Safety Study of Multiple Peptide Vaccine to Esophageal Cancer

Study Overview
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Brief Summary
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This is a phase 1 study of multiple peptide vaccine therapy and GM-CSF in treating patients with esophageal cancer.

Detailed Description
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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.

Official Title
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Phase 1 Study of Multiple Peptide Vaccine Therapy and GM-CSF in Treating Patients With Esophageal Cancer

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Biological: LY6K, VEGFR1, VEGFR2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception) Breastfeeding 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 Serious hypertension 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: LY6K, VEGFR1, VEGFR2|1 mg/body every two week with GM-CSF, 4 cycles|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity of multiple peptide vaccinations |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immune responses including LY6K, VEGFR1 and VEGFR2 specific T cells |  | one year |