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

Kazuhiko Yoshimatsu18 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colorectal Cancer

Interventions

RNF43-721BIOLOGICAL

Doses of 0.5mg, 1.0mg, 3.0mg/body/week

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Tokyo Women's Medical University Medical Center East

Tokyo, Japan

Outcomes

Primary Outcomes

Safety (toxicities as assessed by NCI CTCAE version 3)

Time frame: 2 months

Secondary Outcomes

Specific CTL induction in vitro, Objective rate as assessed by RECST criteria

Time frame: 2 months

Data from ClinicalTrials.gov

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