Human Leukocyte Antigen (HLA) - A*2402 Restricted Peptide Vaccine Therapy in Patients With Advanced Esophageal Cancer
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ClinicalTrials.gov Identifier: NCT00753844
Recruitment Status :
First Posted : September 17, 2008
Last Update Posted : April 6, 2012
Human Genome Center, Institute of Medical Science, University of Tokyo
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 or disease
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. The investigators 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
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.
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Ages Eligible for Study:
20 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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