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

NCT ID: NCT00641615

Last Updated: 2015-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2011-07-31

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase 1

Group Type: EXPERIMENTAL

RNF43-721

Intervention Type: BIOLOGICAL

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

Interventions

RNF43-721

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

Intervention Type: BIOLOGICAL

Other Intervention Names

S-1/CPT-11

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Human Genome Center, Institute of Medical Science, University of Tokyo

OTHER

Sponsor Role: collaborator

Kazuhiko Yoshimatsu

OTHER

Sponsor Role: lead

Responsible Party

Kazuhiko Yoshimatsu

Ascociate professor of surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kazuhiko Yoshimatsu, MD

Role: PRINCIPAL_INVESTIGATOR

Tokyo Women's Medical University Medical Center East

Locations

Tokyo Women's Medical University Medical Center East

Tokyo, , Japan

Countries

Japan

References

Uchida N, Tsunoda T, Wada S, Furukawa Y, Nakamura Y, Tahara H. Ring finger protein 43 as a new target for cancer immunotherapy. Clin Cancer Res. 2004 Dec 15;10(24):8577-86. doi: 10.1158/1078-0432.CCR-04-0104.

Reference Type: BACKGROUND

PMID: 15623641 (View on PubMed)

Yoshimatsu K, Yokomizo H, Fujimoto T, Umehara A, Otani T, Matsumoto A, Osawa G, Ogawa K. Pilot study of simplified low-dose S-1 plus CPT-11 as first-line chemotherapy for patients with advanced colorectal cancer. Anticancer Res. 2007 May-Jun;27(3B):1657-61.

Reference Type: BACKGROUND

PMID: 17595792 (View on PubMed)

Other Identifiers

TWMU1035

Identifier Type: -

Identifier Source: org_study_id