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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01267578

Enrollment

Registered

2010-12-28

Start date

2010-04-30

Completion date

2012-05-31

Last updated

2010-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer

Keywords

Epitope peptide, CTL, Esophageal cancer, Vaccination

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.

Interventions

BIOLOGICALvaccination

Biological/Vaccine: URLC10, CDCA1, and KOC1 peptides

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

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 -

Design outcomes

Primary

Measure	Time frame
overall survival	death from start of treatment

Secondary

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

Countries

Japan

Contacts

Primary ContactKoji Kono, PhD, MD

kojikono@yamanashi.ac.jp+81552737390

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026