NCT00682227

Brief Summary

The purpose of this study is to evaluate the safety and immunological monitoring for peptide vaccination therapy using novel cancer testis antigens for locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2006

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

May 29, 2008

Status Verified

May 1, 2008

Enrollment Period

2.3 years

First QC Date

May 20, 2008

Last Update Submit

May 23, 2008

Conditions

Esophageal Cancer

Keywords

Epitope peptide, CTL, Esophageal cancer, Vaccination

Outcome Measures

Primary Outcomes (1)

  • Safety (toxicities as assessed by NCI CTCAE version 3)

    3 months

Secondary Outcomes (1)

  • Immunological and clinical response

    1 year

Study Arms (1)

1

EXPERIMENTAL
Biological: TTK, LY6K, and IMP-3 peptides

Interventions

TTK, LY6K, and IMP-3 peptidesBIOLOGICAL

Each of three peptides (1mg) mixed with IFA (1ml) were injected every week at five round.

1

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • DISEASE CHARACTERISTICS 1. 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 years, 80≦years
  • 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
  • Patients must be HLA-A2402
  • Able and willing to give valid written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Yamanashi, First Department of Surgery

1110 Shimokato, Chuo-city, Yamanashi, 409-3898, Japan

RECRUITING

Related Publications (5)

  • Lin YM, Furukawa Y, Tsunoda T, Yue CT, Yang KC, Nakamura Y. Molecular diagnosis of colorectal tumors by expression profiles of 50 genes expressed differentially in adenomas and carcinomas. Oncogene. 2002 Jun 13;21(26):4120-8. doi: 10.1038/sj.onc.1205518.

    PMID: 12037668BACKGROUND

  • Hasegawa S, Furukawa Y, Li M, Satoh S, Kato T, Watanabe T, Katagiri T, Tsunoda T, Yamaoka Y, Nakamura Y. Genome-wide analysis of gene expression in intestinal-type gastric cancers using a complementary DNA microarray representing 23,040 genes. Cancer Res. 2002 Dec 1;62(23):7012-7.

    PMID: 12460921BACKGROUND

  • Suda T, Tsunoda T, Daigo Y, Nakamura Y, Tahara H. Identification of human leukocyte antigen-A24-restricted epitope peptides derived from gene products upregulated in lung and esophageal cancers as novel targets for immunotherapy. Cancer Sci. 2007 Nov;98(11):1803-8. doi: 10.1111/j.1349-7006.2007.00603.x.

    PMID: 17784873BACKGROUND

  • Ishikawa N, Takano A, Yasui W, Inai K, Nishimura H, Ito H, Miyagi Y, Nakayama H, Fujita M, Hosokawa M, Tsuchiya E, Kohno N, Nakamura Y, Daigo Y. Cancer-testis antigen lymphocyte antigen 6 complex locus K is a serologic biomarker and a therapeutic target for lung and esophageal carcinomas. Cancer Res. 2007 Dec 15;67(24):11601-11. doi: 10.1158/0008-5472.CAN-07-3243.

    PMID: 18089789BACKGROUND

  • Kono K, Mizukami Y, Daigo Y, Takano A, Masuda K, Yoshida K, Tsunoda T, Kawaguchi Y, Nakamura Y, Fujii H. Vaccination with multiple peptides derived from novel cancer-testis antigens can induce specific T-cell responses and clinical responses in advanced esophageal cancer. Cancer Sci. 2009 Aug;100(8):1502-9. doi: 10.1111/j.1349-7006.2009.01200.x. Epub 2009 May 14.

    PMID: 19459850DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

LY6K protein, human

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

  • Koji Kono, MD.PhD

    First Depatment of Surgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Koji Kono, M.D. & Ph.D.

CONTACT

+81-55-273-1111kojikono@yamanashi.ac.jp

Hideki Fujii, MD, PhD

CONTACT

+81-55-273-1111hfujii@yamanashi.ac.jp

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 20, 2008

First Posted

May 22, 2008

Study Start

August 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2009

Last Updated

May 29, 2008

Record last verified: 2008-05

Locations

JP(1)