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

Primary Purpose

Colorectal Cancer

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

RNF43-721

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Tokyo Women's Medical University Medical Center East

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Phase 1

Arm Description

Outcomes

Primary Outcome Measures

Safety (toxicities as assessed by NCI CTCAE version 3)

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00641615

First Posted

March 17, 2008

Last Updated

May 11, 2015

Sponsor

Kazuhiko Yoshimatsu

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT00641615

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

May 2007 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Kazuhiko Yoshimatsu

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Phase 1

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

RNF43-721

Other Intervention Name(s)

S-1/CPT-11

Intervention Description

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

Primary Outcome Measure Information:

Title

Safety (toxicities as assessed by NCI CTCAE version 3)

Time Frame

2 months

Secondary Outcome Measure Information:

Title

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

Time Frame

2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kazuhiko Yoshimatsu, MD

Organizational Affiliation

Tokyo Women's Medical University Medical Center East

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tokyo Women's Medical University Medical Center East

City

Tokyo

ZIP/Postal Code

116-8567

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

15623641

Citation

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.

Results Reference

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PubMed Identifier

17595792

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.

Results Reference

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Learn more about this trial

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

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