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Sponsors and Collaborators: |
Tokyo Women's Medical University Human Genome Center, Institute of Medical Science, University of Tokyo |
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Information provided by: | Tokyo Women's Medical University |
ClinicalTrials.gov Identifier: | NCT00641615 |
The purpose of this study is 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.
Condition | Intervention | Phase |
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Colorectal Cancer |
Biological: RNF43-721 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety Study |
Official Title: | Phase I Study of Peptide Vaccine and S-1 Plus CPT-11 Chemotherapy in Patients With Unresectable Recurrent or Metastatic Colorectal Cancer |
Estimated Enrollment: | 18 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | March 2008 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Phase 1: Experimental |
Biological: RNF43-721
Doses of 0.5mg, 1.0mg, 3.0mg/body/week
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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.
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Japan | |
Tokyo Women's Medical University Medical Center East | |
Tokyo, Japan, 116-8567 |
Principal Investigator: | Kazuhiko Yoshimatsu, MD | Tokyo Women's Medical University Medical Center East |
Responsible Party: | Tokyo Women's Medical University Medical Center East ( Department of Surgery ) |
Study ID Numbers: | TWMU1035 |
Study First Received: | March 17, 2008 |
Last Updated: | March 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00641615 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Irinotecan Colonic Diseases Gastrointestinal Neoplasms |
Intestinal Diseases Antineoplastic Agents, Phytogenic Rectal Diseases Intestinal Neoplasms Recurrence Colorectal Neoplasms |
Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Colonic Diseases Irinotecan Enzyme Inhibitors Intestinal Diseases Rectal Diseases |
Pharmacologic Actions Intestinal Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Gastrointestinal Neoplasms Antineoplastic Agents, Phytogenic Colorectal Neoplasms |