Trial | NCT00561275  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    6
This is a phase 1 study of multiple peptide vaccine therapy and GM-CSF in treating patients with esophageal cancer.
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.
Study Started
Oct 31
2007
Primary Completion
May 31
2008
Study Completion
Jun 30
2008
Last Update
Jul 15
2008
Estimate

Biological LY6K, VEGFR1, VEGFR2

1 mg/body every two week with GM-CSF, 4 cycles

Criteria 

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
No Results Posted