Safety Study of Multiple Peptide Vaccine to Esophageal Cancer

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00561275
• Other study ID #: TB-454
• Status: Completed
• Phase: Phase 1
• First received: November 14, 2007
• Last updated: July 10, 2008
• Start date: October 2007
• Est. completion date: June 2008

Study information

• Verified date: July 2008
• Source: Japanese Foundation for Cancer Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Japan	Takuya Takayama M.D.Ph.D	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Japanese Foundation for Cancer Research	Human Genome Center, Institute of Medical Science, University of Tokyo

Country where clinical trial is conducted

Japan, 

References & Publications (3)

Ishizaki H, Tsunoda T, Wada S, Yamauchi M, Shibuya M, Tahara H. Inhibition of tumor growth with antiangiogenic cancer vaccine using epitope peptides derived from human vascular endothelial growth factor receptor 1. Clin Cancer Res. 2006 Oct 1;12(19):5841-9. — View Citation

Suda T, Tsunoda T, Daigo Y, Nakamura Y, Tahara H. Identification of human leukocyte antigen-A24-restricted epitope peptides derived from gene products upregulated in lung and esophageal cancers as novel targets for immunotherapy. Cancer Sci. 2007 Nov;98(11):1803-8. — View Citation

Wada S, Tsunoda T, Baba T, Primus FJ, Kuwano H, Shibuya M, Tahara H. Rationale for antiangiogenic cancer therapy with vaccination using epitope peptides derived from human vascular endothelial growth factor receptor 2. Cancer Res. 2005 Jun 1;65(11):4939-46. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity of multiple peptide vaccinations		one year	Yes
Secondary	Immune responses including LY6K, VEGFR1 and VEGFR2 specific T cells		one year	Yes