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.
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
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.
department of surgery, Kinki University
Sayama, Osaka, Japan
Safety(Phase I:toxicities as assessed by NCI CTCAE version3)
Time frame: 28 days after beginning protocol
efficacy(Feasibility as evaluated by RECIST)
Time frame: 28 days after beginning protocol
evaluate immunological responses
Time frame: 28 days after beginning protocol
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