Status:
COMPLETED
Human Leukocyte Antigen (HLA) - A*2402 Restricted Peptide Vaccine Therapy in Patients With Advanced Esophageal Cancer
Lead Sponsor:
Kinki University
Collaborating Sponsors:
Human Genome Center, Institute of Medical Science, University of Tokyo
Conditions:
Esophageal Cancer
Eligibility:
All Genders
20-80 years
Phase:
PHASE1
Brief Summary
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 ca...
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 b...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00753844
Start Date
November 1 2006
End Date
July 1 2009
Last Update
April 6 2012
Active Locations (1)
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1
department of surgery, Kinki University
Sayama, Osaka, Japan, 589-8511