Status:
COMPLETED
Peptide Vaccine and S-1/CPT-11 Therapy for Patients With Unresectable Advanced Colorectal Cancer
Lead Sponsor:
Kazuhiko Yoshimatsu
Collaborating Sponsors:
Human Genome Center, Institute of Medical Science, University of Tokyo
Conditions:
Colorectal Cancer
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief Summary
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.
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 ex...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00641615
Start Date
May 1 2007
End Date
July 1 2011
Last Update
May 12 2015
Active Locations (1)
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1
Tokyo Women's Medical University Medical Center East
Tokyo, Japan, 116-8567