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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00641615

Enrollment

Registered

2008-03-24

Start date

2007-05-31

Completion date

2011-07-31

Last updated

2015-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

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 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.

Interventions

BIOLOGICALRNF43-721

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Safety (toxicities as assessed by NCI CTCAE version 3)	2 months

Secondary

Measure	Time frame
Specific CTL induction in vitro, Objective rate as assessed by RECST criteria	2 months

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026