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


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.


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

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 after the 1st vaccination

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Koji Kono, MD.PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Yamanashi, First Deparment of Surgery

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

YMU-02

NCT ID:

NCT00995358

Start Date:

November 2008

Completion Date:

October 2011

Related Keywords:

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

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