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Peptide Vaccination in Treating Patients With Esophageal Cancer

Primary Purpose

Esophageal Cancer

Status
Unknown status
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
TTK, LY6K, and IMP-3 peptides
Sponsored by
University of Yamanashi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring Epitope peptide, CTL, Esophageal cancer, Vaccination

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Yamanashi, First Department of SurgeryRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Safety (toxicities as assessed by NCI CTCAE version 3)

Secondary Outcome Measures

Immunological and clinical response

Full Information

First Posted
May 20, 2008
Last Updated
May 23, 2008
Sponsor
University of Yamanashi
Collaborators
Human Genome Center, Institute of Medical Science, University of Tokyo
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1. Study Identification

Unique Protocol Identification Number
NCT00682227
Brief Title
Peptide Vaccination in Treating Patients With Esophageal Cancer
Official Title
Phase I Study of Peptide Vaccination Therapy Using Novel Cancer Testis Antigens for Locally Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Unknown status
Study Start Date
August 2006 (undefined)
Primary Completion Date
December 2008 (Anticipated)
Study Completion Date
December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Yamanashi
Collaborators
Human Genome Center, Institute of Medical Science, University of Tokyo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
Epitope peptide, CTL, Esophageal cancer, Vaccination

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
TTK, LY6K, and IMP-3 peptides
Intervention Description
Each of three peptides (1mg) mixed with IFA (1ml) were injected every week at five round.
Primary Outcome Measure Information:
Title
Safety (toxicities as assessed by NCI CTCAE version 3)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Immunological and clinical response
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Koji Kono, M.D. & Ph.D.
Phone
+81-55-273-1111
Ext
2337
Email
kojikono@yamanashi.ac.jp
First Name & Middle Initial & Last Name or Official Title & Degree
Hideki Fujii, MD, PhD
Phone
+81-55-273-1111
Ext
2337
Email
hfujii@yamanashi.ac.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Koji Kono, MD.PhD
Organizational Affiliation
First Depatment of Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Yamanashi, First Department of Surgery
City
1110 Shimokato, Chuo-city
State/Province
Yamanashi
ZIP/Postal Code
409-3898
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Koji Kono, MD, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
12037668
Citation
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.
Results Reference
background
PubMed Identifier
12460921
Citation
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.
Results Reference
background
PubMed Identifier
17784873
Citation
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.
Results Reference
background
PubMed Identifier
18089789
Citation
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.
Results Reference
background
PubMed Identifier
19459850
Citation
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.
Results Reference
derived

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Peptide Vaccination in Treating Patients With Esophageal Cancer

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