Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Kazuhiko Yoshimatsu
With
Human Genome Center, Institute of Medical Science, University of Tokyo
RNF43 is a cancer testis antigen which express widely in colorectal cancer tissue but not in normal organs. RNF43-721 induces HLA A24 restricted specific cytotoxic T lymphocytes (CTL) against RNF43 expressed target. S-1/CPT-11 chemotherapy is performed unresectable advanced colorectal cancer in Japan and is reported to be obtained almost the same result compared with FOLFOX or FOLFIRI as first-line chemotherapy for advanced colorectal cancer. Because synergistic effect between vaccine therapy and chemotherapy will be expected, we plan phase I study to evaluate the safety and immune response of different doses of RNF43-721 emulsified with Montanide ISA 51 in combination with S-1/CPT-11 chemotherapy.
Age
20–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
ECOG performance status 0-1
Life expectancy \> 3 months
HLA A24 positive
Histologically diagnosed as colorectal cancer with measurable lesion
Laboratory values as follows:WBC\>3000/mm3, Hb\>10mg/dl, Plt\>75000/mm3, Creatinine\<1.2mg/dl, T. bil.\<1.5mg/dl, AST, ALT\<3x normal limits
Able and willing to give valid written informed consent
You may not be if
Active other malignancy
Active infection
Immune deficiency
Current treatment with steroids and immunosuppressive agents