Phase II Clinical trial of personalized peptide vaccine for patients with maligant tumors (gastrointestinal cancers, hepato-biliary-pancreatic cancers, thoracic malignant tumors, non-epithelial malignant tumors, genitourinary cancers, gynecological cancers, breast cancers, and rare cancers) - Effect of extended interval dosing on immune responses
Phase 2
- Conditions
- malignant tumor
- Registration Number
- JPRN-UMIN000011230
- 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
- 800
Inclusion Criteria
Not provided
Exclusion Criteria
The following patients must be excluded: 1) Patients with severe underlying diseases (active and severe infectious diseases, cardiovascular diseases, respiratory diseases, renal diseases, immunodeficiency, disturbance of coagulation). 2) Patients with the past history of severe allergic reactions. 3) Patients who are pregnant, nursing, or want to be pregnant. Patients with no acceptance of use of effective contraception during and at least 70 days after study participation. 4) Past history of usage of peptides employed in the study. 5) Patients who are judged inappropriate for enrollmwnt in this study by the attending 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 4 doses of vaccination
- Secondary Outcome Measures
Name Time Method Adverse events and safety of personalized peptide vaccination evaluated by the CTCAE Version 4.0