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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by University of Yamanashi.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by:
University of Yamanashi
ClinicalTrials.gov Identifier:
NCT01267578
First received: December 27, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted
  Purpose

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


Condition Intervention Phase
Esophageal Cancer
Biological: vaccination
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Yamanashi:

Primary Outcome Measures:
  • overall survival [ Time Frame: death from start of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CTL response [ Time Frame: CTL response after 5 round vaccination ] [ Designated as safety issue: No ]
  • DTH response [ Time Frame: Skin reaction after 5 round vaccination ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: time from start of vaccination until disease progreesion ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2010
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: peptide vaccination Biological: vaccination
Biological/Vaccine: URLC10, CDCA1, and KOC1 peptides

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01267578

Contacts
Contact: Koji Kono, PhD, MD +81552737390 kojikono@yamanashi.ac.jp

Locations
Japan
University of Yamanashi, First Department of Surgery Recruiting
Chuo, Yamanashi, Japan, 4093898
Contact: Koji Kono, PhD, MD    +81552737390    kojikono@yamanashi.ac.jp   
Sub-Investigator: Kousaku Mimura, PhD. MD         
Sponsors and Collaborators
University of Yamanashi
Human Genome Center, Institute of Medical Science, University of Tokyo
Investigators
Principal Investigator: Koji Kono, PhD, MD University of Yamanashi, First Department of Surgery
  More Information

No publications provided

Responsible Party: First Department of Surgery, University of Yamanashi
ClinicalTrials.gov Identifier: NCT01267578     History of Changes
Other Study ID Numbers: YMU-03
Study First Received: December 27, 2010
Last Updated: December 27, 2010
Health Authority: Safety and evaluation commitee, Captivation-network : JAPAN

Keywords provided by University of Yamanashi:
Epitope peptide, CTL, Esophageal cancer, Vaccination

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on July 23, 2014