Safety Study of Multiple Peptide Vaccine to Esophageal Cancer

• Sponsor: Japanese Foundation for Cancer Research (Other)
• Overall Status: Completed
• CT.gov ID: NCT00561275
• Collaborator: Human Genome Center, Institute of Medical Science, University of Tokyo (Other)
• Enrollment: 6
• Location: 1
• Duration (Months): 8
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer	Biological: LY6K, VEGFR1, VEGFR2	Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase 1 Study of Multiple Peptide Vaccine Therapy and GM-CSF in Treating Patients With Esophageal Cancer
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: May 1, 2008
• Actual Study Completion Date: Jun 1, 2008

Outcome Measures

Primary Outcome Measures

1. Toxicity of multiple peptide vaccinations [one year]

Secondary Outcome Measures

1. Immune responses including LY6K, VEGFR1 and VEGFR2 specific T cells [one year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Takuya Takayama M.D.Ph.D	Tokyo		Japan	135-8550

Sponsors and Collaborators

• Japanese Foundation for Cancer Research
• Human Genome Center, Institute of Medical Science, University of Tokyo

Investigators

• Principal Investigator: Takuya Takayama, M.D.Ph.D, Cancer Institute of Japanese Foundation for Cancer Research

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• ClinicalTrials.gov Identifier: NCT00561275
• Other Study ID Numbers: TB-454
• First Posted: Nov 20, 2007
• Last Update Posted: Jul 15, 2008
• Last Verified: Jul 1, 2008

• Additional relevant MeSH terms: Esophageal Neoplasms

Study Results

No Results Posted as of Jul 15, 2008