Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

March 17, 2008
March 17, 2008
May 2007
January 2008   (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
No Changes Posted
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.
 
Active, not recruiting
18
March 2008
January 2008   (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
Department of Surgery, Tokyo Women's Medical University Medical Center East
Tokyo Women's Medical University
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
March 2008

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