Histocompatibility Leukocyte Antigen (HLA)-A*2402 Restricted Peptide Vaccine Therapy in Patients With Esophageal Cancer - Full Text View

Sponsors and Collaborators:	Tokyo University Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by:	Tokyo University
ClinicalTrials.gov Identifier:	NCT00681330

Purpose

The purpose of this study is to evaluate the safety and time to progression of HLA-A*2402 restricted epitope peptides URLC10, TTK, and KOC1, emulsified with Montanide ISA 51.

Condition	Intervention	Phase
Esophageal Cancer	Biological: URC10, TTK, KOC1	Phase I Phase II

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase I/II Study of Multiple-Vaccine Therapy Using Epitope Peptide Restricted to HLA-A*2402 in Treating Patients With Refractory Esophageal Cancer

Further study details as provided by Tokyo University:

Primary Outcome Measures:

Safety(Phase I:toxicities as assessed by NCI CTCAE version3) and efficacy(Phase II:Feasibility as evaluated by RECIST) [ Time Frame: Two months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate immunological responses [ Time Frame: Two months ] [ Designated as safety issue: No ]

Estimated Enrollment:	14
Study Start Date:	May 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Biological: URC10, TTK, KOC1 Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, the URLC10 peptide (1mg), KOC1 peptide (1mg) and TTK peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.

Detailed Description:

URLC10, KOC1 and TTK have been identified as cancer specific molecules especially in non small cell lung cancer using genome-wide expression profile analysis by cDNA microarray technique. In a prior study, it has been shown that URLC10, KOC1 and TTK are upregulated in human esophageal tumors. We identified that peptides derived from these proteins significantly induce the effective tumor specific CTL response in vitro and vivo. According to these findings, in this trial, we evaluate the safety, immunological and clinical response of those peptides. Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, the URLC10 peptide (1mg), KOC1 peptide (1mg), and TTK peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection. Repeated cycles of vaccine will be administered until patients develop progressive disease or unacceptable toxicity, whichever occurs first. In the phase I study, we evaluate the safety and tolerability of these peptide vaccines. In the following phase II study, we evaluate the immunological and clinical response of this vaccine therapy.

Eligibility

Ages Eligible for Study:	20 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Advanced or recurrent esophageal cancer
Resistant against conventional chemotherapy or difficult to continue the chemotherapy due to intolerable side effect(s)
ECOG performance status 0-2
Life expectancy > 3 months
HLA-A*2402
Laboratory values as follows 2000/mm3<WBC<15000/mm3 Platelet count>100000/mm3 Bilirubin < 3.0mg/dl Asparate transaminase < 150IU/L Alanine transaminase < 150IU/L Creatinine < 3.0mg/dl
Able and willing to give valid written informed consent

Exclusion Criteria:

Pregnancy (woman of childbearing potential:Refusal or inability to use effective means of contraception)
Breastfeeding
Active or uncontrolled infection
Concurrent treatment with steroids or immunosuppressing agent
Prior chemotherapy, radiation therapy, and/or immunotherapy within 4 weeks
Uncontrolled brain and/or intraspinal metastasis
Decision of unsuitableness by principal investigator or physician-in-charge

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00681330

Locations

Japan, Tokyo
The Institutute of Medical Science, University of Tokyo
4-6-1, Shirokanedai, Minato-ku, Tokyo, Japan, 108-8639

Sponsors and Collaborators

Tokyo University

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

Investigators

Study Chair:

Naohide Yamashita, MD/PhD

The Institutute of Medical Science, University of Tokyo

More Information

Publications:

Okabe H, Satoh S, Kato T, Kitahara O, Yanagawa R, Yamaoka Y, Tsunoda T, Furukawa Y, Nakamura Y. Genome-wide analysis of gene expression in human hepatocellular carcinomas using cDNA microarray: identification of genes involved in viral carcinogenesis and tumor progression. Cancer Res. 2001 Mar 1;61(5):2129-37.

Wada S, Tsunoda T, Baba T, Primus FJ, Kuwano H, Shibuya M, Tahara H. Rationale for antiangiogenic cancer therapy with vaccination using epitope peptides derived from human vascular endothelial growth factor receptor 2. Cancer Res. 2005 Jun 1;65(11):4939-46.

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.

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.

Responsible Party:	Institute of Medical Science, University of Tokyo ( Naohida Yamashita, MD/PhD )
Study ID Numbers:	IMS-OKA2402
Study First Received:	May 19, 2008
Last Updated:	February 5, 2009
ClinicalTrials.gov Identifier:	NCT00681330 History of Changes
Health Authority:	Japan: Institutional Review Board

Keywords provided by Tokyo University:

Peptide Vaccine
URLC10
TTK
KOC1

Study placed in the following topic categories:

Digestive System Neoplasms
Digestive System Diseases
Esophageal Disorder
Gastrointestinal Diseases
Head and Neck Neoplasms

Esophageal Neoplasms
Gastrointestinal Neoplasms
Esophageal Cancer
Esophageal Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

Head and Neck Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Esophageal Diseases

ClinicalTrials.gov processed this record on May 07, 2009