Status:
UNKNOWN
A Study With Peptide Vaccination in Treating Patients With Esophageal Cancer
Lead Sponsor:
University of Yamanashi
Collaborating Sponsors:
Human Genome Center, Institute of Medical Science, University of Tokyo
Conditions:
Esophageal Cancer
Eligibility:
All Genders
20-80 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate overall survival and immunological monitoring for peptide vaccination therapy using novel cancer testis antigens for locally advanced, recurrent, or metastatic...
Detailed Description
The phase I vaccination study using peptides derived from TTK, LY6K, and IMP-3 for locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) who had failed for the standard t...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS
- Locally advanced, recurrent or metastatic esophageal squamous cell carcinoma who had failed for the standard therapy
- PATIENTS CHARACTERISTICS
- ECOG performance status 0-2
- Age≧ 20≦ 80years
- WBC≥ 2,000/mm³ Platelet count ≥ 75,000/mm³ Total bilirubin ≤ 2.0 x the institutional normal upper limits AST, ALT, ALP ≤ 2.5 x the institutional normal upper limits Creatinine ≤ 1.5 x the institutional normal upper limits
- No therapy 4 weeks prior to the initiation of the trial
- Able and willing to give valid written informed consent
Exclusion
- Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
- Breastfeeding
- Serious bleeding disorder
- Serious infections requiring antibiotics
- Concomitant treatment with steroids or immunosuppressing agent
- Decision of unsuitableness by principal investigator or physician-in-charge
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00995358
Start Date
November 1 2008
End Date
October 1 2011
Last Update
October 15 2009
Active Locations (1)
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1
First Department of Surgery, University of Yamanashi
Chūō, Yamanashi, Japan, 409-3898