Peptide Vaccination in Treating Patients With Esophageal Cancer

Esophageal Cancer Clinical Trial

Official title:

Phase I Study of Peptide Vaccination Therapy Using Novel Cancer Testis Antigens for Locally Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00682227
• Other study ID #: YMU-01
• Status: Unknown status
• Phase: Phase 1
• First received: May 20, 2008
• Last updated: May 23, 2008
• Start date: August 2006
• Est. completion date: December 2009

Study information

• Verified date: May 2008
• Source: University of Yamanashi
• Contact: Koji Kono, M.D. & Ph.D.
• Phone: +81-55-273-1111
• Email: kojikono[@]yamanashi.ac.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and immunological monitoring for peptide vaccination therapy using novel cancer testis antigens for locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma

Description:

We recently identified three HLA-A2402-restricted epitope peptides (TTK protein kinase (TTK), lymphocyte antigen 6 complex locus K (LY6K), and insulin-like growth factor (IGF)-II mRNA binding protein 3 (IMP-3)) derived from novel Cancer-Testis antigens (CTA) for the development of immunotherapies against esophageal squamous cell carcinoma (ESCC), and reported that the pre-existence of specific T cell responses to these epitope peptides were frequently seen in ESCC patients. Then, we performed Phase I vaccination trial using multi-epitopes involving TTK, LY6K, and IMP-3 peptides for locally advanced, recurrent or metastatic esophageal squamous cell carcinoma who had failed for the standard therapy. Each of three HLA-A2402-restricted epitope peptides mixed with IFA were injected every week at five round. Primary endpoints were to evaluate the safety and feasibility of the therapy. Secondary endpoints were to investigate the immunological monitoring and clinical effect.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 10
• Est. completion date: December 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• DISEASE CHARACTERISTICS 1. Locally advanced, recurrent or metastatic esophageal squamous cell carcinoma who had failed for the standard therapy

PATIENTS CHARACTERISTICS

1. ECOG performance status 0-2

2. Age?20 years, 80?years

3. WBC= 2,000/mm³ Platelet count = 75,000/mm³ Total bilirubin = 2.0 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

4. Patients must be HLA-A2402

5. 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 bleeding disorder

4. Serious infections requiring antibiotics

5. Concomitant treatment with steroids or immunosuppressing agent

6. Decision of unsuitableness by principal investigator or physician-in-charge

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Biological:
• TTK, LY6K, and IMP-3 peptides
Each of three peptides (1mg) mixed with IFA (1ml) were injected every week at five round.

Locations

Country	Name	City	State
Japan	University of Yamanashi, First Department of Surgery	1110 Shimokato, Chuo-city	Yamanashi

Sponsors (2)

Lead Sponsor	Collaborator
University of Yamanashi	Human Genome Center, Institute of Medical Science, University of Tokyo

Country where clinical trial is conducted

Japan, 

References & Publications (4)

Hasegawa S, Furukawa Y, Li M, Satoh S, Kato T, Watanabe T, Katagiri T, Tsunoda T, Yamaoka Y, Nakamura Y. Genome-wide analysis of gene expression in intestinal-type gastric cancers using a complementary DNA microarray representing 23,040 genes. Cancer Res. 2002 Dec 1;62(23):7012-7. — View Citation

Ishikawa N, Takano A, Yasui W, Inai K, Nishimura H, Ito H, Miyagi Y, Nakayama H, Fujita M, Hosokawa M, Tsuchiya E, Kohno N, Nakamura Y, Daigo Y. Cancer-testis antigen lymphocyte antigen 6 complex locus K is a serologic biomarker and a therapeutic target for lung and esophageal carcinomas. Cancer Res. 2007 Dec 15;67(24):11601-11. — View Citation

Lin YM, Furukawa Y, Tsunoda T, Yue CT, Yang KC, Nakamura Y. Molecular diagnosis of colorectal tumors by expression profiles of 50 genes expressed differentially in adenomas and carcinomas. Oncogene. 2002 Jun 13;21(26):4120-8. — 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety (toxicities as assessed by NCI CTCAE version 3)		3 months
Secondary	Immunological and clinical response		1 year