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

Phase 2

• Conditions: Esophageal Cancer
• Interventions: Biological: vaccination

• Registration Number: NCT01267578
• Lead Sponsor: University of Yamanashi

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2010-04
• Status Verified: 2010-12
• Study First Submitted: 2010-12-27
• Study First Submitted QC: 2010-12-27
• Last Update Submitted: 2010-12-27
• Study First Posted: 2010-12-28
• Last Update Posted: 2010-12-28
• Primary Completion: 2011-05
• Study Completion: 2012-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
peptide vaccination	vaccination	-

Primary Outcome Measures

Name	Time	Method
overall survival	death from start of treatment

Secondary Outcome Measures

Name	Time	Method
Progression free survival	time from start of vaccination until disease progreesion
DTH response	Skin reaction after 5 round vaccination
CTL response	CTL response after 5 round vaccination

Trial Locations

Locations (1)

University of Yamanashi, First Department of Surgery; 🇯🇵 Chuo, Yamanashi, Japan