Peptide Vaccination in Treating Patients With Esophageal Cancer

Phase 1

• Conditions: Esophageal Cancer
• Interventions: Biological: TTK, LY6K, and IMP-3 peptides

• Registration Number: NCT00682227
• Lead Sponsor: University of Yamanashi

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2006-08
• Status Verified: 2008-05
• Study First Submitted: 2008-05-20
• Study First Submitted QC: 2008-05-20
• Study First Posted: 2008-05-22
• Last Update Submitted: 2008-05-23
• Last Update Posted: 2008-05-29
• Primary Completion: 2008-12
• Study Completion: 2009-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	TTK, LY6K, and IMP-3 peptides	-

Primary Outcome Measures

Name	Time	Method
Safety (toxicities as assessed by NCI CTCAE version 3)	3 months

Secondary Outcome Measures

Name	Time	Method
Immunological and clinical response	1 year

Trial Locations

Locations (1)

University of Yamanashi, First Department of Surgery; 🇯🇵 1110 Shimokato, Chuo-city, Yamanashi, Japan