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

This study has been completed.
Sponsor:
Collaborator:
Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by (Responsible Party):
Kazuhiko Yoshimatsu, Tokyo Women's Medical University
ClinicalTrials.gov Identifier:
NCT00641615
First received: March 17, 2008
Last updated: May 11, 2015
Last verified: May 2015

March 17, 2008
May 11, 2015
May 2007
July 2011   (final data collection date for primary outcome measure)
Safety (toxicities as assessed by NCI CTCAE version 3) [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00641615 on ClinicalTrials.gov Archive Site
Specific CTL induction in vitro, Objective rate as assessed by RECST criteria [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Peptide Vaccine and S-1/CPT-11 Therapy for Patients With Unresectable Advanced Colorectal Cancer
Phase I Study of Peptide Vaccine and S-1 Plus CPT-11 Chemotherapy in Patients With Unresectable Recurrent or Metastatic Colorectal Cancer

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.

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
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Cancer
Biological: RNF43-721
Doses of 0.5mg, 1.0mg, 3.0mg/body/week
Other Name: S-1/CPT-11
Experimental: Phase 1
Intervention: Biological: RNF43-721

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00641615
TWMU1035
Yes
Kazuhiko Yoshimatsu, Tokyo Women's Medical University
Kazuhiko Yoshimatsu
Human Genome Center, Institute of Medical Science, University of Tokyo
Principal Investigator: Kazuhiko Yoshimatsu, MD Tokyo Women's Medical University Medical Center East
Tokyo Women's Medical University
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP