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

Sponsors and Collaborators:	Tokyo Women's Medical University Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by:	Tokyo Women's Medical University
ClinicalTrials.gov Identifier:	NCT00641615

Purpose

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.

Condition	Intervention	Phase
Colorectal Cancer	Biological: RNF43-721	Phase I

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety Study
Official Title:	Phase I Study of Peptide Vaccine and S-1 Plus CPT-11 Chemotherapy in Patients With Unresectable Recurrent or Metastatic Colorectal Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Irinotecan U 101440E Irinotecan hydrochloride S 1 (Combination)

U.S. FDA Resources

Further study details as provided by Tokyo Women's Medical University:

Primary Outcome Measures:

Safety (toxicities as assessed by NCI CTCAE version 3) [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Specific CTL induction in vitro, Objective rate as assessed by RECST criteria [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	18
Study Start Date:	May 2007
Estimated Study Completion Date:	March 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Phase 1: Experimental	Biological: RNF43-721 Doses of 0.5mg, 1.0mg, 3.0mg/body/week

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.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00641615

Locations

Japan
Tokyo Women's Medical University Medical Center East
Tokyo, Japan, 116-8567

Sponsors and Collaborators

Tokyo Women's Medical University

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

Investigators

Principal Investigator:

Kazuhiko Yoshimatsu, MD

Tokyo Women's Medical University Medical Center East

More Information

Publications:

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.

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.

Responsible Party:	Tokyo Women's Medical University Medical Center East ( Department of Surgery )
Study ID Numbers:	TWMU1035
Study First Received:	March 17, 2008
Last Updated:	March 17, 2008
ClinicalTrials.gov Identifier:	NCT00641615 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Irinotecan
Colonic Diseases
Gastrointestinal Neoplasms

Intestinal Diseases
Antineoplastic Agents, Phytogenic
Rectal Diseases
Intestinal Neoplasms
Recurrence
Colorectal Neoplasms

Additional relevant MeSH terms:

Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gastrointestinal Diseases
Colonic Diseases
Irinotecan
Enzyme Inhibitors
Intestinal Diseases
Rectal Diseases

Pharmacologic Actions
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Gastrointestinal Neoplasms
Antineoplastic Agents, Phytogenic
Colorectal Neoplasms

ClinicalTrials.gov processed this record on September 10, 2009