Phase II clinical trial of personalized peptide vaccination for patients with colon cancer refractory to standard treatment.
Phase 2
- Conditions
- colon cancer
- Registration Number
- JPRN-UMIN000006493
- 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
- 100
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) (Females) Patients who are during pregnancy, lactation expectant, and desiring future fertility. (Males) 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 immunological responses (anti-peptide IgG) before and after peptide vaccination.
- Secondary Outcome Measures
Name Time Method 1.Analyze the correlation between enhancement of peptide specific antibody and all over survival. 2. Adverse effects and safety of peptide vaccination is evaluated based on the NCI-CTC.