Phase I Study of Peptide Vaccine and S-1 Plus CPT-11 Chemotherapy in Patients With Unresectable Recurrent or Metastatic Colorectal Cancer
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.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety (toxicities as assessed by NCI CTCAE version 3)
2 months
Yes
Kazuhiko Yoshimatsu, MD
Principal Investigator
Tokyo Women's Medical University Medical Center East
Japan: Ministry of Health, Labor and Welfare
TWMU1035
NCT00641615
May 2007
March 2008
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