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

Sponsors and Collaborators:	Kinki University Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by:	Kinki University
ClinicalTrials.gov Identifier:	NCT00753844

Purpose

The purpose of this study it to evaluate the safety and immune response of peptides (URLC10) emulsified with Montanide ISA51 in treating patients with unresectable, advanced or recurrent esophageal cancer.

Condition	Intervention	Phase
Esophageal Cancer	Biological: URLC10	Phase I

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:	Tumor Vaccine Therapy Against Advanced Esophageal Cancer Using HLA-A*2402 Restricted Epitope Peptides Drived From URLC10

Further study details as provided by Kinki University:

Primary Outcome Measures:

Safety(Phase I:toxicities as assessed by NCI CTCAE version3) [ Time Frame: 28 days after beginning protocol ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

efficacy(Feasibility as evaluated by RECIST) [ Time Frame: 28 days after beginning protocol ] [ Designated as safety issue: No ]
evaluate immunological responses [ Time Frame: 28 days after beginning protocol ] [ Designated as safety issue: No ]

Estimated Enrollment:	6
Study Start Date:	November 2006
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Biological: URC10 Patients will be vaccinated once in one week to the eighth vaccine and will be vaccinated once in two weeks from the ninth vaccine. On each vaccination day, the URLC10 peptide (1mg) mixed with Montanide ISA 51 will be administered by endodermic injection.

Detailed Description:

URLC10 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 are upregulated in human esophageal tumors. We identified that peptides derived from these proteins significantly induce the effective tumor specific CTL response in vitro. According to these findings, in this trial, we evaluate the safety, immunological and clinical response of URLC10 peptide. Patients will be vaccinated once in one week to the eighth vaccine and will be vaccinated once in two weeks from the ninth vaccine. On each vaccination day, the URLC10 peptide (1mg) mixed with Montanide ISA 51 will be administered by endodermic injection

Eligibility

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

Criteria

Inclusion Criteria:

Patients must have Advanced or recurrent esophageal cancer, and treatment has failed, or in the situation where effective therapy is not available, or has been refused due to severe adverse effects of chemotherapy
WHO performance status of 0 to 2
Age ≥ 20 years, ≤80 years
The patient does not need to have a measurable disease, but must have a disease that an effect judgment is possible
Passing from previous treatment more than two weeks. Passing from radiation therapy more than four weeks.
Expected survival of at least 3 months
WBC≥ 1,500/mm³ WBC≤ 15,000/mm³ Platelet count ≥ 50,000/mm³ Total bilirubin ≤ 3 x the institutional normal upper limits AST, ALT ≤ 3 x the institutional normal upper limits Creatinine ≤ 3 x the institutional normal upper limits
Patients must be HLA-A2402
Able and willing to give valid written informed consent

Exclusion Criteria:

Pregnancy, Promise of the pregnancy, Hope of the pregnancy, Breastfeeding
Serious infections requiring antibiotics
Concurrent treatment with steroids or immunosuppressing agent
Disease to the central nervous system
Decision of unsuitableness by principal investigator or physician-in-charge

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00753844

Locations

Japan, Osaka
department of surgery, Kinki University
377-2,Ohno-higashi,Osaka-Sayama, Osaka, Japan, 589-8511

Sponsors and Collaborators

Kinki University

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

More Information

No publications provided

Responsible Party:	Kinki University ( Hajime Ishikawa )
Study ID Numbers:	18-29
Study First Received:	September 16, 2008
Last Updated:	February 18, 2009
ClinicalTrials.gov Identifier:	NCT00753844 History of Changes
Health Authority:	Japan: Institutional Review Board

Keywords provided by Kinki University:

peptide vaccine
URLC10

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