination to 70 days after last vaccination. 4)Patients who are judjed inappropriate for entry to this clinical trial by doctors.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assesment of immunoresponses by mesuremant of peptide specific IgGs before and after peptide vaccination with metformin.
- Secondary Outcome Measures
Name Time Method Safety assessments Clinical response(Overall survival)