Survivin-expressing advanced/recurrent colorectal cancer patients or patients who refuse standard cancer therapy
Conditions
Interventions
Sponsors
Department of Gastroenterological Surgery I, Hokkaido University Graduated School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Aged 20 to 75 years 2) Histologically-confirmed malignant colorectal cancer (adenocarcinoma) 3) Patients with therapy-resistant recurrent cancer treated at least one chemotherapy or radio therapy, or the patients who refuse the subsequent standard therapy 4) Performance status (ECOG) 0 to 2 5) At least four-month life expectancy 6) Normal bone-marrow, kidney and liver function, meeting the criteria below; Neutrophils>1500/microL Lymphocytes>500/microL Platelets>100000/microL Hemoglobin>8.0 g/dL Serum serum bilirubin<2.0 mg/dL Serum creatinine<2.0 mg/dL 7) Available for pathological specimen, more than 10 slides to perform immunostaining 8) Patients with PCR/ IHC-confirmed Survivin expressing tumor cells 9) Positive for HLA-DRB1*01:01, HLA-DRB1*08:03, HLA-DR53 (DR4/DR7/DR9), HLA-DQB1*06:01, HLA-DPB1*05:01. 10) Having written informed consent
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactKitamura Hidemitsu
Division of Immunoregulation, Institute for Genetic Medicine, Hokkaido University Bureau of Survivin peptide vaccine clinical study
Outcome results
None listed