Esophageal Cancer
Conditions
Brief summary
This is a phase 1 study of multiple peptide vaccine therapy and GM-CSF in treating patients with esophageal cancer.
Detailed description
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.
Interventions
BIOLOGICALLY6K, VEGFR1, VEGFR2
1 mg/body every two week with GM-CSF, 4 cycles
Sponsors
Human Genome Center, Institute of Medical Science, University of Tokyo
Japanese Foundation for Cancer Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. 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 2. WHO performance status of 0 to 2 3. Age ≥ 20 years, ≤75 years 4. Chemotherapy, any type of radiation therapy, or immunotherapy within 4 weeks before study entry 5. Expected survival of at least 3 months 6. 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 7. Patients must be HLA-A2402 8. Primary lesion of esophageal cancer must express LY6K 9. Able and willing to give valid written informed consent
Exclusion criteria
1. Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception) 2. Breastfeeding 3. Serious infections requiring antibiotics 4. Patient with peptic ulcer disease 5. Previous history of intestinal perforation 6. bleeding disorders (INR ≥ 1.5) 7. Necessity of drug-mediated inhibition with platelet function 8. Taking antithrombogenic agents within 10 days 9. Serious hypertension 10. Previous history of arterial thrombosis or venous thrombosis 11. Other malignancy within 5 years prior to entry into the study, except for treated non-melanoma skin cancer and cervical carcinoma in situ 12. Clinically significant heart disease or previous history of myocardial infarction within the past 12 months 13. Concomitant treatment with steroids or immunosuppressing agent 14. Disease to the central nervous system 15. Decision of unsuitableness by principal investigator or physician-in-charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Toxicity of multiple peptide vaccinations | one year |
Secondary
| Measure | Time frame |
|---|---|
| Immune responses including LY6K, VEGFR1 and VEGFR2 specific T cells | one year |
Countries
Japan
Outcome results
None listed