refractory metastatic colorectal cancer
Conditions
Interventions
1)Immune modulators, composed of cyclophosphamide, metformin, celecoxib and cimetidine are administered orally for 1 week 2)Induction phase: 5-peptide cocktail vaccine weekly in combination with immu
Sponsors
Department of Surgery, Kindai University Faculty of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)standard therapy-refractory metastatic colorectal cancer 2)HLA-A24 positive patient 3)life expectancy at least 3 months 4)older than 20 years of age 5)ECOG performance status, 0,1 or 2 6)having measurable metastatic lesion 7) WBC count more than 2,000 and % of lymphocyte more than 15% 8)adequate bone marrow, liver and renal function
Exclusion criteria
Exclusion criteria: 1)patient having double cancer 2)patient having interstitial pneumonia 3)patient having brain metastasis 4)patient having mental disorder 5)patient having uncontrollable heart disorder, pulmonary disorder or renal disorder 6)patient having bleeding tendency 7)patient having any allergic reaction to using drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety of the immune modulators with/without 5-peptide cocktail vaccine | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) peptide-specific CTL responses and the relationship with clinical responses 2)Overall survival and preogression-free survival | — |
Countries
Japan
Contacts
Public ContactJunichiro KAWAMURA
Kindai University Faculty of Medicine Department of Surgery
Outcome results
None listed