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Peptide Vaccine and S-1/CPT-11 Therapy for Patients With Unresectable Advanced Colorectal Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00641615
First Posted: March 24, 2008
Last Update Posted: May 12, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by (Responsible Party):
Kazuhiko Yoshimatsu, Tokyo Women's Medical University
  Purpose
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
Colorectal Cancer Biological: RNF43-721 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Peptide Vaccine and S-1 Plus CPT-11 Chemotherapy in Patients With Unresectable Recurrent or Metastatic Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Kazuhiko Yoshimatsu, Tokyo Women's Medical University:

Primary Outcome Measures:
  • Safety (toxicities as assessed by NCI CTCAE version 3) [ Time Frame: 2 months ]

Secondary Outcome Measures:
  • Specific CTL induction in vitro, Objective rate as assessed by RECST criteria [ Time Frame: 2 months ]

Enrollment: 18
Study Start Date: May 2007
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phase 1 Biological: RNF43-721
Doses of 0.5mg, 1.0mg, 3.0mg/body/week
Other Name: S-1/CPT-11

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Active other malignancy
  • Active infection
  • Immune deficiency
  • Current treatment with steroids and immunosuppressive agents
  • Pregnancy and breast feeding
  • Inability oral intake
  • Psychic disease
  • Hepatitis B, C virus
  • HIV infection
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00641615


Locations
Japan
Tokyo Women's Medical University Medical Center East
Tokyo, Japan, 116-8567
Sponsors and Collaborators
Kazuhiko Yoshimatsu
Human Genome Center, Institute of Medical Science, University of Tokyo
Investigators
Principal Investigator: Kazuhiko Yoshimatsu, MD Tokyo Women's Medical University Medical Center East
  More Information

Publications:
Responsible Party: Kazuhiko Yoshimatsu, Ascociate professor of surgery, Tokyo Women's Medical University
ClinicalTrials.gov Identifier: NCT00641615     History of Changes
Other Study ID Numbers: TWMU1035
First Submitted: March 17, 2008
First Posted: March 24, 2008
Last Update Posted: May 12, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Irinotecan
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action