A Study With Peptide Vaccination in Treating Patients With Esophageal Cancer

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00995358
• Other study ID #: YMU-02
• Status: Recruiting
• Phase: Phase 2
• First received: October 8, 2009
• Last updated: October 14, 2009
• Start date: November 2008
• Est. completion date: October 2011

Study information

• Verified date: October 2009
• Source: University of Yamanashi
• Contact: Koji Kono, MD,PhD
• Phone: +81-55-273-1111
• Email: kojikono[@]yamanashi.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• 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 for locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC).

Description:

The phase I vaccination study using peptides derived from TTK, LY6K, and IMP-3 for locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) who had failed for the standard therapy indicated that the vaccine treatment were well tolerated and feasible, and that antigen-specific T cell responses were strongly induced by the vaccination with some objective clinical responses. Thus, we are currently initiating the randomized phase II clinical vaccination study for the same cohort with ESCC to evaluate the survival benefit of the cancer vaccination.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

DISEASE CHARACTERISTICS

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

PATIENTS CHARACTERISTICS

• ECOG performance status 0-2

• Age? 20? 80years

• 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

• No therapy 4 weeks prior to the initiation of the trial

• Able and willing to give valid written informed consent

Exclusion Criteria:

• Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)

• Breastfeeding

• Serious bleeding disorder

• Serious infections requiring antibiotics

• Concomitant treatment with steroids or immunosuppressing agent

• 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:
• peptide
Each of three peptides (1mg) mixed with IFA (1ml) were injected every week at five round.

Locations

Country	Name	City	State
Japan	First Department of Surgery, University of Yamanashi	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, F

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival after the 1st vaccination		2 years	No
Secondary	Antigen specific control response induced by vaccination		1 year	No
Secondary	DTH response induced by vaccination		1 year	No
Secondary	Time to progression after the 1st vaccination		1 year	No