Know Cancer

forgot password

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

Phase 1
20 Years
75 Years
Not Enrolling
Esophageal Cancer

Thank you

Trial Information

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.

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

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity of multiple peptide vaccinations

Outcome Time Frame:

one year

Safety Issue:


Principal Investigator

Takuya Takayama, M.D.Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute of Japanese Foundation for Cancer Research


Japan: Institutional Review Board

Study ID:




Start Date:

October 2007

Completion Date:

June 2008

Related Keywords:

  • Esophageal Cancer
  • Esophageal Diseases
  • Esophageal Neoplasms