A phase II clinical study of cancer vaccine with Survivin helper peptide for patients with advanced/recurrent colorectal cancers
- Conditions
- Survivin-expressing advanced/recurrent colorectal cancer patients or patients who refuse standard cancer therapy
- Registration Number
- JPRN-UMIN000007506
- Lead Sponsor
- Department of Gastroenterological Surgery I, Hokkaido University Graduated School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 35
Not provided
1) Patients treated with other cancer therapy within 4 weeks before the first vaccine 2) Patients treated with cancer immunotherapy for Survivin 3) Severe bleeding disorders, meeting the criteria below; PT<50% APTT>60sec 4) Active infection (HIV, HBV or HCV HTLV-1) 5) Severe heart disease (NYHA class 3 or 4) 6) Autoimmune disease (scleroderma, Sjogren's syndrome, idiopathic thrombocytopenic purpura, multiple sclerosis, rheumatoid arthritis etc.) 7) Systemic administration of corticosteroid or immunosuppresive drugs during the study (Except local administration, inhaled drugs, and antiphlogistic analgetics). 8) Brain metastasis 9) Multiple primary cancer 10)Patients with adverse events more than Grade 3 (non-hematological toxicity ) or Grade 4 (hematological toxicity) based on CTCAEv4.0 11)Pregnant women or refuse anticonception during the study (both sexes) Patient with impaired mental status in the study. 12) Lactating women or cannot stop lactation during the study. 13) Men refused anticonception during the study 14) Inappropriate for study entry judged by an attending physician.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Tumor response: Disease control rate (DCR), best over- all response assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) after Survivin helper peptide vaccine
- Secondary Outcome Measures
Name Time Method Safety: profiles of adverse events, Immune responses : Survivin-specific antibodies and T cell responses, Tumor responses: Response rate, Clinical benefit rate, Overall survival, Disease Free survival, Time to progression, Progression free survival, Median Survival time, Tumor markers: CEA, CA19-9, Diagnostic imaging: CT, MRI, PET, K-ras, Bio-markers. Evaluation of correlation between tumor responses and immune responses.