Phase I Clinical trial of personalized peptide vaccine in combination with humanized anti-IL6 receptor monoclonal antibody for refractory colorectal cancer patients
- Conditions
- colorectal cancer patients refractory to conventional treatments
- Registration Number
- JPRN-UMIN000007493
- 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
- 18
Not provided
The following patients must be excluded: 1) Patients with severe underlying diseases (active and severe infectious diseases, activa tuberculosis, circulatory diseases, respiratory diseases, renal diseases, immunodeficiency, disturbance of coagulation, etc). 2) Patients with active interstitial pneumonia or its past history. 3) Patients with active double cancer [synchronic double cancer or asynchronous double cancer with no more than 5-year disease-free period, excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) judged to have been cured by local treatment]. 4) Patients with the past history of severe allergic reactions. 5) Patients with Castleman's disease, rheumatoid arthritis, or juvenile idiopathic arthritis or with the past history of them. 6) Patients with the past history of previous tretamnet with anti-IL-6 receptor antibody. 7) Patients with the past history of previous tretament with personalized peptide vaccine developed by Kurume University. 8) Pregnant, nursing, or who wants pregnancy. Patients with no acceptance of effective contraception during and for at least 70 days after study participation. 9) Patients with other inappropriate conditions for enrollment judged by the clinicians.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety (adverse events) of personalized peptide vaccine in combination with anti-IL6 receptor antibody.
- Secondary Outcome Measures
Name Time Method Specific immunological responses after peptide vaccine (anti-peptide IgG titers in plasma and peptide-specific CTL responses in PBMC) .