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

Colorectal Cancer Clinical Trial

Official title:

Phase I Study of Peptide Vaccine and S-1 Plus CPT-11 Chemotherapy in Patients With Unresectable Recurrent or Metastatic Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00641615
• Other study ID #: TWMU1035
• Status: Completed
• Phase: Phase 1
• First received: March 17, 2008
• Last updated: May 11, 2015
• Start date: May 2007
• Est. completion date: July 2011

Study information

• Verified date: May 2015
• Source: Tokyo Women's Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Biological:
• RNF43-721
Doses of 0.5mg, 1.0mg, 3.0mg/body/week

Locations

Country	Name	City	State
Japan	Tokyo Women's Medical University Medical Center East	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Kazuhiko Yoshimatsu	Human Genome Center, Institute of Medical Science, University of Tokyo

Country where clinical trial is conducted

Japan, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety (toxicities as assessed by NCI CTCAE version 3)		2 months	Yes
Secondary	Specific CTL induction in vitro, Objective rate as assessed by RECST criteria		2 months	No