Peptide Vaccination in Treating Patients With Esophageal Cancer - Full Text View

Sponsor:	University of Yamanashi
Collaborator:	Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by:	University of Yamanashi
ClinicalTrials.gov Identifier:	NCT00682227

Purpose

The purpose of this study is to evaluate the safety and immunological monitoring for peptide vaccination therapy using novel cancer testis antigens for locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma

Condition	Intervention	Phase
Esophageal Cancer	Biological: TTK, LY6K, and IMP-3 peptides	Phase I

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Phase I Study of Peptide Vaccination Therapy Using Novel Cancer Testis Antigens for Locally Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders Testicular Disorders

U.S. FDA Resources

Further study details as provided by University of Yamanashi:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Immunological and clinical response [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	August 2006
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Biological: TTK, LY6K, and IMP-3 peptides Each of three peptides (1mg) mixed with IFA (1ml) were injected every week at five round.

Detailed Description:

We recently identified three HLA-A2402-restricted epitope peptides (TTK protein kinase (TTK), lymphocyte antigen 6 complex locus K (LY6K), and insulin-like growth factor (IGF)-II mRNA binding protein 3 (IMP-3)) derived from novel Cancer-Testis antigens (CTA) for the development of immunotherapies against esophageal squamous cell carcinoma (ESCC), and reported that the pre-existence of specific T cell responses to these epitope peptides were frequently seen in ESCC patients. Then, we performed Phase I vaccination trial using multi-epitopes involving TTK, LY6K, and IMP-3 peptides for locally advanced, recurrent or metastatic esophageal squamous cell carcinoma who had failed for the standard therapy. Each of three HLA-A2402-restricted epitope peptides mixed with IFA were injected every week at five round. Primary endpoints were to evaluate the safety and feasibility of the therapy. Secondary endpoints were to investigate the immunological monitoring and clinical effect.

Eligibility

Ages Eligible for Study:	20 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

DISEASE CHARACTERISTICS 1. Locally advanced, recurrent or metastatic esophageal squamous cell carcinoma who had failed for the standard therapy

PATIENTS CHARACTERISTICS

ECOG performance status 0-2
Age≧20 years, 80≦years　　
WBC≥ 2,000/mm³ Platelet count ≥ 75,000/mm³ Total bilirubin ≤ 2.0 x the institutional normal upper limits AST, ALT, ALP ≤ 2.5 x the institutional normal upper limits Creatinine ≤ 1.5 x the institutional normal upper limits
Patients must be HLA-A2402
Able and willing to give valid written informed consent

Exclusion Criteria:

Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
Breastfeeding
Serious bleeding disorder
Serious infections requiring antibiotics
Concomitant treatment with steroids or immunosuppressing agent
Decision of unsuitableness by principal investigator or physician-in-charge

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00682227

Contacts

Contact: Koji Kono, M.D. & Ph.D.	+81-55-273-1111 ext 2337	kojikono@yamanashi.ac.jp
Contact: Hideki Fujii, MD, PhD	+81-55-273-1111 ext 2337	hfujii@yamanashi.ac.jp

Locations

Japan, Yamanashi
University of Yamanashi, First Department of Surgery	Recruiting
1110 Shimokato, Chuo-city, Yamanashi, Japan, 409-3898
Principal Investigator: Koji Kono, MD, PhD

Sponsors and Collaborators

University of Yamanashi

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

Investigators

Principal Investigator:

Koji Kono, MD.PhD

First Depatment of Surgery

More Information

Publications:

Lin YM, Furukawa Y, Tsunoda T, Yue CT, Yang KC, Nakamura Y. Molecular diagnosis of colorectal tumors by expression profiles of 50 genes expressed differentially in adenomas and carcinomas. Oncogene. 2002 Jun 13;21(26):4120-8.

Hasegawa S, Furukawa Y, Li M, Satoh S, Kato T, Watanabe T, Katagiri T, Tsunoda T, Yamaoka Y, Nakamura Y. Genome-wide analysis of gene expression in intestinal-type gastric cancers using a complementary DNA microarray representing 23,040 genes. Cancer Res. 2002 Dec 1;62(23):7012-7.

Suda T, Tsunoda T, Daigo Y, Nakamura Y, Tahara H. Identification of human leukocyte antigen-A24-restricted epitope peptides derived from gene products upregulated in lung and esophageal cancers as novel targets for immunotherapy. Cancer Sci. 2007 Sep 2; [Epub ahead of print]

Ishikawa N, Takano A, Yasui W, Inai K, Nishimura H, Ito H, Miyagi Y, Nakayama H, Fujita M, Hosokawa M, Tsuchiya E, Kohno N, Nakamura Y, Daigo Y. Cancer-testis antigen lymphocyte antigen 6 complex locus K is a serologic biomarker and a therapeutic target for lung and esophageal carcinomas. Cancer Res. 2007 Dec 15;67(24):11601-11.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Kono K, Mizukami Y, Daigo Y, Takano A, Masuda K, Yoshida K, Tsunoda T, Kawaguchi Y, Nakamura Y, Fujii H. Vaccination with multiple peptides derived from novel cancer-testis antigens can induce specific T-cell responses and clinical responses in advanced esophageal cancer. Cancer Sci. 2009 Aug;100(8):1502-9. Epub 2009 May 14.

Responsible Party:	First Department of Surgery ( Koji Kono )
Study ID Numbers:	YMU-01
Study First Received:	May 20, 2008
Last Updated:	May 23, 2008
ClinicalTrials.gov Identifier:	NCT00682227 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by University of Yamanashi:

Epitope peptide, CTL, Esophageal cancer, Vaccination

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Digestive System Neoplasms
Gastrointestinal Diseases
Esophageal Neoplasms
Carcinoma
Neoplasms
Digestive System Diseases

Neoplasms by Site
Head and Neck Neoplasms
Gastrointestinal Neoplasms
Esophageal Diseases
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009