Peptide Vaccination in Treating Patients With Esophageal Cancer (STF-II)

Esophageal Cancer Clinical Trial

Official title:

Phase II Multicenter Trial of Peptide Vaccination Therapy Using Novel Cancer Testis Antigens (STF-II) for Locally Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01267578
• Other study ID #: YMU-03
• Status: Recruiting
• Phase: Phase 2
• First received: December 27, 2010
• Last updated: December 27, 2010
• Start date: April 2010
• Est. completion date: May 2012

Study information

• Verified date: December 2010
• Source: University of Yamanashi
• Contact: Koji Kono, PhD, MD
• Phone: +81552737390
• Email: kojikono[@]yamanashi.ac.jp
• Is FDA regulated: No
• Health authority: Safety and evaluation commitee, Captivation-network : JAPAN
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate overall survival and immunological monitoring for peptide vaccination therapy using novel cancer testis antigens (STF-II) for locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma

Description:

The phase II multicenter trial of vaccination study using peptides derived from URLC10, CDCA1, and KOC1 for locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) who had failed for the standard therapy are performed to evaluate the survival benefit of the cancer vaccination.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2012
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• 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. No therapy 4 weeks prior to the initiation of the trial

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 -

Study Design

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Biological:
• vaccination
Biological/Vaccine: URLC10, CDCA1, and KOC1 peptides

Locations

Country	Name	City	State
Japan	University of Yamanashi, First Department of Surgery	Chuo	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 (1)

1. Okabe H, Satoh S, Kato T, et al. Genome-wide analysis of gene expression in human hepatocellular carcinomas using cDNA microarray: identification of genes involved in viral carcinogenesis and tumor progression. Cancer Res 2001; 61: 2129-37. 2 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; 21: 4120-28. 3. Hasegawa S, Furukawa Y, Li M, et al. Genome-wide analysis of gene expression in intestinal-type gastric cancers using a complementary DNA microarray representing 23,040 genes. Cancer Res 2002; 62: 7012-17. 4. 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; 98: 1803-8. 5. Ishikawa N, Takano A, Yasui W, et al. 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; 67: 11601-11. 6. Yoshiki Mizukami, Koji Kono, Yataro Daigo, et al. Detection of novel Cancer-Testis antigen-specific T-cell responses in TIL, regional lymph nodes and PBL in patients with esophageal squamous cell carcinoma. Cancer Science 2008 ;99:1448-54 6. Koji Kono, Yoshiki Mizukami, Yataro Daigo, Atsushi Takano, Ken Masuda, Koji Yoshida, Takuya Tsunoda, Yoshihiko Kawaguchi, Yusuke Nakamura, and Hideki Fujii. Vaccination with Multiple Peptides derived from Novel Cancer-Testis Antigens Can Induce Specific T-Cell Responses and Clinical Responses in Advanced Esophageal cancer. Cancer Sci. 2009;100:1502-9.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		death from start of treatment	No
Secondary	CTL response		CTL response after 5 round vaccination	No
Secondary	DTH response		Skin reaction after 5 round vaccination	No
Secondary	Progression free survival		time from start of vaccination until disease progreesion	No