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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Tokyo Women's Medical University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by:
Tokyo Women's Medical University
ClinicalTrials.gov Identifier:
NCT00641615
First received: March 17, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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

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

Secondary Outcome Measures:
  • Specific CTL induction in vitro, Objective rate as assessed by RECST criteria [ Time Frame: 2 months ] [ Designated as safety issue: No ]

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
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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00641615

Locations
Japan
Tokyo Women's Medical University Medical Center East
Tokyo, Japan, 116-8567
Sponsors and Collaborators
Tokyo Women's Medical University
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: Department of Surgery, Tokyo Women's Medical University Medical Center East
ClinicalTrials.gov Identifier: NCT00641615     History of Changes
Other Study ID Numbers: TWMU1035
Study First Received: March 17, 2008
Last Updated: March 17, 2008
Health Authority: Japan: Ministry of Health, Labor and Welfare

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
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013