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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


Phase 2
20 Years
80 Years
Open (Enrolling)
Both
Esophageal Cancer

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Trial Information

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


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.


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 -

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

overall survival

Outcome Time Frame:

death from start of treatment

Safety Issue:

No

Principal Investigator

Koji Kono, PhD, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Yamanashi, First Department of Surgery

Authority:

Safety and evaluation commitee, Captivation-network : JAPAN

Study ID:

YMU-03

NCT ID:

NCT01267578

Start Date:

April 2010

Completion Date:

May 2012

Related Keywords:

  • Esophageal Cancer
  • Epitope peptide, CTL, Esophageal cancer, Vaccination
  • Carcinoma, Squamous Cell
  • Esophageal Diseases
  • Esophageal Neoplasms

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