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


Phase 1
20 Years
80 Years
Open (Enrolling)
Both
Esophageal Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety (toxicities as assessed by NCI CTCAE version 3)

Outcome Time Frame:

3 months

Safety Issue:

Yes

Principal Investigator

Koji Kono, MD.PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

First Depatment of Surgery

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

YMU-01

NCT ID:

NCT00682227

Start Date:

August 2006

Completion Date:

December 2009

Related Keywords:

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

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