Safety Study of Multiple Peptide Vaccine to Esophageal Cancer
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ClinicalTrials.gov Identifier: NCT00561275
Recruitment Status :
First Posted : November 20, 2007
Last Update Posted : July 15, 2008
Japanese Foundation for Cancer Research
Human Genome Center, Institute of Medical Science, University of Tokyo
This is a phase 1 study of multiple peptide vaccine therapy and GM-CSF in treating patients with esophageal cancer.
Condition or disease
Biological: LY6K, VEGFR1, VEGFR2
LY6K (lymphocyte antigen 6 complex, locus K) was identified as a new target of tumor associated antigen using cDNA microarray technologies combined with the expression profiles of normal and cancer tissues. On the other hand, anti-angiogenic therapy is now considered to be one of promising approaches to treat of cancer. In this clinical trial, we evaluate the safety and immune responses of multiple peptide cocktail including LY6K and vascular endothelial growth factor receptor 1 (VEGFR1) and vascular endothelial growth factor receptor 2 (VEGFR2) together with IFA and GM-CSF as immunoadjuvants in patients who had LY6K expressed primary esophageal cancer. Toxicity profiles will be monitored, and antigen specific T cell responses will be described.
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Ages Eligible for Study:
20 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients must have metastatic disease of 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, ≤75 years
Chemotherapy, any type of radiation therapy, or immunotherapy within 4 weeks before study entry
Expected survival of at least 3 months
WBC≥ 2,000/mm³ Platelet count ≥ 100,000/mm³ Total bilirubin ≤ 1.5 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
Patients must be HLA-A2402
Primary lesion of esophageal cancer must express LY6K
Able and willing to give valid written informed consent
Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
Serious infections requiring antibiotics
Patient with peptic ulcer disease
Previous history of intestinal perforation
bleeding disorders (INR ≥ 1.5)
Necessity of drug-mediated inhibition with platelet function
Taking antithrombogenic agents within 10 days
Previous history of arterial thrombosis or venous thrombosis
Other malignancy within 5 years prior to entry into the study, except for treated non-melanoma skin cancer and cervical carcinoma in situ
Clinically significant heart disease or previous history of myocardial infarction within the past 12 months
Concomitant treatment with steroids or immunosuppressing agent
Disease to the central nervous system
Decision of unsuitableness by principal investigator or physician-in-charge